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Posted On: 04/20/2024 8:32:34 PM
Post# of 148878
U.S. Department of Justice
Criminal Division
Re: United States v. Pourhassan, Criminal No. PX-22-440
Dear Counsel:
The government writes in response to (i) defendant Kazem Kazempour’s letter dated April
2, 2024 (the “Kazempour Letter”), and (ii) defendant Nader Pourhassan’s letter dated April 3, 2024
(the “Pourhassan Letter”), demanding that the Department of Justice team prosecuting the case
conduct a full file review of all FDA employees involved in the HIV BLA submission and expand
the parameters of the FDA’s search for records related to COVID-19. The defendants’ letters
make plain they are attempting to use discovery in this criminal case as a tool to relitigate issues
from their civil dispute, namely CytoDyn, Inc. v. Amarex Clinical Research, LLC, et al., Civil No.
21-2533 (D. Md.). For years the defendants fought over the “true” reasons the FDA did not approve leronlimab and who was to blame. While the defendants zealously seek this information, it is irrelevant to the issues in this case and an abuse of criminaldiscovery. The questions to be presented at trial concern (i) what the FDA communicated to the defendants with respect to the HIV BLA submission and the COVID-19 clinical results, and (ii) what, in turn, the defendants did
in response to, or with, the information that the FDA had communicated to them. For these and the other reasons set forth below, the government opposes the defendants’ latest set of demands.
I. At Trial, the Government Will Establish Knowledge and Intent Based on Uncontrovertible Evidence of What the FDA Told the Defendants As Kazempour’s Letter states, “the indictment alleges that the defendants submitted the BLA to the FDA knowing that it was deficient and that the FDA would refuse to file it.” Kazempour Letter at 2. And as Dr. Kazempour’s counsel has acknowledged, “the central question is what did these defendants know when this BLA was submitted?” Hearing Tr. 61:8-9, Oct. 13,
2023.
At trial, the government intends to introduce evidence showing that the defendants
submitted the BLA to the FDA knowing that it was incomplete, and did so with knowledge that the FDA would deem it incomplete and refuse to file it, so that CytoDyn could issue a press release announcing that it had surpassed a regulatory milestone when, in truth, it had not. The deceptive
purpose of filing the incomplete BLA was to artificially inflate CytoDyn’s stock price, among other things.
In order to establish the defendants’ knowledge and intent, the government will introduce the FDA records identified on the government’s exhibit list, which includes correspondence and meeting minutes showing that the defendants knew – because FDA repeatedly told them – that (i) the BLA was not complete without final datasets and dose justification analysis, (ii) the FDA would not review an incomplete BLA, and (iii) an incomplete BLA was a refuse to file issue. The government’s witness list provided notice of its intent to call three potential witnesses from the FDA - Sam Skariah, Suzanne Strayhorn, and Virginia Sheikh.
In addition, the government will introduce communications between the defendants and their employees showing that the defendants knew the BLA was incomplete and understood that there were risks associated with submitting an incomplete BLA because the FDA would not review the submission and likely would refuse to file it.
The government also intends to introduce Dr. Kazempour’s sworn declaration, filed on
October 26, 2021, in CytoDyn v. Amarex Clinical Research LLC, et al. (D. Md.) (Judge Peter J. Messitte), in which he swore under oath that “a refusal to file” for “missing and incomplete information” was “not surprising” and “exactly what was to be expected.” In his signed
declaration, Dr. Kazempour stated under penalty of perjury:
Dr. Nader Pourhassan wrongly attempts to blame Amarex for CytoDyn’s own issues, this
time for the FDA’s rejection of CytoDyn’s Biological License Application for HIV treatment (the “BLA”). In actuality, the FDA rejected CytoDyn’s BLA because Dr. Pourhassan directed Amarex to file the BLA prematurely, knowing it was incomplete, lacking in appropriate content, and not ready for submission. Dr. Pourhassan was warned of the issue repeatedly.
Dr. Pourhassan sent the following affirmative directions to Amarex: “Please 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.” See Ex. C, April 14, 2020 email from Nader Pourhassan to Amarex. His justification for his premature direction, as stated in his email, stems from a stock price drop and to allay “investors who are very frustrated with me and CytoDyn.”
