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Seattle Genetics, Inc. Message Board

fib1_1_2_3_5 6 posts  |  Last Activity: 41 minutes ago Member since: Dec 8, 2000
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  • Reply to

    Discontinued Trials After Fast Track

    by will-ping 49 minutes ago
    fib1_1_2_3_5 fib1_1_2_3_5 41 minutes ago Flag

    It is very common. Fast track says nothing about odds of success. Off the top of my head:

    PPHM's SUNRISE trial failed for futility a few months ago with Fast Track
    CLDX's Rindopepimut failed for futility a few months ago with break through designation (an enhanced version of fast Track).

    The designations mean that the drug, if it works, would be a significant improvement in a serious condition. They do not say anything at all about high likely it is the drugs will work.

    Hopefully you have learned not to byte on the fast track (or orphan) hype.

  • fib1_1_2_3_5 fib1_1_2_3_5 Jun 9, 2016 7:51 AM Flag


    . If you have sold the stock, it is a cap gain in the year you get the check.

    . if you have not sold the stock, it adjusts the basis and will factor in when you sell.

  • Reply to

    BIN data reveal

    by nptimothy May 19, 2016 1:12 AM
    fib1_1_2_3_5 fib1_1_2_3_5 May 19, 2016 9:33 AM Flag


    The 5.5 vs 1.6 data is in the N=85 subgroup who had 1st line immo agents, not the ITT population. This is important because one would expect such to be almost all prior treatment in the future. This should certainly help uptake once approved.

    Also, all the listed subgroups were solid on PFS.

    ORR came in at 15% vs 7%.

    The preliminary OS was trending at an HR of .81, kind of "meh", hopefully this number can improve a bit with age.

    Submission next month. Hopefully a fast turn by the FDA might see an approval by about EOY (ok, I know one should never expect such).

  • fib1_1_2_3_5 fib1_1_2_3_5 May 2, 2016 3:04 PM Flag

    The '8689 trial is single arm.

    PFS can be used (in some indications) with a controlled trial because one can compare X months to Y months and see how much better the new drug is.

    In a single arm trial, what does PFS mean? Is 8 months good? Bad? Who knows? Historical comps are meaningless, so there is no becnhmark.

    An approval based on a SINGLE ARM trial with PFS would be total BS. And such in the US/EU/Japan would simply never happen.

  • fib1_1_2_3_5 fib1_1_2_3_5 May 2, 2016 1:38 PM Flag

    Admittedly I do not follow the S Korean drug development scene, but this sounds like a bunch of nonsense.

    . The trial closed enrollment a few months ago, and the primary endpoint is +12 months. So early next year for data, and that is what is posted.

    . PFS for a single arm trial would not be considered for approval by any legit body. Basic issue is that one can not compare time based data to historical norms, and w/o such there is nothing to go on.

    . Changing the N well into an open label trial is more than a minor problem.

    Oh, the drug might well be approved over there. But this would say more for Hanmi's family ties than the strength of clinical evidence.

  • fib1_1_2_3_5 fib1_1_2_3_5 Apr 6, 2016 11:18 AM Flag

    Those who continually mouth inane comments about hedge fund manipulation and naked shorting should probably stick to investing in large diversified funds.

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