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Sunesis Pharmaceuticals, Inc. Message Board

biobuccaneer 7 posts  |  Last Activity: Apr 27, 2016 5:29 PM Member since: Jul 16, 1998
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  • Reply to


    by gladpick Apr 27, 2016 5:06 PM
    biobuccaneer biobuccaneer Apr 27, 2016 5:29 PM Flag

    The right to privacy in those communications is with SRPT. The FDA can't release them, but SRPT can. SRPT has no obligation to do so though because of their proprietary nature.

  • Reply to


    by gladpick Apr 27, 2016 5:06 PM
    biobuccaneer biobuccaneer Apr 27, 2016 5:26 PM Flag

    Those communications are considered proprietary and confidential. There isn't any disclosure requirement for SRPT, so no one can sue based only on that. Think of it as being the same as CRL communications.

  • Reply to

    Does Anyone Out there

    by pearsby09 Apr 26, 2016 5:18 PM
    biobuccaneer biobuccaneer Apr 26, 2016 5:45 PM Flag

    The Advisory Committee doesn't approve any drugs. It votes to suggest approval or disapproval of drugs leaving it for the FDA to act on. Usually the follow an Advisory Committee's recommendation, but rarely the FDA does go the other way.

  • Reply to

    Tomorrow SP guesstimate...

    by recessionfreep Apr 25, 2016 10:51 PM
    biobuccaneer biobuccaneer Apr 26, 2016 9:55 AM Flag

    Rather than 'playing with money' as you put it, why not treat this as an actual investment. Instead of buying more at $8 in defiant optimism, why not wait to see if the share price settles at $7, or $6, or $5. Being adamantly wrong is nothing to brag about. If the FDA stands by the decision of its Advisory Committee, it will be a couple more years before SRPT has a PDUFA date for this. That gives you plenty of time to be optimistic (and avoid the dilution that will come when SRPT raises money).
    The most likely outcome is the FDA requires additional trial data, which the FDA says it has been telling SRPT for some time. If you are going to treat an investment like 'playing with money', at least play the odds.

  • Reply to

    % Positive AdComm Vs. FDA Approval

    by ikbenjen Apr 22, 2016 10:24 AM
    biobuccaneer biobuccaneer Apr 22, 2016 11:18 AM Flag

    It means that 74% of the time an Advisory Committee supported approval, while 79% of the time the FDA did approve. Within that you have a minority of times the FDA did not follow the advice of the Advisory Committee (both for and against approval). The takeaway is the FDA typically follows its Advisory Committee but on rare occasions it does not. I would caution against talking yourself into the notion that the exception is the rule here.

  • biobuccaneer biobuccaneer Apr 22, 2016 9:52 AM Flag

    No one leaked. The FDA posts the briefing papers for Advisory Committees on their website in advance of the meeting, for the public to see. That's FDA policy and welcome transparency. That you and the current 11 people that gave you a thumbs up didn't know that tells me there are a lot of wannabe Warren Buffets in this stock that have no knowledge about this sector.
    Doing your due diligence, you didn't think to look at why the stock went down as much as it did in January? Oh wait, people like you don't do due diligence. It was for the exact same reason - the Advisory Committee briefing papers were posted to the FDA's website questioning the trial.

  • Reply to

    I've been long and I've been short SRPT

    by idioticshort Apr 21, 2016 3:37 PM
    biobuccaneer biobuccaneer Apr 21, 2016 3:42 PM Flag

    The drop isn't being 'driven by emotion' but by negative briefing papers by the FDA's Advisory Committee. SRPT will likely need to engage in further costly and time consuming trials. If today's drop weas for no reason I would agree with you, but there is a substantive reason for the drop.

0.47-0.02(-4.70%)May 26 4:00 PMEDT