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Sarepta Therapeutics, Inc. Message Board

bionerd51 98 posts  |  Last Activity: Apr 17, 2014 11:25 AM Member since: Jan 2, 2007
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  • Reply to

    can u smell

    by starfe11 Apr 17, 2014 10:46 AM
    bionerd51 bionerd51 Apr 17, 2014 11:25 AM Flag

    hwsimpsonhero, Parents may believe Drisa "works" but a PhaseIII trial, run by GSK, says it doesn't help these kids. No stat. sig in 6MWT and dystrophin was so low they decided not to measure it. If Prosensa tries to file an NDA on a subgroup cohort and the FDA allows them to the FDA would be approving a drug that doesn't work and that subgroup would have less than 12 patients enrolled. This would be a complete double standard by the FDA. Disallowing an eteplirsen NDA filing with stat. sig. endpoints but approving a toxic drug with a smaller "N" that doesn't work. This would be official gov't malfeasance.

    Sentiment: Strong Buy

  • Reply to

    New relevant technologies

    by jonmoulton Apr 16, 2014 12:47 PM
    bionerd51 bionerd51 Apr 16, 2014 2:50 PM Flag

    Copp, The muscle specific peptide is a PPMO. It's designed to initiate an ATP/ caveolae-mediated endocytosis specific for skeletal muscles.

    Sentiment: Strong Buy

  • bionerd51 bionerd51 Apr 9, 2014 11:49 AM Flag

    Mush, But you are an adult male, not a 7-9 year old boy.

    Sentiment: Strong Buy

  • bionerd51 bionerd51 Apr 9, 2014 11:45 AM Flag

    Agreed. Do we know anything about the target location of the biopsy? A biopsy from scarred, fibrous muscle tissue would not prove my hypothesis. I know the muscle type location is computer generated but I don't know if they attempt to sample inflamed, transitional tissue.

  • Reply to

    AA is over

    by pasteur420 Apr 9, 2014 12:06 AM
    bionerd51 bionerd51 Apr 9, 2014 11:20 AM Flag

    Ru, The FDA concluded that based on data from the GSK trial, not the Sarepta trial. This is why everyone except you are outraged over this FDA.

    Sentiment: Strong Buy

  • Reply to

    Information in advance

    by usagary1 Apr 9, 2014 10:15 AM
    bionerd51 bionerd51 Apr 9, 2014 10:40 AM Flag

    Are you alluding to TKMR or Sarepta? I never liked Tekmira but I still have a large position in Sarepta. I hope I'm wrong on SRPT.

    Sentiment: Strong Buy

  • Reply to

    Information in advance

    by usagary1 Apr 9, 2014 10:15 AM
    bionerd51 bionerd51 Apr 9, 2014 10:20 AM Flag

    Rico, I'm with you. TKMR investor's will learn that soon.

  • Reply to

    FDA Meeting...

    by bionerd51 Apr 8, 2014 9:13 AM
    bionerd51 bionerd51 Apr 9, 2014 9:52 AM Flag

    hwsimp, Yes. Based on what I'm hearing from investors who are much closer to this issue than I am. I'm hoping the FDA has a late change of heart but then again the FDA is heartless.

    Sentiment: Strong Buy

  • bionerd51 bionerd51 Apr 9, 2014 9:40 AM Flag

    JRRT, I'm not sure Lu had access to the last biopsy data at the time of his article. If one takes into consideration the latest research that suggests that all oligos enter myocytes via myogenesis in the DMD pathology, a biopsy post 96 weeks should reveal greater/ + fibers/ total dystrophin. In the myogenic hypothesis low single digit number of cells undergo myogenesis due to injury, stress and/or inflammation every year. If true a 100% increase in total dystrophin in injured myocytes should be expected. There is one major flaw in the collection of these samples. Not every single-point sample is of inflamed muscle tissue. It is this tissue which undergoes myogenesis hence increased oligo myogenic cell entry.

    Sentiment: Strong Buy

  • Reply to

    AA is over

    by pasteur420 Apr 9, 2014 12:06 AM
    bionerd51 bionerd51 Apr 9, 2014 8:16 AM Flag

    The EU consortium is made up of Prosensa researchers and bureaucratic eggheads. Drisa produced single digit dystrophin [if that] in their phaseIII trial so they have an alternate motive to disprove the correlation between additional dystrophin and the 6MWT. This is what Prosensa is arguing with the FDA over as we speak. This EU consortium is advancing the home team goal of having the FDA approve Drisa. The EU and MHRA are the least objective of all the regulatory bodies.

