Replies to post #193215 on Cytodyn Inc (CYDY)

[3X Charm]

FDA public rebuke of failed trial data pumping and lack of ability to create trial protocols and scathing RTF = lack of respect by FDA. FDA Actions speak louder than words. Those are da facts. These actions by the FDA are a black mark and an embarrassment to CYDY leadership.

[Buddyboy20]

Maybe Amarex has earn the FDA's disrespect. From another board:


Aaron

"From Sidley court documents sent in yesterday, page 13, point 39:

"Amarex...has backdated certain letters regarding... monitoring (In violation of FDA regulations)"

That is a direct and heavy accusation. I think we have all learned from Sidley's past documents when they make such an accusation it isn't lightly and they have the evidence to prove it.

If the CRO backdated letters in violation of FDA regulations that is going to be part of a serious tort case."

[Buddyboy20]

More bits of information from another board:

Aaron

"It was last week I believe that the FDA granted us a rolling review for the resubmission of the HIV BLA

Also, from Sidley's court documents, the FDA gave a letter to Cytodyn showing Amarex failed to file annual IND annual reports.

While it is definite that these issues with Amarex put the BLA in danger, it is apparent that the FDA is aware of the situation and is working with Cytodyn to get this completed.

From the very detailed answers in the RTF, I do not believe the FDA would keep moving forward if there was no apparent pathway."