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Hoskuld

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Hoskuld

Re: Guzzi62 post# 415302

Sunday, 05/14/2023 8:43:04 AM

Sunday, May 14, 2023 8:43:04 AM

Post# of 458279
The trial was large enough to show statistical significance on all primary and secondary endpoints. The "N" does not need to be any larger to show efficacy. In addition, the company has data from several trials - and several years of data from this trial and the OL continuation of it - to prove 2-73 is safe.

There is no plausible reason not to proceed with application and approval. I don't think Dr. Missling would have publicly discussed commercialization and P4 post-marketing trial had the FDA not confirmed this path is the one they should pursue.
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