Replies to post #27857 on Biotech Values

[DewDiligence]

> VRTX chimes in with very impressive results from a small study<

The VX-950 results are very impressive indeed, but this has been known since January (#msg-9177786). I don’t see anything in today’s PR, specifically, that changes the competitive landscape.

A cocktail involving HCV drugs with disparate MoAs is likely to emerge as the standard of care in a few years—preferably a cocktail that is all oral (no interferon). Based on the data to date, VX-950 and NM283 seem like fairly good bets to be included in such a cocktail. VX-950 has the drawback of being administered thrice daily but, if the stellar efficacy holds up and there is no major problem with resistance, it ought to be able to overcome the dosing liability.

[poorgradstudent]

viral trials

One question about companies in this space: why are the majority of these trials in such few patient numbers?

I understand that these people's livers are at risk, but given the number of people with HCV, I would think that more than 8 patients could be dosed. If safety is a big concern at the FDA, moving cautiously makes sense to me; but on the other hand, having such small numbers in trials makes it more difficult to spot AEs, especially SAEs that may effect 5-10% of patients.

Is it the FDA acting as the bottleneck, or are companies skimping on the patient numbers that they bring into these trials?