Replies to post #215586 on Biotech Values

[DewDiligence]

(RVNC)—I mentioned Daewoong’s botulinum toxin on this board in 2016 (#msg-121755626). I was initially skeptical that Daewoong’s US partner, Alphaeon/Evolus, would submit a BLA, but they recently did so now we’ll get to see what the FDA thinks about Daewoong’s manufacturing facilities in Korea.

Botulinum toxin in bulk form is dangerous stuff! I have an inkling the FDA will regard RVNC’s all-US supply chain as comforting, unless a major earthquake hits Silicon Valley, LOL.

[Bickema]

Cosmetic market only, not therapeutic

“Nabota is only going for the cosmetics side of the market and that size is growing very quickly,” Alphonse said.

[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.