RVNC
A 3-4 month delay in and of itself is not such a big deal, but the question of whether or not it signifies some deeper issues going on at the company is a big deal. I'm not sure I buy the 100u vial story as the driving reason for the delay, but here are some preliminary thoughts w the caveat that I haven't listened to the cc yet:
1. I actually didn't know management was going with a 50u vial I just assumed 100 or 200u vials since that is how botox is offered and if anything daxi requires double the dose (for glabellar lines at least). So you have to wonder why they weren't working on a larger vial from the get go. Having said that, a smaller vial for a new entrant makes sense bc until you ramp up sales practices will incur a lot of waste if one vial serves multiple patients since once the vial is reconstituted the shelf life is limited
2. Even though 50u is enough for glabellar lines, I wonder if KOLs felt it wouldn't quite do the trick for a good number of patients if they are also getting additional units for things like crows feet.
3. I went back and checked how long it took evolus to file. They had a pre-BLA meeting October 2016 and submitted their initial BLA July of 2017 so 9 months. Revance had their pre-BLA meeting Dec 2018 so 1H 2019 in retrospect was a bit aggressive probably for this kind of a filing.
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