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Steady_T

01/18/21 5:04 PM

#293280 RE: DFRAI #293274

Trials were not what was being discussed. The subject was New Drug Applications (NDA).

I agree with your point. The previous P1 & P2 trials will advance things to P3 quicker. The exception being the pediatric trial for Rett. That is the first pediatric trial so the FDA is properly very cautious about2-73 and children. Whether the Rett pediatric trial will influence the Fragile X pediatric trial I do not know.
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ExtremelyBullishZig

01/18/21 7:44 PM

#293291 RE: DFRAI #293274

Not exactly.

Phase 1 is for safety regardless of the indication. Phase 2 is specific to the indication.
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nidan7500

01/18/21 7:53 PM

#293293 RE: DFRAI #293274

DFRAI

If they have phase 1 and 2 for a273, they should be able advance other orphan diseases much faster to phase 3



Agree that seems plausible.