Replies to post #197071 on Cytodyn Inc (CYDY)

[HyGro]

It is ALL other trials, so you didn't even look at the press releases that did not claim statistical significance for meeting a clinical trial endpoint. You can't find one other than HIV Phase 3.

[3X Charm]

Yes. IDIOT NADER Did A 2 dose trial, when 4 doses were needed. SMH.

Yes let’s run this trial when we know it’s not right and hope we get a good result…GOD WILLING, HOPEFULLY, MAYBE, IF . LAUGHING!

Even Lalezari said Nader screwed up the FDA relationship so badly, FDA does not respect his opinions. HIV was a big smoke signal for FDA on CYDY competency, which failed miserably with an RTF based on a purposeful botched submission package.

Think FDA didn’t sniff out the incompetence at Cydy. They even cited info CYDY had been warned about previously in the RTF. BIG CREDIBILITY BUSTER.

Zero trust on trial design.

All at Naders feet.

[that_little_voice]

I will let others provide the list but I will provide Nader comment on the conference call this week regarding their latest HIV EA debacle.

" We have people on right to trey and with expanded access that we filed for HIV multi-drug resistance, obviously, that's a very important filing. WE have a problem with our protocol and there's need to be modified,we didn't do a good job filing the protocol that we did. We are now going to do a better job and FDA told us that and we are going to send the right protocol the right way and they give us GUIDANCE as always.

Lot to unpack here. My take and always my stance is that CYDY does EVERYTHNG FOR THE PR. I would wager just like the BLA, Nader instructed the team to file it ASAP so they can stop the share price decline. Even on the call he kept hammering Recknor, Nita and the CRO every single day to file. This shows his fire first ask questions later stance which is never a good stance for a biotech CEO. This shows how inept this team is that they can't even file the protocol the right way. Nader always says they hire only gold and get rid of waste. Making this type of mistake AGAIN is not winning over any friends as FDA. Between this, RTF letter and statement it shows a pattern of sloppy and shoddy work.

Also, I find it interesting how he didn't say, " Send the right protocol for FDA approval for EA (Which is what the PR claimed). I find his use of the word GUIDANCE to be very interesting/telling. Almost as if he knows there is no chance of approval and only looking for future guidance which the FDA will always give any company.