Replies to post #172060 on Biotech Values

[Robert C Jonson]

Thanks! Do you know if the FDA has a list of official requirements that I might peruse?
Bob

[acgood]

That particular FDA page you linked isn't guidance or a list of official requirements; it's just a general overview of how drugs are developed. In that sense, it's pretty clear that the FDA page is saying that, in general, drugs are only brought to Ph3 after showing signs of efficacy in Ph2 [because sponsors don't want to risk a Ph3 if there are no signs of efficacy]. It's not saying that signs of efficacy are mandated by the FDA before Ph3.

Yeah the original link appears to be a tutorial of drug development, much like appears in most biotech company annual report. Implicit in the description is the assumption that companies won't advance a drug to phase 3 without evidence of efficacy. Of course any reader of this board knows this is not always the case.

One nuance to the discussion is that absence of efficacy CAN be considered a safety issue by the FDA. One such example would be requiring a trial design that allows nonresponders to "escape" to treatment with an agent with proven efficacy