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233616 tn?1312787196

PI time line...teleprevir and boceprevir

Not a question, just an update. I know the chatter has been that the PI's will get FDA approval some time this spring.

However my clinic, who has refused to set a date for years now, finally said they are expecting to see it next year,
but added they don't think it will show up until sometime in summer of 2011. Assuming an approval on schedule, it will still be a while to ramp up and see it in the clinics.

That's what I was told...for what it's worth.

mb
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408795 tn?1324935675
Yup, for a reading of the meeting with Merck Schering and their boceprevir drug check out the link.  I haven't heard of anything on behalf of Vertex and telaprevir but I'm sure they're not wasting any time either as many ppl expect telaprevir to be approved first.  In August Merck Schering said that they will be filing an NDA in 2011.  Vertex has their Ambassador program intact and waiting in the wings to promote tx and whatever else comes down the pipeline.  Usually when bigpharma starts a campaign like the Ambassador Program, you better believe it's just the beginning of something big.  Well the race is on and were not talking about hamburgers here. lol Go team gooooo!!  Which one do you think will get the booby prize of being first?

http://www.fda.gov/downloads/Drugs/NewsEvents/UCM213444.pdf
Helpful - 0
895634 tn?1283989210
That is terrific news.  Though I think the communty as a whole needs to "man-up"/rise to the challenge and get multidrug cocktails out there and follow the lessons learned from the HIV experience.

Robo
Helpful - 0
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