During yesterday’s VTRS 3Q21 CC, COO Rajiv Malik said VTRS and RVNC met with the FDA in Sep 2021 and obtained the FDA’s buy-in on the clinical data and analytics needed for an eventual 351(k) submission, which VTRS expects to occur in 2024. Malik further said that RVNC’s Daxi CRL will not affect the timing of the Botox-biosimilar program.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.