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Re: Investor082 post# 802072

Tuesday, 12/09/2025 8:58:44 PM

Tuesday, December 09, 2025 8:58:44 PM

Post# of 818540
Investors like me did not know until recently that #1 (below) was messed up up by manufacturer Fikst, and apparently finally cured by another manufacturer, imo, effectively, around November 20, 2025, imo, because that’s when C suite construction started.

1. The GMP compliant design and post approval comparability plan were needed for the MAA.



2. The actual comparability testing is accomplished post approval.

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