USA v. Pourhassan et al

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IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MARYLAND
UNITED STATES OF AMERICA 	*
v. 	* 	Criminal Case No. PX 22-440
NADER POURHASSAN
KAZEM KAZEMPOUR, 	*
Defendants.
******
MEMORANDUM OPINION
Presently pending are motions to undo the jury verdict in this matter. Defendants Nader
Pourhassan 	(“Pourhassan”) 	and 	Kazem 	Kazempour 	(“Kazempour”) 	separately 	moved 	for
judgment of acquittal, or in the alternative, for a new trial. ECF Nos. 311 and 312. The motions
are fully briefed, and after a hearing, supplemental briefing, and serious consideration, the Court
DENIES the motions for judgment of acquittal, GRANTS Kazempour’s motion for new trial, and
DENIES Pourhassan’s new trial motion.
I. 	Background
This case concerns the multi-year efforts of Pourhassan and Kazempour to bring an
experimental 	drug, 	Leronlimab, 	to 	market 	for 	the 	treatment 	of 	advanced 	HIV-positive
symptomatic patients and for COVID-19. 	During the relevant times, Pourhassan was the CEO of
CytoDyn, a publicly traded company responsible for developing solely Leronlimab. Kazempour
was the CEO of Amarex, a contract research organization with specialized experience in assisting
companies like CytoDyn that seek the U.S. Food and Drug Administration (“FDA”)’s approval to
market new drugs. 	CytoDyn was Amarex’s largest client. 	Kazempour functioned as the
“regulatory agent” for CytoDyn vis the FDA. Despite Defendants’ attempts to monetize
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Leronlimab, FDA approval never came to pass and so, CytoDyn never generated any revenue apart
from stock sales.
According to the Government, from 2018 through 2021, Defendants conspired and
executed a scheme to defraud CytoDyn investors through a series of public announcements that
falsely claimed Leronlimab was on the precipice of marketability so as to artificially inflate
CytoDyn’s stock price. 	After a three-week trial, the jury rendered a split verdict as to both
Defendants. Now each seeks relief from the verdicts. To place the pending motions in context,
the Court first summarizes the relevant trial evidence, and next the fourteen-count indictment and
subsequent verdict.
II. 	Evidence Developed at Trial
A. Leronlimab for HIV
Central to the HIV-related fraud was CytoDyn’s efforts to obtain from the FDA a license
to market Leronlimab for treatment of particularly severe HIV-symptomatic patients. The research
and development of a drug culminates in a “completed” Biologics License Application (“BLA”)
to the FDA, which the FDA then takes under consideration to determine if it will license the drug
to market. ECF No. 286, Tr. Vol. 2 at 180. Once an applicant like CytoDyn submits a completed
BLA, the FDA screens the submission to determine if it is sufficiently complete to permit
substantive review. 	Id. at 185. If the BLA is not complete, the FDA will issue what is known as
a “refuse to file” letter to the company which effectively ends the BLA process. Id. An application
is “complete” only if it includes clinical research data of sufficient quantity and quality to allow
the FDA to review the drug’s safety and efficacy. Id. at 187. If the BLA is complete, the FDA
next turns to whether it will approve the drug for licensure and distribution. Id. at 186.
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Defendants began the BLA process in 2018 and engaged in several meetings with the FDA
to ascertain the BLA requirements. ECF No. 286, Tr. Vol. 2 at 187. In June of 2018, for example,
FDA representatives met with Defendants and communicated specifically that the FDA would not
consider the BLA complete unless the data from the HIV-related clinical trials was submitted in a
“reviewable format.” Id. at 215. See also GX-600.1 The FDA also expressed concerns with what
it believed to be Defendants’ overly optimistic timeline for submitting the BLA. Id. at 219.
The FDA met again with Defendants on December 14, 2018 to discuss CytoDyn’s ongoing
studies of using Leronlimab at a higher dose to treat HIV-compromised patients. ECF No. 286,
Tr. Vol. 2 at 222–24. At that meeting, the FDA again voiced concerns to Defendants about the
proposed timeline for the BLA submission because of dose adjustments in the clinical trials. Id.
at 225. 	The FDA thus suggested that CytoDyn submit “mock” datasets to make sure the data
would be reviewable, and forewarned Defendants that they could risk a “refuse to file” letter if the
BLA did not include sufficient data submitted in the correct format to justify a dose change. Id. at
230. Kazempour acknowledged in writing the FDA’s guidance. GX-21.
For the next 18 months, Defendants remained in regular contact with the FDA about the
specific requirements for the BLA. ECF No. 286, Tr. Vol. 2 at 231. At the same time, Pourhassan
recognized that CytoDyn could not generate revenue without securing the BLA, so to incentivize
its completion, he convinced the CytoDyn Board of Directors to award him and others stock
options that would vest upon the BLA’s filing. ECF No. 292, Tr. Vol. 8 at 127–28.
Pourhassan next engaged in a series of text and email communications with Kazempour
and Amarex’s chief scientist, Dr. Kush Dhody (“Dhody”), pressing for the BLA’s completion.
Pourhassan particularly communicated that the delay in filing the BLA was causing the CytoDyn
1 Trial exhibits are cited using their exhibit prefixes GX-, PX-, or KX-.
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stock price to drop. 	On January 30, 2020, for example, Pourhassan wrote to Kazempour that they
needed to file the clinical section of the BLA “as this is becoming increasingly worrisome to our
investors. Today our stock was as high as $1.53 and all of a sudden we had a selloff . . . .” GX-
119. On February 8, 2020, Pourhassan told Kazempour and Dhody that after having reported the
BLA would be delayed until the end of February, “our stock dropped and our market cap went
down by $200 million and everyone is asking for my head.” GX-6. Pourhassan went on: “If we
can’t get BLA done by the end of February we will have another tremendous drop in our stock.”
Id. 	Pourhassan also communicated directly with Kazempour that CytoDyn really needed “your
help with our BLA” because “I am losing a lot of credibility among our shareholders.” GX-310H.
