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Vertex Pharmaceuticals Incorporated Message Board

papaalien2000 10 posts  |  Last Activity: Apr 4, 2016 12:13 PM Member since: Jun 16, 2003
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  • Reply to

    VX 210 enters late phase clinical trial

    by rojospan Feb 1, 2016 9:05 PM
    papaalien2000 papaalien2000 Feb 2, 2016 7:45 AM Flag

    study is not yet open for participant recruitment, estimated completion June 2018

  • papaalien2000 by papaalien2000 Feb 5, 2016 9:55 AM Flag

    this crl casts doubt on the intended Orcambi sdna. Might be postponed.

  • papaalien2000 by papaalien2000 Feb 6, 2016 6:18 AM Flag

    there is not enough information on the reasons for the cal to understand the reasoning of FDA. there are 23 CFTR mutations and a total of 1.500 patients, so just about 65 patients per mutation. Does FDA expect VRTX to conduct phase III trials based on such low patient numbers? 65 patients per trial with 30 on placebo and 35 on kalydeco?
    safety of kalydeco is proven, preclinical data indicate effectiveness, affected kids might try kalydeco without safety risks and will continue treatment only when effective. so why not give them that chance, they don't have alternatives.

  • Reply to

    questions

    by papaalien2000 Feb 6, 2016 6:18 AM
    papaalien2000 papaalien2000 Feb 9, 2016 12:04 PM Flag

    VRTX has not disclosed what additional data FDA has requested. Given the small patient numbers it will be impossible to conduct meaningful classical phase III studies. So I assume it is something else that is missing, especially since VRTX has stated that FDA is willing to consider approval for sNDA for orcambi without phase III data, unlike European authorities that insist on phase III for orcambi sNDA Less

  • Reply to

    How much is thing worth in a buyout?

    by garroty Mar 9, 2016 1:22 PM
    papaalien2000 papaalien2000 Mar 10, 2016 11:46 AM Flag

    I agree that a take-over is highly unlikely. Guess, all of us don't understand why VRTX has lost one-third of its value in the last few months. There have been no negative setbacks that might explain the drastic loss in value.

  • papaalien2000 by papaalien2000 Mar 16, 2016 3:45 AM Flag

    why is VRTX participating in such conferences when they have nothing to talk about, but potential drop-out rates for orcambi? Such discussions will not enhance investors trust in the company.

  • Reply to

    Barclays Healthcare Conference

    by papaalien2000 Mar 16, 2016 3:45 AM
    papaalien2000 papaalien2000 Mar 17, 2016 7:51 AM Flag

    is it really a worthwhile effort to highlight potential problems of the lead product? VRTX ought to focus on the big picture: sales potential iva and orkambi, VX-661, second gen. compounds, non cf pipeline etc.
    Right now VRTX keeps providing the impression that it is facing problems with orkambi. The sp reacts accordingly.

  • Reply to

    God, what is going on?

    by whtthefk Mar 23, 2016 12:20 PM
    papaalien2000 papaalien2000 Mar 24, 2016 8:55 AM Flag

    VRTX refusal to issue forecasts for sales of Orkambi has contributed significantly to investors uncertainty. Highlighting potential drop-out rates for patients on Orkambi has confused investors, too. Next CC with quarterly sales of Orkambi in April may bring some clarity. Until then I expect more volatility in sp.

  • Reply to

    Leiden should be fired

    by gladpick Mar 29, 2016 2:04 PM
    papaalien2000 papaalien2000 Mar 31, 2016 7:04 AM Flag

    q, VRTX pipeline certainly would warrant a higher share price, but fact is, VRTX has lost much more value than its peers. So there must be specific reasons. In my opinion it is the lack of forecast for Orkambi sales. Management indicates that in real life application Orkambi might not be as good as expected. VRTX needs to give reliable forecasts for Orkambi, if they do not provide that guidance the sp will continue to decline.

  • papaalien2000 by papaalien2000 Apr 4, 2016 12:13 PM Flag

    Orkambi: Investors can't seem to reach a consensus trajectory for the drug's early launch, except that it's been slower than everyone first believed it would be.
    The sell side and the buy side already have cut Orkambi sales estimates this year. The worry now is that another downward revision might be necessary if Vertex's first-quarter earnings coming later this month come up short.

VRTX
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