Replies to post #63334 on Biotech Values

[ThomasS]

VRTX: I don't know that I'd agree; however, I remain impressed by the drug's utility and probable success. My earlier comments re "double-double" in treatment-naive patients is key. (Double the efficacy in 1/2 the treatment time.)
The FDA's responsibility is to assure us of a safe drug, regardless of the efficacy. HCV can be deadly, but it ain't pancreatic cancer.


"Three may keep a secret, if two of them are dead."
- B. Franklin

"He has all the virtues I dislike and none of the vices I admire."
- Sir Winston Churchill

[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.