Despite this, the BLA was not yet ready to file, principally because the datasets reflecting
the efficacy of Leronlimab at the new dose were not properly formatted. Pourhassan evidently
became increasingly concerned about the stock price and asked Dhody at Amarex, “what will we
be risking?” if the BLA was filed by no later than April 15. GX-28. See also GX-31. Around the
same time, Pourhassan emailed Kazempour and Dhody that CytoDyn’s stock price dropped “in 1
hour almost 20%” and that “[t]his drop will be much deeper if we don’t file our BLA as the [stock]
message board now is getting bombarded by investors who are very frustrated with me and
CytoDyn.” 	GX-2. 	Accordingly, Pourhassan directed them to “file the BLA no later than next
week Wednesday, even if we are short in no matter what portion of whatever it is that we are
short.” Id.
Two weeks later, on April 27, 2020, Kazempour filed the BLA with the FDA. 	In the
accompanying cover letter, Kazempour acknowledged that the submission did not include the data
in the format that the FDA directed, but that “[r]evised datasets will be submitted to the BLA as
an amendment in May 2020.” GX-3. 	The letter further highlighted the specific clinical sections
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of the BLA that “will be provided in [the] next amendment.” 	Id. 	As it happens, the FDA had
already received all the data previously as mock datasets. 	Missing was the submission in the
specific format that the FDA required for the BLA review. ECF No. 287, Tr. Vol. 3 at 27, 98.
Notwithstanding the BLA’s lack of completeness, CytoDyn issued a press release on the
same day, April 27, announcing that it had submitted a “completed” BLA to the FDA for
Leronlimab as a combination therapy for HIV. GX-35. The press release detailed that the BLA
included “the clinical, and the CMC (chemistry, manufacturing and controls) portions” to the FDA.
Id. Pourhassan is also quoted as saying that the BLA represented a “significant milestone for the
Company, and initiates its transition from a development-stage company to a commercial
organization.” Id. At trial, several CytoDyn investors testified about the significance of this press
release regarding their decision to invest or maintain their investments in CytoDyn. ECF No. 287,
Tr. Vol. 3 at 160; ECF No. 288, Tr. Vol. 4 at 109; ECF No. 290, Tr. Vol. 6 at 162–65.
The next day, April 28, Kazempour emailed Mike Mulholland, Chief Financial Officer for
CytoDyn, to inquire about selling warrants that had been issued to him in connection with his work
for CytoDyn. Kazempour stated, “[s]everal years ago, [the] Board of CytoDyn gave me 150,000
share options, and after this many years, I am thinking to sell the shares now!!” GX-8. Kazempour
asked Mulholland to “explain” to Kazempour or his broker “what we need to do to sell those
shares.” Id.
The day after that, April 29, the FDA directly contacted Kazempour as CytoDyn’s
regulatory agent to correct the April 27 press release. 	The FDA stated plainly that it did not
consider the BLA “complete” because of missing datasets and that the FDA review clock would
not start until “the applicant informs the Agency that a complete BLA was submitted.” GX-38.
The FDA thus demanded that Kazempour “take regulatory responsibility for the misinformation
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released in the [April 27] Press Release by notifying CytoDyn” of the FDA’s position and
“formally retract submission of the clinical module.” Id. Kazempour, in turn, informed CytoDyn
of the FDA’s position and next communicated to the FDA that the error “will be addressed in the
next press release.” GX-608.
On May 4 and 6, CytoDyn published two corrective press releases that acknowledged the
BLA was not complete when filed on April 27. Specifically, the release stated that the BLA “will
be considered completed after the clinical data sets are submitted on May 11, 2020. The clinical
datasets are updated to address FDA comments for mock datasets from March 12 and March 20,
2020.” GX-44 & GX-45. The subject of both press releases, however, was not the BLA. Rather
each discussed the status of parallel studies of Leronlimab’s use to treat COVID-19. 	Id. 	The
corrective statement about the BLA was buried within the unrelated COVID-19 discussion.
On May 11, as promised, Kazempour and Amarex submitted the missing datasets. GX-
49; ECF No. 295, Tr. Vol. 11 at 202. Two days later, CytoDyn issued a press release announcing
that it has submitted the remaining datasets for the BLA and that the FDA will begin its review
process to ascertain if the application is complete and ready for review. GX-47. Next on May 15,
Kazempour emailed Mulholland again about selling his CytoDyn shares. GX-9. 	Kazempour
exercised his warrants on May 22 and sold his shares on June 9 and 10, realizing a $300,000 gain.
GX-59; GX-906; KX-253.
Pourhassan, for his part, sold over $15 million of CytoDyn stock between April 30 and
May 4. 	GX-905. 	In connection with the stock sale, Pourhassan acknowledged his compliance
with CytoDyn’s insider trading policy, particularly that he did not possess material nonpublic
information when initiating the trades. 	E.g., ECF No. 291, Tr. Vol. 7 at 219. 	Of the revenue
generated from the stock sale, Pourhassan reinvested roughly $11 million in CytoDyn to pay taxes
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on the stock sale and satisfy an outstanding vendor bill, thus realizing about $4 million in personal
gain. ECF No. 292, Tr. Vol 8 at 122–23, ECF No. 291, Tr. Vol. 7 at 222–23; PX-961.
On July 8, 2020, the FDA issued its “refuse to file” letter, rejecting the BLA. GX-63. The
letter specifically noted that the May 11 submission did not include “all pertinent information and
data needed to complete a substantive review.” 	Id. 	CytoDyn never resubmitted a BLA for
Leronlimab’s treatment of HIV.
B. Leronlimab for COVID-19
While CytoDyn was trying to bring Leronlimab to market as an HIV treatment, the
COVID-19 pandemic descended. In short order, the FDA gave CytoDyn permission to conduct
clinical trials designed to measure the safety and efficacy of Leronlimab as an antiviral treatment
for two categories of COVID-19 patients: people with mild or moderate symptoms (the “CD 10
trial”) and a larger study of hospitalized and intubated COVID-19 patients (the “CD 12 trial”).
GX-613. Amarex conducted the clinical trials on CytoDyn’s behalf. Id.
By September 2020, the FDA had reviewed the CD 10 trial results and concluded that the
study failed to meet its “primary, secondary end points,” or study objectives, and so could not be
used as a reliable therapeutic. ECF No. 293, Tr. Vol. 9 at 268; GX-620. Nor did the FDA find
reliable CytoDyn’s identified “trends” in symptom improvements, as reflected in Amarex’s “post-
hoc analysis.” GX-620. Accordingly, the FDA refused to consider the request for emergency use
authorization (“EUA”) for the CD 10 trial and recommended that CytoDyn focus on the CD 12
trial. GX-620; ECF No. 293, Vol. 9 at 274–75.
