I don't think the FDA will consider the one extendered mouse trial, (12 day mouse trial No 2) to be enough evidence. I think they will require verification form an independent trial (not associated with Biotron). Frankly the results obtained from the second trial seem almost too good to be true. All the mice dying on day 8 seems more Hollywood than real life.
FDA application made for fast track for COVID-19, page-170
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