Biotech Values

[DewDiligence]

With such small patient population in US, it is possible to get accelerated approval… The question is whether FDA can be persuaded on the panel's suggestion that surrogate endpoint is reasonable predictor of clinical benefit. For ultra orphan indication, the chance is there…

I suppose it’s possible, but I didn’t see anything in the FDA briefing docs (#msg-75849163) hinting at such an outcome.