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RVNC
OCUL
Me: Note: their apparent justification for a protocol allowing 15 point loss is that they will start with 20/20 patients and 15 points corresponds dropping to 20/40?
Response:
OCUL thoughts:
1) Context: Vabysmo phase 3 trials, which were really more about protocol change than better drug per se, showed that innovative trial designs leads to immense market gain. Vabysmo trial design, as described, for example, in FDA Statistician Review, is all above deciding which patients can be allowed to go longer time between injection, and which cannot:
OCUL
Revance website of injectors:
Have you done an audit? Eg for a given region of US (eg small city) tried finding all sites listed by Revance? Then matching it against what a Google search turns up for injectors in that area. I did that 4 or 5 months ago for two different regions and it was an absolutely appallingly bad match. Lots of false negatives and positives (providers on Revance site that didn’t list it on their own website, lots of providers that had it on their website, but not in Revance database). And note this wasn’t just because Daxxy was dynamic since similar sized problems showed up for RHA, which is more mature and thus less dynamic.
It would be great to have a working database - both because it implies institutional competence and provides insight.
Anyone found a social media site that has recent experiences by injectors? (The one below is very stale at this point, but I couldn't find a more recent one. Which is a little surprising and may explain some of the slowness wrt injection/pricing knowledge diffusing out??)
KYMR CRIS IRAK4
VERA
Atacicept is a blast from the very long ago (in biotech terms) past. ZGEN was a long time ago. I even remember their headquarters in Seattle, back when Seattle was a biotech center.
Atacicept seems to work well in the renal disease space, but it’s blown up in the past on safety for some indications. So that seems the big risk?
FWIW - this response has some reasonable points even if I don't completely agree, so a response below:
CARA just discontinued their almost completed ph3s in non-dialysis CKD. To provide runway to the indication that had the strongest ph2 results (Notalgia Parathetica (sp?)). Note further they were very clear they did not terminate the CKD trials because they had indication they would fail - but clearly they have immense money problems and can’t pursue both CKD and NP.