The CD 12 trial in the FDA’s estimation, however, fared no better. The clinical results of
the CD 12 trial reflected that the drug had not met its primary and secondary endpoints. ECF No.
294, Tr. Vol. 10 at 5–6. Nonetheless, post hoc analysis of certain study “subgroups,” according to
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CytoDyn, showed therapeutic benefits to certain populations of critically ill COVID-19 patients.
ECF No. 294, Vol. 10 at 7. Pourhassan next directed that Amarex submit an “addendum” to the
FDA about the clinical significance of the CD 12 trial. GX-10 & GX-70. The addendum, however,
omitted that the results were not statistically significant, meaning that the supposed “benefits”
conferred to critically ill patients could be just as much by happenstance or some other factor apart
from true therapeutic effects of Leronlimab. GX-159. See also ECF No. 293, Tr. Vol. 9 at 226.
Nonetheless, CytoDyn, through Pourhassan, conveyed a much different message to the
investor public. For one, Pourhassan pushed through press releases and paid marketing videos that
touted Leronlimab’s supposed extraordinary results in treating those ill with COVID-19. 	On
December 22, 2020, for example, CytoDyn issued a press release claiming that the CD 10 trial
produced “statistically significant” positive results for treating COVID-19 based on the post hoc
analyses, but omitted any mention of the trial having failed to meet its primary or secondary
endpoints. 	GX-64. 	Likewise, CytoDyn reported to the investor public overly optimistic
interpretations of the CD 12 data. ECF No. 294, Tr. Vol 10 at 45; PX-1614 at 2. In short order,
the FDA received a slew of requests for emergency individual use of Leronlimab, ECF No. 294,
Tr. Vol. 10 at 34–35, which prompted the FDA to become increasingly concerned that CytoDyn
had been misleading patients and physicians about the efficacy of the drug as a COVID-19
treatment. ECF No. 293, Tr. Vol. 9 at 281.
Pourhassan also propped up a rosy and misleading narrative about Leronlimab’s efficacy
in the company’s SEC filings. Attached to the annual SEC Form 8-k2, filed on March 8, 2021,
Pourhassan submitted a lengthy summary of the CD 12 trial results. The summary did not disclose
that the trial failed to meet primary and secondary endpoints. GX-5; ECF No. 292, Tr. Vol. 8 at
2 SEC filings are made available through the SEC’s EDGAR database, https://www.sec.gov/search-filings.
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142. 	But it did represent that based on the studies “there is a high likelihood that critically ill
COVID-19 patients may benefit from leronlimab added on to SoC treatments.” GX-5A at 9; ECF
No. 292, Tr. Vol. 8 at 142. Pourhassan also issued similar press releases that boasted about the
continued safety and efficacy of the drug for “severe-to-critical patients.” GX-71 (March 5, 2021),
GX-52 (March 30, 2021). Notable spikes in trading volume and price tracked these releases. GX-
902.
On May 17, 2021, the FDA, in response, posted to its website a public announcement that
the CD 10 and CD 12 trials “do not support the clinical benefit of leronlimab for the treatment of
COVID-19,” and that any benefit experienced within “small subgroups” had “well-established
limitations,” and so cannot be said to “show a benefit in the overall study population.” GX-636.
Despite this, Pourhassan continued to issue written and video statements praising the drug’s benefit
with severely ill COVID-19 patients. In one promotional video, Pourhassan announced that “this
product blows every scientist’s mind” and that he is “very happy with everything” related to
Leronlimab. GX-1A; GX-1B. Pourhassan particularly characterized the effect of Leronlimab on
COVID-19 patients as “nothing short of spectacular.” He explained,
It’ s going for critical population, mild population, long hauler. That’s three critical,
three, three COVID-19 trials that we are now very confident that we could hit
primary endpoint due to all the studies we have done.
GX-1A.
In another video posted on September 22, 2021, Pourhassan celebrated a trial “of 394
patients which included severe and critically ill population [and] [i]n the critically ill population,
our results were really strong . . . . the survival rate was 78%. Once we gave them another dose,
the survival rate went up to 82%.” GX-53A.
The FDA never approved Leronlimab for treatment of COVID-19 as to any population.
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C. The Indictment and Verdict
At trial, the jury had to decide fourteen criminal charges alleged in the forty-page speaking
Indictment. ECF No. 185.3 Thirty-two of the forty pages are devoted to Count 1, which charged
a factually dense, multi-year conspiracy between Kazempour and Pourhassan encompassing the
entirety of the alleged securities and wire frauds. 	Id. 	at 1–32. 	In Counts 2 through 5, the
Indictment charged substantive securities fraud as follows:
COUNT 	DATE 	INTERSTATE COMMUNICATION
2 	4/14/2020 	POURHASSAN sent the email to KAZEMPOUR and Amarex
Executive 1, as described in Paragraph 44 above.
3 	4/27/2020 	KAZEMPOUR 	and 	Amarex 	filed 	an 	incomplete 	BLA 	on
CytoDyn’s behalf with the FDA, as described in Paragraph 46
above.
4 	8/14/2020 	POURHASSAN and KAZEMPOUR caused CytoDyn to submit
its annual SEC filing on SEC Form 10-K, as described in
Paragraph 58 above.
5 	3/8/2021 	POURHASSAN and KAZEMPOUR caused CytoDyn to file an
SEC form 8-K as described in Paragraph 66 above.
ECF No. 185 at 33. Counts 6 through 10 charged multiple counts of wire fraud as follows:
COUNT 	DATE 	DEFENDANT 	INTERSTATE WIRE COMMUNICATION
6 	2/8/2020
12:33:43
PM
NADER
POURHASSAN
Electronic message from POURHASSAN
(x4173) to KAZEMPOUR (x0800) and Amarex
Executive 1 (x3264)
7 	4/14/2020 	NADER
POURHASSAN
E-mail from POURHASSAN to Amarex
Executive 1 and KAZEMPOUR, with cc to
CytoDyn Executive 2; Subject: “BLA
submission”
8 	4/28/2020 	KAZEM
KAZEMPOUR
E-mail from KAZEMPOUR to CytoDyn
Executive 3, with cc to POURHASSAN and
KAZEMPOUR’s financial advisor; Subject:
“CytoDyn: Proposed final press release for
regulatory approval”
9 	5/16/2020 	KAZEM
KAZEMPOUR
E-mail from KAZEMPOUR to CytoDyn
Executive 3, with cc to POURHASSAN and
3 Technically, the Defendants went to trial on a Superseding Indictment, but for brevity, the Court will refer to it as
the “Indictment” or the “charges.” ECF No. 185.
