Biotech Values

[DewDiligence]

Re: RVNC /100U vial

Is there a valid reason they didn’t have this taken care of ahead of time?

There are two possibilities:

a) Somebody at RVNC made a bad decision in the original plan to go to market with only a 50U vial, and RVNC subsequently got feedback from injectors that a 100U vial was a competitive necessity; or

b) The BLA delay has little or nothing to with a 100U vial, and RVNC is using the dual-vial BLA as an excuse for missing the “1H19” submission guidance.

The funny thing is that I don’t think it makes a lot of difference whether the answer is a) or b); the salient point, IMO, is that RVNC does not have a fundamental flaw in its manufacturing, based on the reasoning in #msg-148712801.