Biotech Values

[DewDiligence]

Medytox alleges fraud by Evolus/Daewoong in botulinum-toxin BLA:

https://www.businesswire.com/news/home/20171205005822/en

A BLA must contain true and not misleading data to demonstrate that a biological product meets FDA’s safety, purity, and potency requirements. Medytox’s Citizen Petition raises serious questions about the integrity of the safety and effectiveness data and information Evolus submitted to FDA. The petition asks FDA to invoke its fraud policy, known as the Application Integrity Policy (AIP), and to require submission of the strain’s whole genome sequence to prove its actual source and identity.

Setting aide the alleged fraud for the sake of discussion, I do question whether Evolus/Daewoong’s Korean manufacturing facilities will pass muster with the FDA (#msg-136587899).

All told, potential competition from Evolus/Daewoong is not especially high on my list of concerns as a RVNC long.