Really? I'm not sure Nader is thinking of a repeat
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Posted On: 10/16/2019 10:38:17 AM
Really? I'm not sure Nader is thinking of a repeat process of getting the cancer trials all the way through approval without a partner involved early. It could be, as long as the unmet need nature leads to approval from just p2 data, but I don't see Cytodyn raising funds to pay for a p3 trial on its own.
I feel the attitude is to prove the concept as a cancer drug ASAP to all possible partners and negotiate from there. The big difference this time is we will have the HIV combo BLA filed/approved so the heavy lifting is done. At this point the efficacy in each indication is all that matters, the difficulty of FDA p3 trials, safety and dosing is behind us.
I feel the attitude is to prove the concept as a cancer drug ASAP to all possible partners and negotiate from there. The big difference this time is we will have the HIV combo BLA filed/approved so the heavy lifting is done. At this point the efficacy in each indication is all that matters, the difficulty of FDA p3 trials, safety and dosing is behind us.
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