Replies to post #197481 on Cytodyn Inc (CYDY)

[docj]

At the least, the FDA and CYDY management are having ongoing and professional communication. Puts to rest some posters argument about the relationship being ruined.

[C-20]

It would seem to be positive but we also thought the DSMC letting us continue our trial was positive also , except for the extended time period from all case mortality day 14 to day 28 and then 42 which was as we know now was dilution of our results . I hope it’s a turning point but I’m very cautious of the there intentions toward CyDy and Leronlimab

[StealthGold]

This is a gentle reminder to CYDY to prespecify groups if any and the expected analysis to be done BEFORE results are out to avoid the disaster of CD12 and CD10 where data mining was done.

The FDA is tearing CYDY like a school child.

On the relationship side it is not that it is unsalvagable, more like they need professionals with experience and credibility who can speak to the FDA folks to get the job done the FIRST time and not waste another year “learning”.

[cytodyn storm]

I don't quite understand how you have made the enormous leap from the FDA's plain and simple language referring to "analysis details" relating to "randomized trials":

“As there are now several completed, ongoing, or planned randomized trials of PRO140 (leronlimab) that include severe or critical hospitalized COVID-19 patients, any integrated or meta-analysis would be strengthened if you prespecified analysis details and submitted these for review before results of ongoing or planned trials are Unblinded.“

To somehow being inclusive of "eINDs, right to try, etc.":

"What that, along with the rest of the PR contents, says to me is that CYDY asked the FDA for approval to include an analysis of the results of other past and ongoing LL usages (not just Trials; also eINDs, right to try, etc.) with the CD20 analysis. The FDA appears to have approved (?) but wants to see that “meta” analysis of all those “other” uses before CD20 data are unblinded."

[3X Charm]

All this is saying is FDA wants a definitive plan and defined scope instead of throwing stuff at the wall and data mining post hoc.
As is Nader’s history.

[Blueheel1]

It seems positive - and that "the well isn't poisoned" with the FDA, which to me is great. I always maintained that at some point we needed to repair that dialogue - so maybe this proof of that.

However, what does it mean in terms of timing? We're starting a new trial - so we need to fill the trial, run for 28 days, lock, analyze, etc.

I assume we'd have results sometime in Q1 of next year?