It's not all black and white, I'm curious about th
Post# of 154852
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Posted On: 09/22/2023 2:49:55 AM
It's not all black and white, I'm curious about the outcome.
Pages 9-10:
"In the April 14, 2020 e-mail
that the Government relies on, Dr. Pourhassan wrote, “Please file the BLA no later than next
Wednesday, even if we are short in no matter what portion of whatever it is that we are short.”
Indictment ¶ 37. The Government fails to explain how an out-of-context e-mail to Amarex that
“the BLA should be filed even if it was ‘short,’” equates to Dr. Pourhassan instructing Amarex to
file an “incomplete” BLA. (...)
In fact, the BLA was filed on April 27, 2020 (Indictment ¶ 38)—two weeks after the April
14, 2020 e-mail from Dr. Pourhassan—certainly not the following “Wednesday” as Dr. Pourhassan wrote
Second, the Government alleges that Dr. Pourhassan “falsely claimed . . . that CytoDyn
had submitted a ‘completed’ BLA when he know [sic] that it had not” (Opposition at 29;
Indictment ¶¶ 16, 39-40) but omits the important fact that CytoDyn’s press release and investor
call was held on April 27, 2020. Indeed, according to the Indictment and Opposition, this press
release and investor call both occurred three days before April 30, 2020 when the Indictment
alleges that Dr. Pourhassan received from Amarex the FDA e-mail stating that the BLA was
incomplete. Indictment ¶ 42. (...)
Additionally, CytoDyn’s corrective disclosures in May 2020 following the filing of the
BLA, negate, rather than support, a finding of fraudulent intent. Motion to Dismiss at 9. The
Government alleges that CytoDyn’s press releases in May 2020 “falsely claimed that a complete
BLA had been submitted, knowing that CytoDyn did not possess the necessary data to complete
the BLA.” Opposition at 29; Indictment ¶¶ 45-48. To the contrary, these corrective disclosures
clarify the status of the BLA to the public, including noting that “ he BLA will not be considered
completed until the Company submits to the FDA clinical datasets required to address FDA
comments it received in March 2020.” Indictment ¶ 46."
Pages 9-10:
"In the April 14, 2020 e-mail
that the Government relies on, Dr. Pourhassan wrote, “Please file the BLA no later than next
Wednesday, even if we are short in no matter what portion of whatever it is that we are short.”
Indictment ¶ 37. The Government fails to explain how an out-of-context e-mail to Amarex that
“the BLA should be filed even if it was ‘short,’” equates to Dr. Pourhassan instructing Amarex to
file an “incomplete” BLA. (...)
In fact, the BLA was filed on April 27, 2020 (Indictment ¶ 38)—two weeks after the April
14, 2020 e-mail from Dr. Pourhassan—certainly not the following “Wednesday” as Dr. Pourhassan wrote
Second, the Government alleges that Dr. Pourhassan “falsely claimed . . . that CytoDyn
had submitted a ‘completed’ BLA when he know [sic] that it had not” (Opposition at 29;
Indictment ¶¶ 16, 39-40) but omits the important fact that CytoDyn’s press release and investor
call was held on April 27, 2020. Indeed, according to the Indictment and Opposition, this press
release and investor call both occurred three days before April 30, 2020 when the Indictment
alleges that Dr. Pourhassan received from Amarex the FDA e-mail stating that the BLA was
incomplete. Indictment ¶ 42. (...)
Additionally, CytoDyn’s corrective disclosures in May 2020 following the filing of the
BLA, negate, rather than support, a finding of fraudulent intent. Motion to Dismiss at 9. The
Government alleges that CytoDyn’s press releases in May 2020 “falsely claimed that a complete
BLA had been submitted, knowing that CytoDyn did not possess the necessary data to complete
the BLA.” Opposition at 29; Indictment ¶¶ 45-48. To the contrary, these corrective disclosures
clarify the status of the BLA to the public, including noting that “ he BLA will not be considered
completed until the Company submits to the FDA clinical datasets required to address FDA
comments it received in March 2020.” Indictment ¶ 46."
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