At Dr. Pourhassan’s direction, Amarex submitted the incomplete and lacking BLA to the FDA. Not surprisingly, the FDA rejected the filing and refused to file it because the
“application does not contain all the pertinent information and data needed to complete a substantive review.” Ex D, FDA Refusal to File Letter dated July 8, 2020.
Dr. Pourhassan and CytoDyn received exactly what was to be expected, a refusal to file for missing and incomplete information or, as Dr. Pourhassan put it:
“even if we are short in no matter what portion of whatever it is that we are short.”
II. Kazempour’s Present Day Defense Directly Contradicts What He Previously Told
a Different Federal Judge in This Same Courthouse Under Penalty of Perjury With the benefit of time, it has become clear that Kazempour’s representations to Judge
Paula Xinis in 2023 and 2024 – and what he plans to represent to the jury at trial – directly contradict what he told Judge Peter J. Messitte in this same courthouse in 2021.
For example, in defendant Kazempour’s October 30, 2023 letter to Judge Xinis, counsel
wrote:
At trial, Dr. Kazempour anticipates arguing that (a) he and others at Amarex believed that the FDA would accept the BLA and were surprised when the FDA refused to file the
application and (b) that the FDA refused the application in part out of animus towards
CytoDyn and Pourhassan.
Similarly, in defendant Kazempour’s April 2, 2024 letter, counsel wrote:
The indictment alleges that Dr. Kazempour submitted the BLA to the FDA knowing that
it was deficient and that the FDA would refuse to file it. But, as Dr. Kazempour will prove at trial, neither he nor others at Amarex believed that the FDA would reject the
application. He instead reasonably believed that, to the extent there were any deficiencies in the BLA, the FDA would follow its protocol and send requests for additional information, rather than outright reject the application. To Dr. Kazempour’s surprise, the
FDA did not follow that protocol but instead rejected the application without first
seeking additional information.
The government is concerned that the fundamental premise of Dr. Kazempour’s defense
today – that he was surprised that the FDA rejected the incomplete BLA – appears to be a misrepresentation of fact about his then-state of mind that is directly contradicted by sworn statements that Dr. Kazempour previously made before a different judge in this same courthouse under penalty of perjury. The government is comfortable that the steps it has taken thus far are consistent with Judge Xinis’s orders and provides the information that Dr. Kazempour requested.
The government, however, rejects Dr. Kazempour’s efforts to go beyond the agreed upon scope because there is no factual foundation to support Dr. Kazempour’s claim for further relief.
III. The Internal FDA Communications Cited in the Kazempour Letter Are Not Exculpatory
The government reiterates the position it has taken all along with respect to the FDA’s
internal communications. FDA employees’ views regarding the substance of the BLA and their reasons for refusing to file – about which the defendants had no knowledge – are not a defense to the charged conduct. To the extent the government is calling FDA witnesses to testify at trial, their prior statements and views about the defendants may be appropriate grounds for cross- examination, but they are not exculpatory as to the defendants’ knowledge and intent.
In fact, the FDA communications referenced in Dr. Kazempour’s April 2, 2024 letter are
entirely consistent with the facts alleged in the indictment. These communications do not demonstrate the FDA employees’ personal “animus” – i.e., hostility or ill feelings.
Rather, these
communications evidence the FDA employee’s shock at the defendants’ extraordinary and
egregious conduct. The communications show the FDA’s serious concerns about the truthfulness
and reliability of the information that the defendants’ provided to the public. See e.g., Kazempour
Letter, Ex. K.
Indeed, after the full production of FDA documents is complete, the Government
plans to provide an updated Exhibit List adding some of these newly-obtained documents to its
case in chief.
The Kazempour Letter states that the internal communications confirm that “the FDA had essentially moved the goalpost for the BLA.” Id. at 2. There is no factual support for this claim.
As described in the tables below, nine of the eleven communications counsel identified have no content related to the BLA. Id., Exs. A-F, H-I, K.
The two emails that do relate to the BLA, are not exculpatory, or even favorable, to the defendants. We have attached the same email chains as Government Exhibit 3 to this letter,
highlighting other sections that provide important context, as described below:
______
It then lists certain documents.
Did this to try timeling for attempted clarity & in case access has expired for some of us or can't access. Alot of outsiders read here.
These are thanks to StinkyPennies & so many others who have posted links to court docs.
