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Oncothyreon Inc Message Board

biomachine2006 7 posts  |  Last Activity: Jun 3, 2014 7:50 PM Member since: Nov 16, 2006
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  • biomachine2006 by biomachine2006 Jun 3, 2014 7:50 PM Flag

    Low pps, stagnant depressed PPS is all due to shorts???? LOL Yeah right! Market is tellin' you somethin' but you ain't listening.

    The trial will be a continue on interim. Data is too muddy to pass on an extremely difficult hurdle like OS with the stringent P value.

    PPS will likely sell off at that point due to perceived lack of robust activity. Pumpers will continue holding and pumping until the final result which will be a failure on OS.

  • Reply to

    Straw Poll

    by biomachine2006 May 28, 2014 2:09 PM
    biomachine2006 biomachine2006 May 28, 2014 3:28 PM Flag

    Ever wonder why they scrapped the PFS interim? Isn't PFS the easier endpoint? Hmmm....go after the more difficult OS but have to enroll an additional ~200 pts to "hopefully" see a difference at the end. Now ~200 pts enrolled from July - Dec. 2013 (6 months). Assuming even enrollment, that is a median time of only 12 months from Sept. 2012 to Sept. 2014. Not enough time to contribute to efficacy at the interim. More importantly, these "new" enrollees muddy the water further statistically which almost guarantees a miss on interim.

    The OS assumption used last July was based on a study that enrolled pts from 2002 to 2010. The OS during the period skewed higher over time, BUT the OS survival assumption for the 406 study is incorrect because it is based on median OS for the entire period and not the improved BSC that is available during the relevant enrollment period of 2010-1013. Some more recent publications point to this higher OS for STS pts.

  • Reply to

    Straw Poll

    by biomachine2006 May 28, 2014 2:09 PM
    biomachine2006 biomachine2006 May 28, 2014 2:50 PM Flag

    Control arm comes in at 15/16 at final.

  • Reply to

    Straw Poll

    by biomachine2006 May 28, 2014 2:09 PM
    biomachine2006 biomachine2006 May 28, 2014 2:49 PM Flag

    You're hilarious.

    The call to discuss the ASCO posters (early stage GBM and MM) is really nothing more than that. That's right just posters. Sunday cc has NOTHING to do with the 406 study. LOL Yeah right partnership. LOL On a Sunday evening when no one important (ie. Market) is really listening or paying attention.

  • biomachine2006 by biomachine2006 May 28, 2014 2:09 PM Flag

    Someone should a start a poll here for the STS.

    1. Who thinks the 406 study passes interim?
    2. Does the control arm OS come in higher than THLD's recently revised higher guess-timates?
    3. Does the 406 study pass at final?

    Starting it off.

    1. Misses on interim efficacy.
    2. Control arm comes in higher than THLD's guess-timate.
    3. Study fails.

  • biomachine2006 by biomachine2006 May 22, 2014 5:35 PM Flag

    There is absolutely no mention of anything on safety and/or clinical in terms of questions/responses to FDA. This appears to be solely in connection with the CMC section.

    This delay was expected considering how close the Keryx response to FDA was relative to the PDUFA date. There was no way FDA was going to respond in time.

    Sentiment: Strong Buy

  • Reply to

    Hmmm...

    by biomachine2006 May 8, 2014 5:34 PM
    biomachine2006 biomachine2006 May 22, 2014 5:21 PM Flag

    And there you go.....

    September 7th it is then.

    "Very likely that FDA on June 7th announces that the review and, hence, the PDUFA action date has been extended by 3 months to September 7, 2014.

    FDA usually takes it right down to the last possible day before making this public."

    "~80-85% chance of standard 3 month delay/push out of the PDUFA. Expect resolution in that new PDUFA window."

    Sentiment: Strong Buy

ONTY
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