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iryokabu

11/25/21 9:37 PM

#361358 RE: Laurent Maldague #361353

Most likely Amarin does not need additional CVOT for once a day formulation. Only need bioavailability (BA) and bioequivalence (BE) test.

https://www.fda.gov/files/drugs/published/Bioavailability-and-Bioequivalence-Studies-Submitted-in-NDAs-or-INDs-—-General-Considerations.pdf

Whalatane

11/26/21 1:09 AM

#361366 RE: Laurent Maldague #361353

Laurent. Interesting and probably under consideration
In the mean time re MITIGATE… Covid is raging in their (Kaiser ) key recruiting county .. San Joaquin county in Ca
ICU’s overrun with unvaccinated Covid patients
In late Feb thru March Mitigate will read out and tell us if being on V reduces risk of Covid hospitalization or not

Right now we have the PFE pill awaiting approval . That’s taken once infection is confirmed
Be nice to have a low cost option that reduces MI’s and strokes … as well as reducing Covid hospitalization rates it you’re infected

Hope U had a good turkey day
Kiwi