Replies to post #215096 on Biotech Values

[DewDiligence]

Has NVS provided any update on the manufacturing issue they have with brolucizumab [RTH258]?

The BLA is delayed until NVS can complete a bridging study to show that the two formulations are equivalent.

[DewDiligence]

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.