Sat, Aug 23, 2014, 12:28 PM EDT - U.S. Markets closed

Recent

% | $
Quotes you view appear here for quick access.

Vertex Pharmaceuticals Incorporated Message Board

you are viewing a single comment's thread.

view the rest of the posts
  • verityvoila verityvoila Nov 13, 2012 1:41 PM Flag

    Vertex hepatitis C situation is unchanged but its cystic fibrosis drugs will be blockbusters

    While I'd love to see the combo to market by 2014, I think it will be 2015 for these reasons: I think FDA will insist on a 1 year trial (we'll know soon, and if only 6 months required, that will make it quicker). Even if they start in early 2013, it could easily be mid-year before fully enrolled and that is with a fast enrollment which I think is a certainty given EVERYONE wants this combo NOW. Which would mean that it would be, at earliest, mid-2014 before everyone has finished 1 year and then you need some time to evaluate and put together application and then if approved on fast track at least 3 more months. We're in the "if we can only keep DS healthy for another 2 years," coping strategy, which I guess would be end of 2014, but now that I think about it, it is more likely 2.5 years. What might change this: 1) 6 month trial; or 2) steller results after 6 months and FDA allows approval to go forward while still in Phase 3 (1 year period). But it could be early 2015. I know Vertex wants/ needs this to market soon, so it will be doing everything possible to get it there.

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • Vertex aims to file the NDA to the FDA by the end of Q4-2014 or Q1-2015. With this timelines in mind, add 4-6 months for approval and VX-809 will not be in the market until mid 2015 the soonest, sometime between June-September 2015. Expect that revenues will not be significant until 2016 with few months needed to launch and ramp up sales.

 
VRTX
90.22+1.23(+1.38%)Aug 22 4:00 PMEDT

Trending Tickers

i
Trending Tickers features significant U.S. stocks showing the most dramatic increase in user interest in Yahoo Finance in the previous hour over historic norms. The list is limited to those equities which trade at least 100,000 shares on an average day and have a market cap of more than $300 million.