Replies to post #148799 on Cytodyn Inc (CYDY)

[PNW_Ironman]

This is what “moving the goal posts” looks like.

[daemon57]

MFGinvestor - This actually answered my previous questions regarding material events.
Thank you very much for sharing this.

GLTU/A.

[Blue Man]

So, would they be discussing the possibility of obtaining more data on the patients in the trial to day 60 with mortality? Might take a bit but would only need to see who is alive or died? Not sure what other stats the FDA may want other than mortality. And I still have not seen anything that Cytodyn followed the recommendation by he DSMB to measure 42 day mortality. It makes sense why DSMB made the recommendation.

[ClosetInvestor]

Let’s do some math:

FDA recommendation for non-critically ill patients - 28 day mortality

FDA recommendation for critically ill patients - 60 day mortality

The average recommended mortality endpoint between the two groups - 44 days

The DSMC’s recommendation at the 50% analysis: conduct a review at 75% and review 42 day mortality.

42 days (DSMC) is awfully close to 44 days (FDA average). The DSMC was onto something before the FDA was and that’s because they saw all of the data at 50%. The data is even clearer at full enrollment.

[Mohave]

A long shot idea of mine, but could the FDA be using Leronlimab as the Gold Standard for future severe/critical Covid19 therapeutic drug trials, since Cytodyn used all-mortality as their primary endpoint? Also, would Cytodyn's trial be Grandfathered in and be exempt from these new guidelines. If not, wouldn't day 60 be on March 13th? I'm basing this off of full enrollment reached on Dec 15th, Jan 12th being day 28, then reaching day 60 on March 13th. Monday, March 15th could be announcement day which would be 3 weeks from the day of NP's Feb 22nd announcement.

[SizzlChest]

I have a friend of mine that is invested almost as heavily as I am in CYDY.

He tends to be the optimist and would say that the FDA will work with CYDY to make sure that the trial we concluded is treated fairly.

I tend to be the pessimist and say, damn that F'da. They just find more and more ways of denying this life saving drug from reaching the American people while allowing more time for their BP buddies to try to come up with something to get to market first.


If the FDA screws us over with this then it's time for the gloves to come off. No more mr. nice guy Nader. Get on the phone with N. Korea, Russia, China, Iran, Syria, Cuba, Brazil, Argentina, Philippines, Iceland ....

And let them know this drug is for sale. Screw the FDA for causing harm to the American public while authorizing inferior drugs.

The timing of this rule change by the F'da is awfully suspicious.

I hope my optimist buddy is right. I would love to be wrong and will be the first to admit it

[Maverick0408]

This is actually a positive development for CYDY in my mind. FDA wants to approve this drug with meaningful data and outcome. If the data was bad and they weren’t interested in CYDY drug, they wouldn’t have been talking with us anymore...We are past the 60 days from the last enrolled patient, so we wouldn’t lose much time in extracting this data from the sites. In fact, they may already be looking and analyzing this data (at 60 days), as we speak. My prediction is we should have EUA around mid to end of March!