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abew4me

07/11/23 5:37 PM

#422422 RE: Steady_T #422402

Quote: One can make a reasonably strong argument that having 2-73 approved for Rett improves the chances of approval for AD.

Yes. The FDA has two specific pathways for NDA approval.

1) You must submit two successful Phase 3 trials - but there are a few exceptions; or

2) One successful Phase 3 trial and the submission of that same drug (A2-73) for an already approved disease...which, in this case, would be Rett.

And frankly, I believe that was the original plan that Dr. Missling intended. So, it wouldn't surprise me if Dr. Missling follows through with that strategy. Especially if it increases his chances for approval and expedites his submission timeline.


This is where Dr. Jin's expertise and experience is most needed.