Replies to post #21693 on Cytodyn Inc (CYDY)

[misiu143]

Yes , you are right with some things , FDA agreed with most of the things CYDY asked for,
and for FDA to do that is a big deal .

So , personally , even that I am also tired from waiting , I do have a lot of respect for management , they did unbelievable work with Pro 140.!!!!!

[trding]

My understanding was that CYDY chose to seek the narrower and more restrictive protocol bc they thought they would get ODD... another boneheaded move that management should have known the qualifications before veering the whole ship on off course just like they did with the RS and uplist.

I believe they requested to lower it from “least one ART drug within three drug classes” to two drug classes but the fda denied the request. We would not be in this situation imo if they had approved the two. Then after it took forever to find the patients meeting that strict criteria, the fda declined ODD... which is very odd to me. So the fda shares a lot of blame IMO. I believe having known what the know now, the fda would have granted the two— as they allowed that modification to get the additional 10.

Also, the FDA allowed some other combo ART trials with less than 50. So, again the FDA has some blame there as well. My impression is they thought 40 would be it and had the 40 going into the meeting, the additional 10 above what they expected took another 4 months to fill.