Comment BMD if I am wrong but it seems that the FDA has already granted Biotron permission to FAST TRACK as our COVID trials skipping from Pre-clinical straight to Phase II.
Thé significance of this huge jump can not be overestimated and speaks volumes of their confidence in BIT225 as a potential drug for COVID-19.
Ann: POSITIVE FDA GUIDANCE FOR COVID-19 CLINICAL PROGRAM, page-166
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