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Posted On: 05/09/2022 3:46:13 PM
Post# of 148903
Releasing data is a complex issue; I've read several articles on the FDA and trial data. The first thing you notice is the majority of medical clinical trials are run by Universities and Universities like Harvard are notoriously bad at releasing data because it's about prestige over other researchers, so you don't want them to know if you fail or have success. When you have success then the data is only released to have the most impact on your peers.
So this model is the one I think CytoDyn is following, i.e., there is good NASH 700 data, if Cytodyn releases it to the FDA, they will get "yawn, do another long trial." Since the FDA is not penalizing companies for not releasing data even when they hold it beyond legal limits, CytoDyn is going to maximize the NASH data release by having it front of NASH experts and in medical journals. This will attract a partner.
So this model is the one I think CytoDyn is following, i.e., there is good NASH 700 data, if Cytodyn releases it to the FDA, they will get "yawn, do another long trial." Since the FDA is not penalizing companies for not releasing data even when they hold it beyond legal limits, CytoDyn is going to maximize the NASH data release by having it front of NASH experts and in medical journals. This will attract a partner.
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