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flipper44

12/09/25 8:58 PM

#802074 RE: Investor082 #802072

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.