Biotech Values

[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?