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KAZEMPOUR’s financial advisor; Subject: “the
warrant shares”
10 	2/23/2021 	NADER
POURHASSAN
Email from POURHASSAN to KAZEMPOUR,
and others, with the subject line “CytoDyn
Leronlimab D12 COVID-19 Executive Summary
Addendum FINAL,” instructing KAZEMPOUR
to submit the Addendum to the FDA
Id. at 35. 	The Indictment further charged solely Pourhassan with three insider trading
counts:
COUNT 	DATE 	TRANSACTION
11 	4/30/2020 	Sale of approximately 2.2 million shares of
CytoDyn stock valued at approximately $7.8
million
12 	5/1/2020 	Sale of approximately 1.39 million shares of
CytoDyn stock valued at approximately $4.5
million
13 	5/4/2020 	Sale of approximately 1.2 million shares of
CytoDyn stock valued at approximately $3.3
million
Id. at 37. Lastly, the Indictment alleged in Count 14 that Kazempour made materially false
statements to an FBI agent during a July 7, 2021 investigative interview based on Kazempour’s
telling the agent that he owned only a couple hundred shares of CytoDyn stock when, in fact, he
had possessed much more. Id. at 38.
After three weeks of testimony and five days of deliberation, the jury acquitted Pourhassan
and Kazempour of conspiracy (Count 1). 	As to Pourhassan, the jury convicted him on all
substantive securities fraud counts (Counts 2 through 5), two of the three wire fraud counts (Counts
7 & 10), and all three insider trading counts (Counts 11 through 13). ECF No. 280.
The verdict as to Kazempour, however, was the mirror opposite. The jury acquitted
Kazempour of all counts save for two: one count of securities fraud based on Kazempour’s April
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27, 2020 BLA submission (Count 3), and one count of wire fraud based on the April 28, 2020
email he sent about selling CytoDyn warrants (Count 8). ECF No. 282.
Defendants now move for judgment of acquittal on all counts pursuant to Federal Rule of
Criminal Procedure 29, or alternatively, for a new trial pursuant to Rule 33. The Court first turns
to the Rule 29 motions, discussing each Defendant separately.
III. 	Motions for Judgment of Acquittal
On a motion for judgment of acquittal, the Court may grant relief on the grounds of
insufficient evidence “if no rational trier of fact could have agreed with the jury.” Coleman v.
Johnson, 566 U.S. 650, 651 (2012) (quoting Cavazos v. Smith, 565 U.S. 1, 2 (2011)). 	When
assessing whether any rational juror could have convicted a defendant, the Court must view the
evidence in the light most favorable to the Government. United States v. Tresvant, 677 F.2d 1018,
1021 (4th Cir. 1982). The Court must allow the verdict to stand if, when drawing all inferences in
favor of the Government, “substantial evidence” nonetheless supports the conviction. 	United
States v. Burgos, 94 F.3d 849, 862 (4th Cir. 1996) (quoting Glasser v. United States, 315 U.S. 60,
80 (1942)). 	See also United States v. Mitchell, 177 F.3d 236, 240 (4th Cir. 1999) (reversing
judgment of acquittal, finding the “jury heard [defendant’s] version of the events and the
Government’s; it apparently believed the Government’s version.”). 	On a Rule 29 motion, the
Court may not pass on witness credibility and must assume that all factual contradictions were
resolved in favor of the Government. United States v. United Med. & Surgical Supply Corp., 989
F.2d 1390, 1402 (4th Cir. 1993).
With this standard in mind, the Court first turns to Kazempour’s motion.
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A. Kazempour
As to Count 3, the wire fraud count concerning the April 27, 2020 BLA submission,
Kazempour contends that no reasonable juror could have concluded he acted with the specific
intent to defraud because the FDA “already had in hand the datasets” and because nothing shows
that Kazempour personally ever reviewed or approved the April 27 press release touting the
completion of the BLA. ECF No. 311-1. The Court is not persuaded.
The critical question before the jury was whether Kazempour’s electronic submission of
the BLA, in concert with CytoDyn claiming the BLA to be “complete,” constituted a fraud on
CytoDyn investors. Simply because the FDA had the underlying data in some form did not make
the BLA “complete,” or so the jury could have concluded. The FDA also had clearly instructed
Kazempour and Pourhassan of the requirements for submitting a complete BLA, to include the
data that was formatted according to FDA specification. 	ECF No. 287, Tr. Vol. 3 at 153–54.
Equally relevant, the FDA told Defendants that the BLA review process only begins upon
submitting a complete BLA. Id. at 32, 34.
As a variation on that argument, Kazempour also presses that no reasonable juror could
have concluded that the omission of “reformatted datasets” mattered to the reasonable investor.
ECF No. 311-1 at 33. The jury was correctly instructed that “[f]or a fact to be considered material,
there must be a substantial likelihood that a reasonable investor would consider the fact important
in deciding whether to buy or sell the security or would have viewed the total mix of information
available to them to be significantly altered by disclosure of the fact.” ECF No. 264 at 30. 	To the
testifying investors, the completeness of the BLA did matter to them. See ECF No. 288, Tr. Vol.
4 at 154:15–20, 166:5–168:2 (Kang), 128:18–25 (Lonsford); ECF No. 287, Tr. Vol. 3 at 160:19–
161:3 (Horvath); ECF No. 290, Tr. Vol. 6 at 165:4–16 (Munves). Kazempour’s argument in this
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regard thus amounts to a disagreement with the verdict rather than a claim rooted in insufficient
evidence.
Kazempour also knew from Pourhassan that filing the BLA on April 27, “no matter what,
even if short,” was critical to maintaining the stock price. GX-119; GX-6; GX-30; GX-310H; GX-
2. From this, a reasonable juror could conclude that at a minimum, Kazempour aided and abetted
Pourhassan’s securities fraud by knowingly filing the BLA when it was not “complete” in the
sense that it did not comport with the FDA’s filing requirements.
