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Re: oc631 post# 164641

Monday, 07/29/2013 11:17:06 PM

Monday, July 29, 2013 11:17:06 PM

Post# of 257262
VRTX

I'm not sure what was discussed on the call today. A hold has been placed on the VX-135 200mg dose by the FDA. The 200mg dose may relate to European studies.

The 200mg dose of VX-135 in combo w/ribavirin in EU studies was apparently safe; it was just the 400mg dose that had a few issues. Despite that issue was just with 400mg dose, FDA placed 200mg dose on hold and let 100mg dose continue. Sounds like VRTX thinks they have enough data to ultimately get that 200mg dose off of hold (assume part of that is the actual data in EU patients at 200mg dose plus other pre-clinical data).

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