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Re: RedShoulder post# 369999

Wednesday, 08/10/2022 5:02:25 PM

Wednesday, August 10, 2022 5:02:25 PM

Post# of 458282
Curious. Would FDA consider other WW trials (RSD, PD/PDD, AD...other lab WW findings/data) while evaluating an NDA, other approval for A2-273. A compilation of safety evidence from multiple trials conducted by/w other regulatory body evidence of compliance and safety as a type of variation of basket trial . Does such strong evidence support BTD finding, also considering the potential impact WW of such a finding? It's about the MOA.

The FDA could rewrite its recent history and make a lot of very sick (families) happy. FDA would then be on the longest Christmas card list in the world . Just a thought, why not?
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