Absolutelty outstanding & appreciated.
Criminal Division
Re: United States v. Pourhassan, Criminal No. PX-22-440
Dear Counsel:
The government writes in response to (i) defendant Kazem Kazempour’s letter dated April
2, 2024 (the “Kazempour Letter”), and (ii) defendant Nader Pourhassan’s letter dated April 3, 2024
(the “Pourhassan Letter”), demanding that the Department of Justice team prosecuting the case
conduct a full file review of all FDA employees involved in the HIV BLA submission and expand
the parameters of the FDA’s search for records related to COVID-19. The defendants’ letters
make plain they are attempting to use discovery in this criminal case as a tool to relitigate issues
from their civil dispute, namely CytoDyn, Inc. v. Amarex Clinical Research, LLC, et al., Civil No.
21-2533 (D. Md.). For years the defendants fought over the “true” reasons the FDA did not approve leronlimab and who was to blame. While the defendants zealously seek this information, it is irrelevant to the issues in this case and an abuse of criminaldiscovery. The questions to be presented at trial concern (i) what the FDA communicated to the defendants with respect to the HIV BLA submission and the COVID-19 clinical results, and (ii) what, in turn, the defendants did
in response to, or with, the information that the FDA had communicated to them. For these and the other reasons set forth below, the government opposes the defendants’ latest set of demands.
I. At Trial, the Government Will Establish Knowledge and Intent Based on Uncontrovertible Evidence of What the FDA Told the Defendants As Kazempour’s Letter states, “the indictment alleges that the defendants submitted the BLA to the FDA knowing that it was deficient and that the FDA would refuse to file it.” Kazempour Letter at 2. And as Dr. Kazempour’s counsel has acknowledged, “the central question is what did these defendants know when this BLA was submitted?” Hearing Tr. 61:8-9, Oct. 13,
2023.
At trial, the government intends to introduce evidence showing that the defendants
submitted the BLA to the FDA knowing that it was incomplete, and did so with knowledge that the FDA would deem it incomplete and refuse to file it, so that CytoDyn could issue a press release announcing that it had surpassed a regulatory milestone when, in truth, it had not. The deceptive
purpose of filing the incomplete BLA was to artificially inflate CytoDyn’s stock price, among other things.
In order to establish the defendants’ knowledge and intent, the government will introduce the FDA records identified on the government’s exhibit list, which includes correspondence and meeting minutes showing that the defendants knew – because FDA repeatedly told them – that (i) the BLA was not complete without final datasets and dose justification analysis, (ii) the FDA would not review an incomplete BLA, and (iii) an incomplete BLA was a refuse to file issue. The government’s witness list provided notice of its intent to call three potential witnesses from the FDA - Sam Skariah, Suzanne Strayhorn, and Virginia Sheikh.
In addition, the government will introduce communications between the defendants and their employees showing that the defendants knew the BLA was incomplete and understood that there were risks associated with submitting an incomplete BLA because the FDA would not review the submission and likely would refuse to file it.
The government also intends to introduce Dr. Kazempour’s sworn declaration, filed on
October 26, 2021, in CytoDyn v. Amarex Clinical Research LLC, et al. (D. Md.) (Judge Peter J. Messitte), in which he swore under oath that “a refusal to file” for “missing and incomplete information” was “not surprising” and “exactly what was to be expected.” In his signed
declaration, Dr. Kazempour stated under penalty of perjury:
Dr. Nader Pourhassan wrongly attempts to blame Amarex for CytoDyn’s own issues, this
time for the FDA’s rejection of CytoDyn’s Biological License Application for HIV treatment (the “BLA”). In actuality, the FDA rejected CytoDyn’s BLA because Dr. Pourhassan directed Amarex to file the BLA prematurely, knowing it was incomplete, lacking in appropriate content, and not ready for submission. Dr. Pourhassan was warned of the issue repeatedly.
Dr. Pourhassan sent the following affirmative directions to Amarex: “Please 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.” See Ex. C, April 14, 2020 email from Nader Pourhassan to Amarex. His justification for his premature direction, as stated in his email, stems from a stock price drop and to allay “investors who are very frustrated with me and CytoDyn.”
