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CytoDyn Inc CYDY
(Total Views: 600)
Posted On: 03/26/2022 12:27:19 PM
Post# of 154881
Posted By: gestalt2
Re: bucweey34 #120714
What really upsets me about BTD s it’s purpose and when it is awarded. It is a shortcut given to biotechs because the drug potentially serves a terrible disease that has not many other treatments. The whole point into give BTD early, the later it is given the les helpful it is. Cytodyn has only been able to get through p3 trials because the fda give them small trial sizes. The problem with this is that it is hard to get statistical significance with small trials. The fda needs to give BTD so Cytodyn can attract partners that can get big enough trials enrolled quickly so les time is wasted. To give a BTD in phase 3 is stupid, the hard part is mostly done already. Cytodyn has been very public that Nash and cancer will only go to phase 3 with a partner. I wonder if it would be better to not apply for BTD until we have a partner, the risk that the fda does not give it can hurt more than it helps.let the partner pave the BTD process? Maybe?













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