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CytoDyn Inc CYDY
(Total Views: 887)
Posted On: 04/18/2023 7:11:07 PM
Post# of 154883
Posted By: Hulk767
Re: gestalt2 #134171
i look at this very simply. the FDA screwed us. probably has something to do with Nader - i'm sure that still hangs over our head, and they are gun shy about all things CytoDyn-related. but the theory that somehow the BLA is now magically just around the corner is to me, highly unlikely. Cyrus was very clear that we would not pursue the HIV BLA - not only because of the time & money to complete, but also because HIV is not nearly as big a market as cancer / NASH. his NPV analysis (which is the right thing to create) leads him to pursue the lowest hanging fruit / biggest near-term markets. those are cancer and NASH - and everything else is a distraction. i believe that's still where we are.

what's more interesting to me, and actually in the realm of possibility - is this. i fully believe we were entertaining discussions with a potential partner on cancer, during the past several months. They want to see the hold lifted - as a potential safety issue spooks potential partners - i get it. but.....we addressed all of the safety concerns. this "new request" has nothing to do with safety. so - is there a chance that our potential partners says "we were worried about safety - you've proven that's not an issue - we don't care about all of this other BS the FDA has drummed up - let's partner on a solid tumor trial".

that would be really interesting - and i believe possible. i would love to see it - as i think we're still months away from clearing this new BS roadblock the FDA has thrown up.













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