When are the PI's coming????

my doctor says early next year... anyone else????????????  

i think he is being too optomistic but im hoping he is RIGHT

[pjhep80]

from the Vertex website...

Telaprevir Phase 3 registration program in hepatitis C on track; NDA submission anticipated in second half of 2010 -

NDA.... what is that?  is that like the FDA?   and how long to get it thru i wonder...

so tired of waiting....

[HCA]

Can't be early next year 'cos the SVR 24 data on Telaprevir phase 3 won't be collated until June.
Then the new drug application has to be filed and approved.
Most informed people say 2011.

[Willy50]

NDA= New Drug Application

Vertex has mentioned very late 2010 as a possibility but says 2011 is far more likely.
(barring any problems, of course)

Over 2000 have been dosed with TVR.  All TVR dosing has finished in all trials at this point.

best,
Willy

[newleaf09]

My doctor (participating physician in Schering Plough trials) says that it was originally announced that teleprevir would get approval in 2010 but thinks there have been a few snags, so it and boceprevir will more likely be out in 2011.  I'll bet you could trace the release information through press releases made by Vertex (teleprevir's owner) to investment websites.  They put out a lot of releases but Schering (boceprevir) puts out very few.  Boceprevir is well through the current phase 3's (think their dosing will all end in October) and I imagine they will come to market very close together.

[Debbie556]

Vertex will have all the clinicals of the phase 3 trils completed by the first couple of weeks  in Jan 2010. From what I have heard they are trying to Fsat track it for FDA approval so if so many people out there can wait. The drug works and it is only for 24 weeks of treatment.. That is what I know as far as it working for hep-c 3 patients. good luck