@DmitryKovalchuk@BioWino in fairness they had it in the bullets at the top as well. "Pre-NDA meeting held for volixibat in cholestatic pruritus due to PSC; additional discussions planned before potential NDA submission, now targeted in H1 2027"
@avidresearch Its annualizing at $800M. Opzelura net sales of $450 million, an increase of 173% versus the prior year period; excluding the one-time, non-cash benefit,* Opzelura net sales were $204 million, an increase of 24% versus the prior year period
@DavidDPope@pknoepfler Thank you for the reply, David. I watched most of the panel and the video to which you linked. Based on that video, I think those who voted in favor of adding peptides to the list were using a different standard than FDA. Not sure where the FDA standard came from in the law.
@avidresearch@greybio1@PositiveTopline@LetMeFireASAP So FA patients have 10-20% of unaffected people's FXN levels. Getting to 50% is curative. Assume they were 15% at baseline, 125% of baseline means they are now at 19% of normal. I guess phase 3 will tell us if 19% of normal results in a clinical benefit compared to 15% of normal.
@BrainDonor@Kid_From_Bklyn@adamfeuerstein I think the transfer price is too low and the ASP will be the transfer price instead of the final price that they want. As such, doctors will be reimbursed ASP plus 6 and they will be massively underwater and can't administer it.
@adamfeuerstein@ADeAngelis_bio When cosmo reported percent change, it wasn’t percent change from baseline, it was how much more hair growth there was in treatment arm than the placebo arm for that trial.
@John_Hempton@adamfeuerstein@DmitryKovalchuk Seems that REGN owend 8.6% of the company when it came public, they owed $35M per project and were on the hook for half of dev costs. Interestingly no rev projections with the deal background. https://t.co/vOQMIxmTwO https://t.co/akVGcPIlAF