Nor is it a fair inference from the evidence that Kazempour had been unaware of the
contents of the April 27 press release, at least that it was falsely communicating the BLA was
“complete” for purposes of FDA review. 	While Kazempour emphasizes that Dhody, not he,
reviewed the contents of the specific release, the evidence also showed that Kazempour and Dhody
communicated about the timing of the release and Dhody’s final approval of it. GX-34. This, in
combination with the evidence that Kazempour and Pourhassan were in constant communication
about the BLA, the contents of press releases, the issuance of the April 27 release, and the influence
it would likely have on the stock price, permit the reasonable inference that Kazempour knew the
press release would falsely state the BLA was complete when it was not. See ECF No. 292, Tr.
Vol. 8 at 62:21–63:2.
As to Count 8, securities fraud premised on Kazempour’s April 28 inquiry about selling
his warrants, Kazempour argues that he acted in “good faith.” ECF No. 311-1 at 23. But the jury
had been properly instructed on the defense of good faith and rejected its application. Given that
the evidence supports that he aided and abetted Pourhassan to mislead about the BLA just the day
before, a reasonable juror could conclude that Kazempour’s attempted exercise of the warrants the
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next day was for his own financial benefit, and thus reflected fraudulent intent to profit from an
artificially inflated stock price. Kazempour’s motion for judgment of acquittal is thus denied.
B. Pourhassan
Pourhassan advances four main arguments in favor of acquittal. 	Like Kazempour, he
contends that the Government “failed to negate the avalanche of evidence that he acted in good
faith,” thus warranting reversal on all counts of conviction. ECF No. 312-1 at 9–14. Second, he
contends that the Government failed to prove his “specific intent” to defraud as to the securities
and wire fraud counts. Id. at 11–15. Third, he claims that evidence on materiality of the alleged
false statements to the public is lacking because most statements were aspirational or “forward-
looking” and thus “not actionable as a matter of law.” Id. at 33–35. Fourth, Pourhassan contends
that investor witness testimony was insufficient to demonstrate the materiality of the statements
made to the investor public. Id. at 16–26. The Court takes each contention in turn.
To begin, the good faith argument fails because the jury had been properly instructed on
good faith and the Government’s ultimate burden to disprove the same. Pourhassan’s arguments
now amount to little more than selectively emphasizing favorable evidence while ignoring the
wealth of other evidence supporting guilt. 	For example, Pourhassan stresses that he personally
“believed” the BLA was “complete when filed.” ECF No. 312-1 at 11. Certainly, some evidence
supports that inference. 	But other evidence does not, such as his entreaty to “file the BLA . . .
even if we are short in no matter what portion of whatever it is that we are short”; this alone permits
a reasonable juror to draw an inference of guilt and reject claims of “good faith.” GX- 2.
Pourhassan similarly emphasizes Dhody’s testimony that Dhody viewed the BLA as
“complete” and thus found no impediment to characterizing the BLA as “complete.” 	ECF No.
296, Tr. Vol. 12 at 70:1–2, 75:10–17. At best, Dhody and other scientists supported Pourhassan’s
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counter narrative. 	But the jury also had FDA witnesses and contemporaneous documents
reflecting that from the perspective of the agency responsible for reviewing the BLA, the
application was decidedly not complete, and the Defendants knew it would not be considered
complete at the time they filed it. The jury simply resolved these evidentiary conflicts in favor of
guilt. See United States v. Dinkins, 691 F.3d 358, 387 (4th Cir. 2012).
As for the COVID-19 allegations, again Pourhassan stresses the evidence that points in
favor of his personal belief that Leronlimab was effective in battling COVID-19 and argues from
there that the statements to the investor public that the drug “saves lives” were made in good faith.
ECF No. 312-1 at 12. 	But this alone does not rebut the Government’s proof that Pourhassan
omitted from the SEC filings and press releases that the COVID-19 clinical trials failed to meet its
endpoints, or that the FDA would not grant an EUA. GX-630. The jury was entitled to, and did,
credit the solid counter evidence to Pourhassan’s belief in the drug’s efficacy.4
As to the “forward-looking” quality of certain statements, Pourhassan often did express
hope and optimism about the future of Leronlimab as a safe, effective treatment for HIV and
COVID-19. E.g., ECF No. 286, Tr. Vol. 2 at 220:12–221:25; ECF No. 287, Tr. Vol. 3 at 254:1–
15; ECF No. 290, Tr. Vol. 6 at 231:15–25. But not all statements were such. More to the point,
the jury had been plainly instructed that forward-looking statements could not form the basis of
the fraud charges. ECF No. 264 at 30 (Jury Instruction No. 39). Pourhassan was also given wide
latitude to develop the evidence and argue this as the very reason he was entitled to acquittal. Thus,
as with his good faith argument, that the jury disagreed does not support setting aside the verdict.
4 The “good faith” argument as to the insider trading counts suffers from the same flaws. ECF No. 312-1 at 13. The
Court gave Pourhassan ample runway to demonstrate that he exercised his options not for personal gain but to pay
CytoDyn’s debts. E.g., PX-961; ECF No. 292 at 176, 178–79. However, Pourhassan also netted significant personal
wealth from the stock sales and this, in combination with the remaining evidence, amply supports the convictions.
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Pourhassan’s last argument is in many ways the most vexing. 	He disagrees that the
materiality of the alleged false statements supporting the fraud counts had been sufficiently
established through four individual investor witnesses. ECF No. 312-1 at 25. He argues now, as
he did at trial, that the investors were not sufficiently sophisticated or had received stock advice
from unreliable sources, and he faults the Government for failing to use a more “systematic”
economic “event study” to tie the stock price movement to the alleged false statements. ECF No.
298, Tr. Vol. 14 at 203–04.
The jury, however, was correctly instructed on the materiality element. ECF No. 264 at
30. 	The jury also learned about the nature of the penny stock market of which CytoDyn was a
part, including its relatively riskier investment posture. ECF No. 286, Tr. Vol. 2 at 67–68, 71. The
jury further heard that the majority of CytoDyn investors were like the four witnesses in that they
were mostly retail investors, not corporate entities. ECF No. 292, Tr. Vol. 8 at 41:13–21. Last,
given that CytoDyn was a single drug, pre-revenue company, it is eminently logical that
submission of a complete BLA or the chance to obtain an EUA was material to investors. E.g.,
ECF No. 290, Tr. Vol. 6 at 165:4–16 (Munves testifying he reviewed the April 27 press release
the day it was released and having a completed BLA was “key” because “[y]ou can’t do anything
unless you have a complete – a completed BLA. Otherwise, you can’t get a BLA approval from
FDA.”); ECF No. 287, Tr. Vol. 3 at 181:24–182:5 (Horvath testifying “the press releases and the
information produced by CytoDyn was, you know, my only view into the company and whether I
should buy, sell, or hold on the stock itself.”). Thus, the Court cannot grant judgment of acquittal
on this basis.
