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Re: BakedLangostino post# 508246

Friday, 11/14/2025 7:22:16 PM

Friday, November 14, 2025 7:22:16 PM

Post# of 517480
Once we get the CHMP feedback we will know what they felt were the data shortcomings.
It may be such that submitting a new MAA with the fresh data now in hand would suffice.

A new Phase 3 will add three years of delay before a decision.

Maybe a better course would be to now submit a NDA with the FDA with the total data package we already have. Why not?
TGD mentioned that discussion in today’s PR.
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