  • Reply to

    FDA Meeting...

    by bionerd51 Apr 8, 2014 9:13 AM
    bionerd51 bionerd51 Apr 8, 2014 3:56 PM Flag

    JRRT, yeah. I remember that. He also stated that the FDA could revisit AA once initial data from P-3 came in.

  • Reply to

    FDA Meeting...

    by bionerd51 Apr 8, 2014 9:13 AM
    bionerd51 bionerd51 Apr 8, 2014 3:53 PM Flag

    br-rabbit, Long time….I have a feeling the FDA is going to serve sarepta. Starfe is correct in that the FDA has a hardon for CG. What I mean by that is full placebo cohort and +24 month drug period.

    Sentiment: Strong Buy

  • Reply to

    FDA Meeting...

    by bionerd51 Apr 8, 2014 9:13 AM
    bionerd51 bionerd51 Apr 8, 2014 3:50 PM Flag

    I agree with you. I posited best case scenario Vs. worst case. If I was the FDA commissioner I would place all exon 51 boys on eteplirsen right now.

  • Reply to

    FDA Meeting...

    by bionerd51 Apr 8, 2014 9:13 AM
    bionerd51 bionerd51 Apr 8, 2014 3:43 PM Flag

    How long was GSK's PhaseIII ???

    Sentiment: Strong Buy

  • Reply to

    FDA Meeting...

    by bionerd51 Apr 8, 2014 9:13 AM
    bionerd51 bionerd51 Apr 8, 2014 3:41 PM Flag

    Zwerp, The drug enrollment period. Not how long it takes to crunch data and file an NDA.

  • Reply to

    FDA Meeting...

    by bionerd51 Apr 8, 2014 9:13 AM
    bionerd51 bionerd51 Apr 8, 2014 3:30 PM Flag

    I believe a compromise would be good for the pps. A compromise is using non-exon 51 boys for the placebo cohort. Also look at the length of trial. 12 months would be very bullish for the stock. 18 months so-so.. 24 months would be a killer.

  • Reply to

    FDA Meeting...

    by bionerd51 Apr 8, 2014 9:13 AM
    bionerd51 bionerd51 Apr 8, 2014 3:24 PM Flag

    Needham & Company analyst Chad Messer confirmed to StreetInsider that Sarepta Therapeutic (NASDAQ: SRPT) did in fact cancel from the Needham Healthcare conference scheduled tomorrow.

    The analyst believes this is tied to an FDA meeting to discus the details of a confirmatory study for eteplirsen in Duchenne’s muscular dystrophy (DMD). On their last earnings call in late February Sarepta announced they expected to meet with the FDA in March. Sarepta was scheduled to present and do 1x1s with investors on Tuesday

    Sentiment: Strong Buy

  • Reply to

    FDA Meeting...

    by bionerd51 Apr 8, 2014 9:13 AM
    bionerd51 bionerd51 Apr 8, 2014 3:02 PM Flag

    Simp, Investor's called the company yesterday and was told that they cancelled their Needham presentation due to other commitments. What other commitments would keep SRPT away from a Needham conference???

    Sentiment: Strong Buy

  • Reply to

    FDA Meeting...

    by bionerd51 Apr 8, 2014 9:13 AM
    bionerd51 bionerd51 Apr 8, 2014 2:56 PM Flag

    I posited the fact that AA could still be granted after the start of the upcoming PhaseIII trial because that's what the FDA said after the Nov. meeting.

    Sentiment: Strong Buy

  • Reply to

    FDA Meeting...

    by bionerd51 Apr 8, 2014 9:13 AM
    bionerd51 bionerd51 Apr 8, 2014 2:41 PM Flag

    Simp, Needham came out with a blurb saying that Sarepta's meeting with the FDA conflicted with their Conference of April 8th. So the meeting was either today or tomorrow. One doesn't have to be Kreskin to know that the FDA is driving sarepta nuts over AA, P-3 trial design and surrogate endpoints. There was an article within the last 2 days that stated sarepta was looking for a compromise position with re: to the placebo cohort. The FDA's position was that a full placebo cohort of exon51 boy's had to be part of the trial design. Sarepta countered with a placebo cohort of non-exon 51 boys. Sarepta's position was cognizant of the families position that if their nonexon51 boys are enrolled in a placebo cohort they would be the first to start drug enrollment in the next exon to be tested. This was a compromise position and not my position. I believe a negative cohort is not necessary but if one was demanded by the FDA a historical one would be sufficient.

    Sentiment: Strong Buy

SRPT
24.40+0.17(+0.70%)Apr 17 4:00 PMEDT

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