While the FDA does not typically grant "conditiona

While the FDA does not typically grant "conditional approval" based solely on Phase 2 trial data, it is possible to receive accelerated approval under certain circumstances, which could be considered similar to conditional approval, if the drug shows promising results in Phase 2 trials for a serious condition with unmet medical need, allowing for further studies to confirm full efficacy in Phase 3.

Key points to remember:
Accelerated Approval Pathway:
The FDA's accelerated approval pathway allows for earlier approval based on data from Phase 2 trials if the drug demonstrates a significant effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, but further confirmatory trials are still required.

Unmet Medical Need:
To be eligible for accelerated approval, the drug must target a serious condition with limited treatment options.

Confirmatory Trials:
Following accelerated approval, the drug company must conduct additional Phase 3 trials to verify the clinical benefit observed in Phase 2.
___

Have not looked @ the actual FDA rule book for trial size requirements per say; but this is what the cheat sheet, I mean Ai says.

Giving Phase 2, & continuation, it kind reads our 60 patients possibly could qualify requesting from FDA on great, not good, great results.

Have never used Ai until recently.
Feels crazy seeing things just pop up like that.

Lol.
Anywho.....