Biotech Values

[DewDiligence]

Additional color on RVNC/MYL Botox biosimilar:

On MYL’s RBC webcast on 5/19/20, Rajiv Malik (President) said that, when MYL and RVNC met with the FDA in early 2019 to discuss the 351(k) pathway for a Botox biosimilar, the FDA raised eight concerns about what was required to show sameness of the proposed biosimilar to branded Botox. According to Malik, RVNC quickly resolved five of these eight concerns, but MYL wanted more clarity from RVNC on the other three.

RVNC submitted a written analysis and resolution of the three concerns to MYL on 4/29/20, which started a contractual 30-day clock for MYL to decide whether to opt in. Thus, 5/29/20 (last Friday) was the deadline for MYL’s decision and we may presume that MYL replied to RVNC then, triggering RVNC’s PR issued Monday before the market open.