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Sarepta Therapeutics, Inc. Message Board

hardfocus 5 posts  |  Last Activity: Jun 17, 2016 8:21 PM Member since: Nov 26, 2003
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  • Reply to

    Conclusion from GNCA presentation-

    by tmontagnino2 Jun 16, 2016 11:19 AM
    hardfocus hardfocus Jun 17, 2016 8:21 PM Flag

    The 12 month durability for HSV2 viral shedding, recurrences, and lesions is most impressive and makes it very promising for P-3 trial confirmation. Unique antigens and adjuvant Anybody on Valtrex or Famvir wuld likely get this therapeutic vaccine. pps should easily be back over $8 like it was when the news came out late March.

  • hardfocus hardfocus Jun 13, 2016 7:39 PM Flag

    This tech was tried in 2008 (Asklepios Biopharma) and resulted in auto-immune adverse reactions (published in NEJM in 2010). Anytime you give a live viral vector and potential for a foreign gene to create a mutant, there are safety issues. Lots of clinical trials and time will be needed by Bamboo to demonstrate safety (at least 5 yrs before ever gets FDA approval).

  • hardfocus hardfocus Apr 28, 2016 7:05 PM Flag

    A lot of people like yourself (and some even within FDA, like Dunn/Farkas crew) have not yet understood that FDASIA was intended to create a new class of drug approvals. These conditional approvals ("accelerated approval") would temporarily have a lower standards bar but eventually would need a confirmatory study otherwise be withdrawn from the market. You cannot compare this to historical standards. Expect to see many new FDASIA applications.

  • hardfocus hardfocus Apr 22, 2016 3:08 AM Flag

    You are wrong, and Bionerd is correct. FDA does lower the standard of evidence for a brief period of time until it is fully studied perhaps with some more endpoints (higher standard) in a confirmatory P-3 trial. That is the FDASIA law that Congress & the public intended. The problem is its uneven application within the various review divisions of FDA and the etep ruling - if negative - will be a major issue on review standards for the new FDA Commissioner. The world changes and FDASIA kicked it off ....time for everybody at FDA to adhere to the new process & standards.

  • Reply to

    One reason to get in now

    by boardofficer Apr 21, 2016 8:29 PM
    hardfocus hardfocus Apr 22, 2016 2:43 AM Flag

    Pfizer is on the hunt to expand their profitable vaccine biz and gen-herp vaccine is on their shopping list. Pfizer office in Cambridge too. The key is the unique Matrix-M adjuvant that makes this an exceptionally successful vaccine as seen in recent P-2 results.

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