The motions for judgment of acquittal are denied. 	The Court next turns to Defendants’
motions for new trial.
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IV. 	Motions for New Trial
Under Rule 33 the Court “should exercise its discretion to grant a new trial ‘sparingly,’ and
. . . should do so ‘only when the evidence weighs heavily against the verdict,’” United States v.
Perry, 335 F.3d 316, 320 (4th Cir. 2003) (quoting United States v. Wilson, 118 F.3d 228, 237 (4th
Cir. 1997)), or “when substantial prejudice has occurred,” United States v. Jones, 542 F.2d 186,
211 (4th Cir. 1976). 	Unlike a Rule 29 motion, here the Court considers the credibility of the
witnesses and assesses the evidence independently and holistically, “sitting as a thirteenth juror.”
United States v. Rafiekian, 68 F.4th 177, 186-87 (4th Cir. 2023) (quoting Tibbs v. Fla., 457 U.S.
31, 43 n.18 (1982)). See WRIGHT & M ILLER ’ S FEDERAL P RACTICE & P ROCEDURE § 582 (cataloging
the differences between the two standards). Where the jury’s verdict is split, the Court may infer
that the jury carefully considered the evidence against each defendant and based its verdict solely
upon that evidence. 	United States v. Cornell, 780 F.3d 616, 627 (4th Cir. 2015) (citing United
States v. West, 877 F.2d 281, 288 (4th Cir. 1989)). 	This inference, however, is not dispositive.
The Court, as the thirteenth juror, may reweigh the evidence and “properly conclude that a new
trial is warranted based on the cumulative weight of the evidence rather than by separately rejecting
each individual offer of proof by the government.” Rafiekian, 68 F.4th at 187 (internal citation
omitted).
A. Kazempour
Kazempour advances three arguments for a new trial, two of which can be easily disposed.
Kazempour contends that he should be retried because the Court erred in admitting a June 2021
email in which he tells members of Amarex’s parent company, NSF, that Pourhassan had directed
him to file the BLA “even if we are short.” See GX 167. Kazempour explains in the email that
the Amarex team had communicated to Pourhassan the “issues” with filing the BLA at that
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juncture, and Pourhassan told Kazempour to “do it regardless!” 	Id. 	The Court admitted the
document as a statement of a party opponent speaking directly to his knowledge and intent, having
worked in concert to file the BLA “even if we are short.” Id. Kazempour resurrects his objection
from trial and now insists that its admission warrants a new trial. The Court disagrees.
Notably, unlike Pourhassan, Kazempour was acquitted of the substantive fraud count
connected to the “even if short” email, so the jury did not ascribe it much weight as to him. But
more to the point, it is relevant and highly probative of the Defendants’ concerted activity to
knowingly file a BLA that was likely to be rejected by the FDA. Given the overwhelming evidence
reflecting Pourhassan’s obsession with inflating the stock price and his communication of the same
to Kazempour, the Court cannot credit that the email was “irrelevant” and unduly prejudicial
warranting a new trial.
Kazempour also argues that this Court should grant a new trial because the Government’s
reference in closing to the FDA’s opinion carrying more weight than other experts in the field on
the efficacy of Leronlimab had been so prejudicial as to deprive Kazempour of a fair trial. The
jury verdict says otherwise. 	See ECF No. 298, Tr. Vol. 14 at 170:2–172:12. 	Kazempour was
acquitted of conspiracy and all fraud related to the COVID-19 trials. The Court also immediately
gave the jury a curative instruction, reminding them that the FDA is to be accorded no special
weight regarding its scientific opinions. 	ECF No. 298, Tr. Vol. 14 at 179:16–180:7. 	The jury
presumptively followed these instructions. 	See United States v. Zelaya, 908 F.3d 920, 930 (4th
Cir. 2018); United States v. Johnson, 587 F.3d 625, 633 (4th Cir. 2009). Defendants also presented
ample evidence and testimony that called into question the soundness of the FDA’s views on the
efficacy of Leronlimab.5 Thus, the Court will not award Kazempour a new trial on this basis.
5 E.g., testimony of Dr. Alice Chen (expert opining on validity of post hoc analyses). ECF No. 296, Tr. Vol. 12 at
19:5–24:23.
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Kazempour’s strongest argument, however, carries the day. Looking to the two counts of
conviction—the April 27 BLA submission and his query about selling CytoDyn stock the next
day—Kazempour contends that a joint trial with Pourhassan unfairly confused the jury and
prejudiced Kazempour such that the jury likely convicted him on an insider trading theory, even
though he had not been charged with insider trading. The Court agrees.
Insider trading is a form of securities fraud. United States v. O’Hagan, 521 U.S. 642, 652
(1997). 	But it is distinct from other liability theories of fraud which is why the Government
charges insider trading separately. See Securities Exchange Act of 1934 § 10, 15 U.S.C. § 78j(b);
O’Hagan, 521 U.S. at 652–53 (explaining the “traditional” and “classical” theories of insider
trading). 	To convict a defendant of insider trading, the Government must prove beyond a
reasonable doubt that the defendant (usually a corporate insider), who occupies a position of trust
with the publicly traded company, bought or sold stock to his advantage based on the possession
of material non-public information about the company. O’Hagan, 521 U.S. at 652 (“The classical
theory [of insider trading] applies not only to officers, directors, and other permanent insiders of a
corporation, but also to attorneys, accountants, consultants, and others who temporarily become
fiduciaries of a corporation.”). 	See also United States v. Corbin, 729 F. Supp. 2d 607, 613–14
(S.D.N.Y. 2010).
Particular to Kazempour, the Government acknowledged early on that it was not pursuing
an insider trading case against him, only Pourhassan. E.g., ECF No. 166 at 176, 196–97. And yet
throughout the trial, the Government pressed the “insider trading” theory of guilt, inviting the
confusion. In opening statement, the Government called Kazempour “an insider himself.” ECF
No. 286, Tr. Vol. 2 at 19:21, lumped Kazempour and Pourhassan together as both selling stock
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“on their own lie,” and emphasized the “money the defendants made” from deceiving the investor
public, id. at 20:21–22. The Government promised the jury:
You’ll see from an FBI forensic accountant how both defendants sold their shares
after the BLA announcement; Pourhassan immediately, even before any corrective
statement had been issued, and Kazempour a little later, but not for lack of trying.
