Replies to post #27611 on Biotech Values

[ThomasS]

VRTX: Also, folks need to understand that testing viral load during treatment is inconclusive (one would expect VR during treatment, yet perhaps not SVR); hence the reason of testing 6 months after conclusion of treatment (gold standard of "cure") plus usually again after 18 months post-treatment.
If there is not a definite VR of magnitude after, say, 4 weeks of treatment, most GI Specialists will opt to discontinue, sparing the patient the debilitating side-effects for a probable treatment failure.

[mskatiescarletohara]

Hey Dew, Thomas et al....VRTX

Thanks for the commentary on the Phase II update from VRTX, I will have to listen in later this week.

+++The rationale, as it was explained on today’s CC, is to see if the additional time on peg-interferon+ribavirin will allow the immune system to clean out any remnants of HCV that might remain after reducing the viral load to the limits of detection during the 12 weeks of VX-950.

This sounds like the FDA will only allow VRTX to test for 12 weeks only and are not willing to take a chance for it to be tested longewithout further the six month animal tox studies.

+++VRTX thinks this treatment epilogue is unnecessary, but they want to test such a regimen in phase-2 to preempt a demand that it be tested later in the development program.

Sounds like spin to me,perhaps this is the only protocol they can get approved right now, the FDA is a not allowing VRTX to proceed to six month dosing without animal tox data, and it's questionable whether the 12 week dosing will yield SVR.

Hmmmmmm.

I'll post this on the PPHM board and see what others have to say...


Thanks again Dew.

katie....