Agree with this. It all seemed premature given th
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Posted On: 02/25/2020 4:38:34 PM
Re: ClosetInvestor #19342
Agree with this. It all seemed premature given the very limited- though very exciting- data. I say that without knowing much about how the FDA approaches BTD filings. Knowing the extensive trial data required for just about anything makes it incomprehensible to me that they give us the BTD based on basically 5 patients. I get it that we are trying to treat a deadly disease and we have a mountain of safety data from HIV trials, but it still doesn't feel like a realistic outcome. Hope I'm wrong and we can start saving lives.
If they don't approve BTD, do we have to open up a full P2/3 trial then? Can we gather more data from the basket trial and reapply?
If they don't approve BTD, do we have to open up a full P2/3 trial then? Can we gather more data from the basket trial and reapply?
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