And you’ll see the money they made from this lie: 4.4 million for Pourhassan and
more than 300,000 for Kazempour.
Id. at 20:10–15 (emphasis added).
Then—after having just referred to Kazempour as a CytoDyn “insider,” the Government
elicited from its first witness the following:
Q. What are the limits to when an insider at a public company can sell stock in
their own company?
A. Insiders are not permitted to sell—buy or sell stock when they are—when they
have what’s known as material nonpublic information about a company—about
their company.
Q. And material nonpublic information, is that just any information that executives
know or is it a specific category of information?
A. Well, it’s the type of information that a reasonable investor would find to be
important when they are making their decision as to whether they are going to buy
or sell the stock. It’s a component where an investor would find it compelling when
they’re considering the total mix of information that's out there about the company.
Id. at 87:1–11.
The Government next put before the jury robust testimony supporting the Government’s
“insider” theory as to Kazempour. 	Former CytoDyn officer, Anthony Caracciolo, described
Kazempour as CytoDyn’s “regulatory officer,” and one of the CytoDyn “staff” because he had
been regularly involved in staff and board meetings. ECF No. 288, Tr. Vol 4 at 103:19, 44:1–9.
CytoDyn’s CFO, Mulholland, too referred to Kazempour as essentially the only “formally
appointed agent” between CytoDyn and the FDA, causing CytoDyn to “place reliance on Dr.
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Kazempour to have the best most current information available with respect to” the FDA. ECF
No. 292, Tr. Vol. 8 at 71:15–23.
Then, in closing, the Government drove the point home. 	They called Kazempour a
“member of the [CytoDyn] staff,” ECF No. 298, Tr. Vol. 14 at 135:11–13, and that “[n]o one else
had that level of access” into the company’s goals of taking the drug to market and the FDA, id.
at 135:19. The Government particularly stressed that Kazempour was “paid” in stock and so “if
the stock price was to go up, he would profit from that.” Id. at 136:1–6. And that “because of Dr.
Kazempour’s unique role in the company . . . he had that financial interest—in CytoDyn.” Id. at
136:7–11. See also id. at 139:8–10 (“[E]ven though Dr. Kazempour is not part of the company,
he’s like part of the company.”).6 Indeed, the Government highlighted how “important” it is for
the jury to “note” that Kazempour “sells [his stock] before the refuse-to-file is issued. He sells
before the market becomes aware of the information that he knows, and his staff knows, which is
that they don’t have the thing that they need to make the BLA complete.” Id. at 147:11–12. See
also id. at 149:15–18 (“This really tells you all you need to know about [Kazempour’s] intent.
He’s focused on selling his shares. And this is at a time when the public still does not know that
the BLA is so incomplete that there will probably be filing issues.”) (emphasis added).
Indeed, the confusion was compounded by the Government’s choice to pursue a similar
“insider” theory of liability against Kazempour on the securities fraud counts for which he was
charged. 	E.g., ECF No. 73 at 10:21–22 (Government acknowledging its “fox-in-the-henhouse”
liability theory as to Kazempour); id. at 11:11–12 (Government counsel arguing that Kazempour
sells his stock “while he’s in possession of material, nonpublic information”). 	This is because
6 The Government also emphasized that Kazempour’s efforts to place stock in his wife’s name was a badge of fraud
because Kazempour had known at the time he filed the BLA it was not complete, and the consequent rise in stock
price was his “motive” to participate in the conspiracy. ECF No 298, Tr. Vol. at 149:7–8.
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Kazempour, as a contractor of CytoDyn, did not automatically possess the same fiduciary duties
to CytoDyn as Pourhassan. 	Accordingly, the question of Kazempour’s “duty” to correct false
CytoDyn press releases or ensure that the releases were factually accurate had been a hotly
contested matter throughout. 	See id.; see also ECF No. 197 at 192:2–199:23, 207:2–23.
Nonetheless, the Government chose to press that liability theory (as opposed to the less
controversial aiding and abetting theory) which is the Government’s prerogative. But the Court
cannot ignore how that choice likely led to significant confusion as to the basis on which
Kazempour was convicted.
Perhaps the susceptibility for confusion is best captured by comparing insider trading
instructions pertinent only for Pourhassan, and the securities fraud instructions for Kazempour.
They are almost identical. For the non-insider trading counts, the jury was told that as to “duty”
they must consider whether Kazempour “had a duty to CytoDyn shareholders to disclose material
facts,” to include whether he “had another position of trust or confidence within the corporation
giving rise to such a duty. In this regard an officer or director of a corporation owes a special duty
of trust and confidence to its shareholders.” 	ECF No. 264 at 30 (Jury Instruction No. 40)
(emphasis added). See also id. at 31 (Jury Instruction No. 41 on the Duty to Correct a Material
Fact). Likewise, for Pourhassan’s insider trading counts, the jury was instructed, that “an insider
is one who comes into possession of material, confidential, non-public information about a stock
by virtue of a relationship that involves trust and confidence.” Id. at 67–68 (Jury Instruction No.
60) (emphasis added). Further, the jury was told that a person is “forbidden to buy or sell securities
of a company if the Government establishes that he had assumed a special confidential
relationship affording him access to material confidential information intended to be available
only for a corporate purpose and not for his personal benefit.” See id. at 68 (Jury Instruction No.
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60) (emphasis added). This confusion could have been avoided were Kazempour and Pourhassan
tried separately. The jury also would not have heard the robust evidence about insider trading as
to Pourhassan which bore no relevance to the counts as to Kazempour. But because the Defendants
were tried together, it is hard to imagine how the jury compartmentalized the strong evidence
supporting the insider trading conviction of Pourhassan separate from Kazempour.
The risk that Kazempour’s verdict suffered from unfair, prejudicial spillover is even greater
when considering that the evidence against Kazempour was otherwise thin. 	Kazempour was
acquitted of all other wrongdoing—conspiracy to commit securities and wire fraud writ large; the
COVID-19 scheme; and even making false statements to the FBI agents about the number of shares
he owned. 	Under these circumstances, the Court is deeply concerned that the jury mistakenly
engrafted onto Kazempour the “insider trading” theory and evidence meant only for Pourhassan.
