That's what I have worried about. Revance Therapeutics, Inc. RVNC announced that the FDA has deferred its decision on the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection for the time being.
The candidate is an investigational neuromodulator product and the BLA is seeking approval of the same for the treatment of moderate-to-severe glabellar (frown) lines.
The agency informed on Nov 24, 2020, that an inspection of the company’s manufacturing facility is required as part of the BLA approval process. However, it was unable to conduct a required inspection of the company’s Northern California manufacturing facility due to the travel restrictions associated with the COVID-19 pandemic. Hence, the delay in the decision.
I think that FDA needs to inspect BCRX's facility too. Hope that I'm wrong.
News 
Market Data 
Discover 