At Dr. Pourhassan’s direction, Amarex submitted the incomplete and lacking BLA to the FDA. Not surprisingly, the FDA rejected the filing and refused to file it because the
“application does not contain all the pertinent information and data needed to complete a substantive review.” Ex D, FDA Refusal to File Letter dated July 8, 2020.
Dr. Pourhassan and CytoDyn received exactly what was to be expected, a refusal to file for missing and incomplete information or, as Dr. Pourhassan put it:
“even if we are short in no matter what portion of whatever it is that we are short.”
II. Kazempour’s Present Day Defense Directly Contradicts What He Previously Told
a Different Federal Judge in This Same Courthouse Under Penalty of Perjury With the benefit of time, it has become clear that Kazempour’s representations to Judge
Paula Xinis in 2023 and 2024 – and what he plans to represent to the jury at trial – directly contradict what he told Judge Peter J. Messitte in this same courthouse in 2021.
For example, in defendant Kazempour’s October 30, 2023 letter to Judge Xinis, counsel
wrote:
At trial, Dr. Kazempour anticipates arguing that (a) he and others at Amarex believed that the FDA would accept the BLA and were surprised when the FDA refused to file the
application and (b) that the FDA refused the application in part out of animus towards
CytoDyn and Pourhassan.
Similarly, in defendant Kazempour’s April 2, 2024 letter, counsel wrote:
The indictment alleges that Dr. Kazempour submitted the BLA to the FDA knowing that
it was deficient and that the FDA would refuse to file it. But, as Dr. Kazempour will prove at trial, neither he nor others at Amarex believed that the FDA would reject the
application. He instead reasonably believed that, to the extent there were any deficiencies in the BLA, the FDA would follow its protocol and send requests for additional information, rather than outright reject the application. To Dr. Kazempour’s surprise, the
FDA did not follow that protocol but instead rejected the application without first
seeking additional information.
The government is concerned that the fundamental premise of Dr. Kazempour’s defense
today – that he was surprised that the FDA rejected the incomplete BLA – appears to be a misrepresentation of fact about his then-state of mind that is directly contradicted by sworn statements that Dr. Kazempour previously made before a different judge in this same courthouse under penalty of perjury. The government is comfortable that the steps it has taken thus far are consistent with Judge Xinis’s orders and provides the information that Dr. Kazempour requested.
The government, however, rejects Dr. Kazempour’s efforts to go beyond the agreed upon scope because there is no factual foundation to support Dr. Kazempour’s claim for further relief.
III. The Internal FDA Communications Cited in the Kazempour Letter Are Not Exculpatory
The government reiterates the position it has taken all along with respect to the FDA’s
internal communications. FDA employees’ views regarding the substance of the BLA and their reasons for refusing to file – about which the defendants had no knowledge – are not a defense to the charged conduct. To the extent the government is calling FDA witnesses to testify at trial, their prior statements and views about the defendants may be appropriate grounds for cross- examination, but they are not exculpatory as to the defendants’ knowledge and intent.
In fact, the FDA communications referenced in Dr. Kazempour’s April 2, 2024 letter are
entirely consistent with the facts alleged in the indictment. These communications do not demonstrate the FDA employees’ personal “animus” – i.e., hostility or ill feelings.
Rather, these
communications evidence the FDA employee’s shock at the defendants’ extraordinary and
egregious conduct. The communications show the FDA’s serious concerns about the truthfulness
and reliability of the information that the defendants’ provided to the public. See e.g., Kazempour
Letter, Ex. K.
Indeed, after the full production of FDA documents is complete, the Government
plans to provide an updated Exhibit List adding some of these newly-obtained documents to its
case in chief.
The Kazempour Letter states that the internal communications confirm that “the FDA had essentially moved the goalpost for the BLA.” Id. at 2. There is no factual support for this claim.
As described in the tables below, nine of the eleven communications counsel identified have no content related to the BLA. Id., Exs. A-F, H-I, K.
The two emails that do relate to the BLA, are not exculpatory, or even favorable, to the defendants. We have attached the same email chains as Government Exhibit 3 to this letter,
highlighting other sections that provide important context, as described below:
______
It then lists certain documents.
Did this to try timeling for attempted clarity & in case access has expired for some of us or can't access. Alot of outsiders read here.
These are thanks to StinkyPennies & so many others who have posted links to court docs.
Absolutelty outstanding & appreciated.
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