The Government responds with valid points. 	Most persuasively, they argue that a jury,
especially one that deliberated for five days and issued split verdicts as to both Defendants, is
presumed to have followed the Court’s instruction and delivered a constitutionally sound verdict.
ECF No. 371 at 17. The Government equally emphasizes that a jury verdict remains inviolate and
to be overturned only in the most extraordinary of circumstances. Id. at 7. The Court agrees with
these fundamental principles. 	But they do not eclipse the unfairness in allowing Kazempour’s
verdict to stand.7 Because of this, the Court concludes that Kazempour is entitled to a new trial
on Counts 3 and 8 so that the jury may fairly assess the weight of the evidence against Kazempour
free of prejudicial spillover.
7 The Government also wrongly argues that Kazempour did not raise during pretrial the likelihood of prejudicial
spillover from Pourhassan’s insider trading charges. ECF No. 371 at 27. He did. ECF No. 61 at 6, 10, 15. See also
ECF No. 166 at 196 (raising confusing question of insider “duty” as to Kazempour when he is not charged with insider
trading). In fact, the Court entertained extensive argument on the confusion animating the Government’s charging
choices on the question of duty, particularly on the multiple alternate liability theories it could have pursued against
Kazempour. ECF No. 166 at 202–04; see also id. 204:19–20 (Government admitting that “duty is one of the three
ways in which we can prove the substantive securities fraud count” as to Kazempour).
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B. Pourhassan’s Motion for New Trial
Pourhassan essentially filed two motions for new trial. 	In the first, he urges that for the
same reasons he was entitled to judgment of acquittal, he should receive a new trial. 	ECF No.
312-1 at 35–36. The Court rejects those arguments for the same reasons already discussed.
After a hearing on these motions, Pourhassan sought leave to supplement his Rule 33
motion to address exclusively that if the Court grants Kazempour a new trial, Pourhassan ought in
fairness receive a do-over as well. The Court also rejects that argument for the following reasons.
Pourhassan primarily argues that he should be awarded a new trial because he would have
made different strategic decisions had he stood trial alone. Chief among them is that he “may well
have” testified in his own defense. ECF No. 370 at 3. This bald, self-serving proposition is a non-
starter. Unlike Kazempour, the evidence against Pourhassan was substantial. 	Without a
particularized showing as to how Pourhassan’s right to testify was not only encumbered but
prejudicially so, a new trial is not warranted.
Pourhassan next contends that Kazempour acted as a “second prosecutor” by shifting the
blame away from himself and onto Pourhassan. ECF No. 370 at 3. As a matter of law, antagonistic
defenses alone do not warrant severance, and by extension, do not support a new trial. See Dinkins,
691 F.3d at 369 (“Hostility among defendants, and even a defendant’s desire to exculpate himself
by inculpating others, do not of themselves qualify as sufficient grounds to require separate
trials.”). 	But even if it did, the defenses here were simply not antagonistic. 	Sure, Pourhassan
blamed Amarex, and Kazempour as the regulatory expert, for misadvising him about the status of
the BLA and the efficacy of Leronlimab as to COVID-19. 	ECF No. 286, Tr. Vol. 2 at 30:23–
31:12, 35:20–23 (opening statement); ECF No. 287, Tr. Vol 3 at 106 (cross of Kimberly Struble,
FDA witness); ECF No. 295, Tr. Vol. 11 at 22 (direct of Dr. Mark Robbins, defense regulatory
expert). Defense expert, Dr. Mark Robbins, particularly discussed why companies like CytoDyn
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rely on companies like Amarex for specific knowledge and expertise. ECF No. 295, Tr. Vol. 11
at 31:9–16 (Q: Dr. Robbins, do pharmaceutical companies navigate the drug development process
alone? A: No. Pharmaceutical companies always use experts that help navigate the process. . . .
With small pharmaceutical companies, you’re much more dependent upon getting outside
resources.”). See also id. at 32–35. He also emphasized why regulatory agents such as Kazempour
are essential to the licensing process in that they are the subject matter experts in shepherding the
company through FDA licensure. Id. at 35–45. In closing, Pourhassan focused the jury on this
theory: Pourhassan “relied on the experts that he hired and held accountable for their advice.” ECF
No. 298, Tr. Vol. 14 at 181:7–9.
Kazempour’s defense, by contrast, emphasized that neither he nor Pourhassan were guilty
of fraud at all. E.g., ECF No. 298, Tr. Vol. 14 at 233:5–7 (arguing that the April 14 email from
Pourhassan triggered Amarex to “work really hard to finish” the BLA); id. at 233:13–17 (Amarex
employees testifying they didn’t think there was “anything wrong” with submitting the BLA absent
reformatted datasets); id. at 237:4–5 (Kazempour arguing “whatever you think about” the April 27
BLA, “it had been fixed by May 11th”). Kazempour also stressed an equally Pourhassan-friendly
theme that the FDA reviewers were deeply biased against CytoDyn and so were never going to
approve Leronlimab as a therapeutic. 	Id. at 238:7–9. 	Pourhassan further benefitted from
Kazempour’s expert witness who opined that Leronlimab helped some patients even if the primary
endpoints of the trials had not been met. See ECF No. 296, Tr. Vol 12 at 15 (testimony of expert
Dr. Alice Chen). See also ECF No. 298, Tr. Vol. 14 at 243:6–7 (“Alice Chen told you that, when
the FDA said that the COVID-19 clinical trials showed no benefit, the FDA was wrong.”). Thus,
Pourhassan’s “second prosecutor” theory bears little relationship to what happened at trial.
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In the end, the asymmetry of evidence—strong as to Pourhassan, far less so to
Kazempour—combined 	with 	the 	Government’s 	prosecutorial 	choices, 	rendered 	the 	trial
fundamentally unfair as to one but not the other. Pourhassan’s new trial motion is DENIED.
IV. 	Conclusion
For the reasons stated above, Defendant Kazem Kazempour’s motion for judgment of
acquittal is DENIED but his motion for new trial is GRANTED. Defendant Nader Pourhassan’s
motions for acquittal and new trial are DENIED. A separate Order follows.
Date: 	January 16, 2026 	_______________________
PAULA XINIS
United States District Judge
/s/
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