For sure the extra study was prescribed, BIT have skipped any announcement that they are talking positively to the FDA until they get the go ahead for trials. Hopefully it also means they've been able to stump whatever cash fees are required to engage at this point from exiting reserves.
Once the go ahead is given, expect review of clinical protocols within 24 hours, review of single patient expanded access requests within 3 hours.
A presentation in 2021 from FDA reviewer and Division Director of Pharmacology/Toxicologyfor Infectious Diseases shows their Covid timelines, the third animal trial could be a response from day 14-17:
Ann: BIT225 EFFECTIVE AGAINST ESTABLISHED SARS-CoV-2 IN ANIMALS, page-157
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