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Exelixis, Inc. Message Board

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  • wilderguide wilderguide Oct 21, 2011 1:17 PM Flag

    Downside risk?

    ...
    Should CABO field negative MTC results, I would expect the stock to respond by dropping down into the low $4's/high $3's on the ensuing irrational sell-off.

    I would view that as the buying opportunity of a lifetime. The MTC indication has little intrinsic value. All CABO's value will come to fruition in bone mets, prostate, breast, etc.

    Unfortunately, CABO's orphan status in MTC guarantees no certainties of FDA acceptance in the shadow of vandetanib approval.

    The SPA protocols on the 306 trial will likely determine how much value is retained should MTC toad southward...

    There will be a lot of attention paid following Thurs earnings report. Dr. Mike's got a mouthful of reporting to do...

    Time'll tell...

    GLTA

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    • I would agree that negative results in MTC would cast a shadow and the stock might drop to cash levels. There would have to be some impressive spinning to not have that be a major negative since independent of market, it appears to be about the best chance to see the drug work. Consider that the dosing was at a high dose, a dose that had impressive activity in the Phase 1/2 trial, and that a similar drug (vandetinib) has proven activity in that setting despite less impressive early data (and lack of the same sort of braod antitumor activity seen with Cabo). While it is possible that the high dose resulted in more withdrawals in the Cabo group, if there extreme differences in safety between the groups, the safety monitoring committee would have needed to bring it up. So, with a negative trial, the whole Cabo franchise would be put into question.
      As far as FDA, the fact that vandetinib is approved won't invalidate the SPA under which the MTC trial was done, but could result in less urgency from FDA to review things quickly.
      Of course it could be that EXEL doesn't want the MTC trial results unblinded until they know where things stand with FDA on the prostate trials so that they can potentially combine the news. Imagine the prostate SPA is disappointing but there is news of a positive phase 3 trial at the same time.
      It certainly makes for interesting times... waiting...

      GLTA,

      The "Wiz"

      • 1 Reply to oncodocbiotechwiz
      • OncoDoc,

        What's the reality of that scenario...??
        At the time the EXEL MTC SPA was acknowledged by FDA, MTC qualified as an unmet medical need.

        Since vandetinib approval, this has obviously changed... at least to the extent that unmet medical need no longer applies.
        You mentioned FDA urgency...
        Does this lack of urgency necessarily backburner EXEL's MTC program? How far into the future can they push a response...?? Especially if the results are comparable, as P2 trials had shown...??
        Would a definitive difference in mechanism of action become a requisite for approval...??
        Would there of necessity be a spinoff between Vandy & CABO...??
        GL TIA

 
EXEL
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