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SC8

Re: None

Thursday, 09/01/2022 8:54:44 AM

Thursday, September 01, 2022 8:54:44 AM

Post# of 175025
Appreciate the candor in update but very sad. Contrary to May update, path forward is neither clear nor simple. Can only hope at third meeting (whenever that occurs), perhaps they work out with FDA an alternative easier animal containment verification model that can satisfy FDA concerns. Odds of IDE approval on this path look no better than 50/50 and could take years. Appears big sellers knew something.
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