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Posted On: 01/21/2021 11:21:55 PM
Post# of 148951
Re: chazzledazzle #73756
“Hmmm. Probably imply that Cytodyn could fail in HIV. Or take too long. Or other drugs would cross the finish line first. Or a whole new trial would be needed - like 48 weeks.”
1. The HIV combo BLA is delayed until at least the end of the 2nd quarter per NP.
2. There has yet to be a pivotal protocol for a mono phase 3 submitted.
3. The current monotherapy phase 3 is a 48 week trial.
4. Other drugs will cross the finish line first. That’s the nature of the biotech game.
5. No where did I say that HIV will fail. The 47 patient trial and the results from the mono trial show clear efficacy, but the BLA for combo is delayed as is monotherapy.
1. The HIV combo BLA is delayed until at least the end of the 2nd quarter per NP.
2. There has yet to be a pivotal protocol for a mono phase 3 submitted.
3. The current monotherapy phase 3 is a 48 week trial.
4. Other drugs will cross the finish line first. That’s the nature of the biotech game.
5. No where did I say that HIV will fail. The 47 patient trial and the results from the mono trial show clear efficacy, but the BLA for combo is delayed as is monotherapy.
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