Biotech Values

[DewDiligence]

Re: Near-term bearish event for RVNC?

The only near-term bearish event for RVNC I can think of is the FDA’s refusing to allow the 351(k) approval pathway for RVNC’s Botox-biosimilar program partnered with MYL (#msg-138921254). If the 351(k) pathway can’t be used, this program would be DoA since it doesn’t make economic sense for MYL and RVNC to fund a full array of clinical trials in manifold indications for a product that’s merely a Botox knockoff.

However, the above scenario is not that bad an outcome. RVNC would have no further R&D obligations related to the program, but they would get to keep the $25M received from MYL.