Biotech Values

[DewDiligence]

RVNC—Someone who has better knowledge in this area might chime in, but I didn't see anything resembling a three month fix in the FDA form.

Which specific items are you referring to? Item #2 — that a (slightly) different manufacturing process was used in the Daxi clinical trials compared to the process for commercial product — is a pretty common FDA concern that is usually handled by a short “bridging study” to demonstrate that the two processes produce equivalent output. Such a bridging study could already have been completed.