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Exelixis, Inc. Message Board

  • dclegal531 dclegal531 Apr 23, 2013 12:43 PM Flag

    What schrewed this company up

    what schrewed this company up was that EXEL failed to get a special protocol assessment from the FDA as to Comet 1 and 2 - or this is what I am told - Does anyone agree? or is EXEL gambling that the results in Comet 1 and 2 will "be enough" to win over the FDA - Does anyone know what impact the trial will have without SPA FDA ? Or is this current trial design "OK"?

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    • Pain as endpoint makes sense, if we run this as Phase IV after it gets approval and that will help us with marketing. But the management started the COMET-2 first, and gave up SPA for COMET-1. Finally started COMET-1 without SPA. Wasting too much resource(time, money, enrollment, etc) on COMET-2, had to sell shares cheap to GS.
      As we can always see, bad management screwed good science. Let him go before too late.

    • $$$$
      What follows is a copy & paste of an erniewerner post from Dec 2012... The MB won't permit me to post it in it's entirety, but I encourage you to find it and read it....

      "I want to return to this again because I think it is important. Failure to reach agreement on a 306 SPA was a rejection of a specific protocol, not a wholesale rejection of a pain endpoint.
      First, let's talk about the SPA process. In it the FDA provides its current thinking on what it will take to get a drug approved by means of a specific trial protocol. By agreeing to a SPA they are saying that if you dutifully conduct this trial in compliance with the protocol and it acheives its primary endpoint, we would approve the drug today and in the absence of any developments that would invalidate the present landscape, we would expect to approve the drug at trial completion. Obtaining a SPA is not mandatory and in fact most phase 3 trials are not conducted under the auspices of a SPA. The advantage for the sponsor is obvious, it essentially removes the risk of a future FDA criticising the trial design and denying approval on that basis. With this in mind, FDA steers a very conservative approach in its SPA negotiations as it does not want to put limits on itself that it may regret later. By agreeing to a SPA they are also acknowledging that the efficacy required for approval is attaining the minimum efficacy needed to attain the primary endpoint.
      Pain endpoints in oncology are controversial because the means of demonstration is highly subjective. Statisitically measuring subjective outcomes is prone to influences that can skew the result..."

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