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Sarepta Therapeutics, Inc. Message Board

mweathernw 15 posts  |  Last Activity: Dec 17, 2014 7:50 PM Member since: Oct 17, 2007
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  • Reply to

    For 3 years he sat on his

    by starfe11 Dec 17, 2014 7:17 AM
    mweathernw mweathernw Dec 17, 2014 7:50 PM Flag

    Ok. I am going to bite. Has the CEO announced that layoffs are coming? What is the basis for your prediction? I don't catch all the news. I probably missed this somewhere.

  • Reply to

    From christine today, "Please tell the board

    by thigrlsrk Dec 16, 2014 4:19 PM
    mweathernw mweathernw Dec 16, 2014 6:42 PM Flag

    Thank you for sharing. While as simp says, the stock market price is detached from clinical progress at the moment, it is a great comfort to know that there is not some unknown worst case scenario around the corner. Stable after 168 weeks is incredible.

  • Reply to

    8 recruiting sites

    by immediatereliefxxx Dec 6, 2014 7:12 AM
    mweathernw mweathernw Dec 6, 2014 5:34 PM Flag

    The RNA clinical strategy is bizarre. It's like they are trying to re-dose anybody over five years of age, seek approval on confusing and weak data, and instead of proving there drug works, rely on the principle it will take several more years to prove their drug doesn't work. By that time they will have recouped their investment. I mean, look at their confirmatory trial protocol. No further placebo. No dystrophin measuring. And continue to recruit basesline ages and walking distances where natural history on the 6 minute walk test isn't clearly defined. I don't think there is any way the FDA buys this strategy so long as Eteplirsen is available.

  • Reply to

    FromTwitter:

    by free_will_000 Dec 5, 2014 3:56 PM
    mweathernw mweathernw Dec 5, 2014 4:17 PM Flag

    When the anecdotal evidence comes from trial participants it means everything.

  • Reply to

    THIS IS A TOXIC CEO

    by starfe11 Dec 5, 2014 10:22 AM
    mweathernw mweathernw Dec 5, 2014 11:23 AM Flag

    Toxic? You know what is toxic? Every time i open up the message board and see one of your messages. And i have you on ignore. But even at that Yahoo still lets you through half the time.

  • Reply to

    Patent Infringement Drug Musings...

    by bionerd51 Dec 4, 2014 2:56 PM
    mweathernw mweathernw Dec 4, 2014 4:11 PM Flag

    Nice find. Please share it with the company in case patent attorneys overlooked it.

  • mweathernw mweathernw Nov 26, 2014 2:08 PM Flag

    The more you repeat yourself, the less sense any of your suggestions make. And what's the harm? That's your argument? Maybe the best answer is Wilton is busy doing important work in the lab to advance exon skipping and Garabedian and Kaye are quite capable of providing a full update for the parents on clinical trials that are underway.

  • Reply to

    From Seeking Alpha

    by free_will_000 Nov 26, 2014 7:55 AM
    mweathernw mweathernw Nov 26, 2014 9:11 AM Flag

    The FDA has not alleged any problem with any Sarepta manufacturing facility. In fact they haven't said they found any "problems" with anything other than they want independent verification of dystrophin quantification from the clinical trial. The main holdup is requiring another 90 days of satety data before the NDA may be submitted. That is the new arbitrary requirement that will delay the NDA 6 months. Everything else the FDA requested could have been satisfied by February.

  • mweathernw mweathernw Nov 24, 2014 7:51 PM Flag

    I appreciate the incremental updates. For me it shows that investor communications office is back on the job unlike the absolute drought last May thru August when we got almost nothing except sporadic disappointing news releases. In fact during that time, CG was skipping conferences while the Executive Office was in meltdown. I am getting the impression that the company is back on track now. Each of these conferences will have some new information and the DMD webinar will help clinical trial enrollment.

  • mweathernw mweathernw Nov 23, 2014 3:53 PM Flag

    This summer I got a letter from the FDA like many I am sure. They included with that letter a copy of the Sarepta April press release providing a pathway to an NDA submission by the end of this year. Further, Janet Woodcock referenced that Sarepta press release in her response to the Presidential Petition for Accelelerated Approval as evidence of the FDA urgency and flexibility. By the FDA's own communication they confirmed the guidance given to Sarepta for an NDA submission by the end of this year. The guidance was clear that the 168 week data and the fourth biopsy and independent biopsy analysis could be submitted AFTER the NDA submission. The purpose of the April guidance was to allow the review calendar to start as soon as possible. It was not guidance suggesting a rolling submission. A rolling NDA submission does not expedite the review calendar which the FDA also acknowledged with their recent press release. The purpose of the April guidance, of course, was also to deflect the political heat. That is is clear by how many times the Sarepta press release was touted by the FDA as evidence of their flexibility for DMD. As the heat subsided they have now changed the guidance this October causing a 6 month delay in the NDA. It is outrageous and the only proof of the arbitrary political intransigence of the FDA that advocacy groups need to present to Congress are copies of FDA's own twisting and winding communications.

  • mweathernw mweathernw Nov 14, 2014 5:44 PM Flag

    I think there has been some confusion what CG said on this subject. If you go back to the transcripts it is not that confusing at all. The moving goal posts caused the confusion.

    When the NDA was expected to be submitted by year end, he said he would consult with the FDA what new research data was appropriate to release while the review was underway.

    Until the NDA is filed, clinical results will continue to be released as they become available.

  • Reply to

    No news, no catalysts for a year

    by winterlion7722 Oct 27, 2014 4:10 PM
    mweathernw mweathernw Oct 27, 2014 4:32 PM Flag

    Maybe I am wrong. I just read grey's quote below. Is that a quote from today's call? I did not hear the call today. I had only listened to the previous calls and read today's release. If this is the CEO's quote from today it makes absolutely no sense to me. Why stop releasing updates on data available before the NDA is filed?

  • Reply to

    No news, no catalysts for a year

    by winterlion7722 Oct 27, 2014 4:10 PM
    mweathernw mweathernw Oct 27, 2014 4:26 PM Flag

    There is no longer a basis to think that biopsy results and 168 week data will not be released publicy. In a previous conference call, the CEO said the public release of the data would depend on how the FDA might feel about it while an NDA is under review. Now that we know this data will be available before the NDA application and review, I don't see any reason for delaying the public release. The only possible impediment to immediate public release has been removed. The significance of the data as a catalyst has been reinforced today. Judging by the timing of past releases this should occur in January 2015.

  • Reply to

    THE CEO IS 15 POINTS OF DAMAGED GOODS

    by starfe11 Oct 22, 2014 10:15 AM
    mweathernw mweathernw Oct 22, 2014 11:50 AM Flag

    The cool thing is that you are obviously moving your money to RNA and will be posting on that board hereafter.

  • Reply to

    CG better be remarkable on the next call

    by starfe11 Sep 30, 2014 10:47 AM
    mweathernw mweathernw Sep 30, 2014 3:18 PM Flag

    The CEO did not lie about anything in the last call. He provided a status on when new trial dosing was expected to begin. He said the end of October or a bit after. That was not changed in subsequent days although it got some negative press for being a delay from his guidance some months ago. We don't like the delay, but you are the one proving himself to be a liar.

SRPT
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