Biotech Values

[DewDiligence]

>VRTX – 52% SVR in non-responders. I think this answers Dew question regarding the early filing scenario. This is it. The FDA would be irresponsible not to allow this to go through in the most expeditious manner.<

We still have to see the SVR data!

In patients who have failed prior therapy, there’s a higher probability of relapse during the period from 12 to 24 weeks after the end of treatment than there is in treatment-naïve patients, and hence the SVR12 data (what we’ve seen so far) are not as indicative of SVR.

Obviously, the interim PROVE-3 data look very good, but there’s zero chance of an NDA submission based on less than the complete data from this phase-2 trial.