NVS/(REGN)—Addendum to #msg-136172038: Unlike the FDA, the EMA has not requested that NVS conduct an RTH258 bridging study and is willing to review an MAA for the product from the revised (higher-yielding) manufacturing process even though the phase-3 trials were run with the old (lower-yielding) process.
Nevertheless, NVS plans to wait until late 2018 to submit both the FDA BLA and the MAA so that the MAA can include data for both the vial and prefilled-syringe presentations.
Source: NVS’ R&D Day webcast on 11/13/17.
“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.