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Myrexis, Inc. Message Board

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  • jacosa jacosa Nov 5, 2010 2:00 PM Flag

    Market has spoken...

    For relapsed GBM, long-term survival is 6 months (typical is a bit less than 2). That is exactly why the business goal is to establish Azixa as a salvage treatment for GBM.

    Relapsed melanoma with brain involvement is somewhat less immediately fatal, but again, a 2-year study would have precious few survivors in a "best conventional treatment" control arm. Preliminary results are a little less dramatic for Azixa here, too. A fairly plausible course would be for FDA to allow compassionate use (=no profits) of Azixa against relapsed GBM (GBM families could get real feisty on the basis of a good 2b result) while a real phase 3 was done against melanoma. If Azixa gained approval against melanoma, GBM could be included on-label on the basis of open-label results against a historical control. Funny stuff happens around miracle drugs, and so far, for GBM, Azixa looks like a miracle drug (half of patients respond, responders live more than 4 months and there's a multi-year survivor. And by the way, this was before dosing was changed to reduce deadly side effects).

    The rule of thumb seems to be that a phase 3 costs about $100MM a year. That is well within the resources of MYRX.

    Again: neither of these illnesses is the real business target. But the first goal is to get the drug onto the market.

    There is no need for Myrexis to manufacture the drug themselves, and selling expenses are modest for a drug used initially in tertiary-care settings.

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    • >>For relapsed GBM, long-term survival is 6 months

      I believe the goal of phase IIb is to position Azixa + Temodar as a first-line treatment, so it will take at least 2 years. They will have to show that the combo will do better than Avastin's combo.

      >>The rule of thumb seems to be that a phase 3 costs about $100MM a year. That is well within the resources of MYRX.

      $100M is pretty much all they have. Drug development is a very very risky business. It's reckless and UNBELIEVABLY STUPID for them to bet all on 1 drug. One would hope that management still remember the Flurizan lesson.

    • agreed. but the intent of management, after realigning the model, is to partner all their drugs. so they will take them far enough to prove its value/mkt opportunity, then partner. the first one will likely be their nampt drug. the second is a toss-up, but my guess is their hsp drug.

      they will never spend that kind of money on one drug. maybe all 3 over the course of 2-3 years. but keep in mind the partnership money will come in, and probably some this year, and some next.

      on azixa, all the big boys are circling, but they are waiting for 2b data, as they should. if she hits, the stock is gone. if not, we should do well with the other 2. this is to say nothing of new compounds coming out of the lab.

      most people hate this stock, because the company doesn't hype it. that's fine with me, i buy stock nearly every day. though i wish they did more, there's really not much they can do.

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