That's another very good question for the next investor briefing.
Based on previous studies, I was expecting the number of patients with >80% repigmentation at week 52 to have increased in comparison to week 24 so I was assuming they'd announce those results too.
However, when reviewing the vitiligo clinical trial, I noticed that there isn't an outcome measure showing "Proportion of Responders for RECELL-treated areas versus Control at Week 52" like there was at week 24, see below. Could that be the reason? Maybe they'll be released in a publication instead?
Still, FDA approval has been granted, and in comparison to the only other FDA approved vitiligo treatment, results are superior at week 24 (at least), safer, one-time and durable treatment, and they seem to be doing ok:
Results at Week 24, which were consistent across both studies, showed that approximately 30% of patients treated with Opzelura achieved ≥75%improvement from baseline in the facial Vitiligo Area Scoring Index (F-VASI75), the primary endpoint - https://investor.incyte.com/node/22171/pdf
https://investor.incyte.com/static-files/2b6be64b-79af-4971-884c-886c3e1e9b5d
I'm assuming the post-market study for reimbursement and clinician based studies that they'll now start working on, could provide the additional information (including 12 month results) required for commercial success.
Hopefully JC can provide some additional commentary in August.
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That's another very good question for the next investor...
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