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Rockwell Medical, Inc. Message Board

recessionfreep 9 posts  |  Last Activity: Feb 5, 2015 11:32 AM Member since: Sep 3, 2013
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  • Reply to

    So long Margaret

    by thigrlsrk Feb 5, 2015 5:09 AM
    recessionfreep recessionfreep Feb 5, 2015 11:32 AM Flag

    BioMarin is gonna want a refund from her.

    Sentiment: Strong Buy

  • Reply to

    Technically Speaking

    by bud_rolfs Jan 19, 2015 10:03 PM
    recessionfreep recessionfreep Jan 20, 2015 11:29 AM Flag

    Damn Bud, I said I was looking forward to your charts but now to hear we may test the $10 level is stomach turning lol. I hope your wrong because there's no way I wanna risk selling right now just to buy back cheaper shares. With my luck we'll get crazy good news while I'm out! Are you currently holding a position?

  • Reply to


    by bud_rolfs Jan 15, 2015 10:26 AM
    recessionfreep recessionfreep Jan 16, 2015 12:28 PM Flag

    Don't fade away Bud! I miss your posts, my first few times getting in and out of SRPT were timed close to perfectly for the biggest potential gains because of your ABC's.

    I got back in a few months ago with a $15.90 average. Looking forward to your updates.

    Sentiment: Strong Buy

  • recessionfreep recessionfreep Jan 15, 2015 11:21 AM Flag

    While the benefit of taking Eteplirsen remains cleared when compared to placebo/ delayed Eteplirsen groups of the experiments, the primary concern was the decline in the distance covered at week 168 as compared to week 144. This has refuted earlier assumptions that longer treatment periods with Eteplirsen continuously increased the benefits.

    The company also reported that all patients displayed a continued stability of respiratory muscle function. One of the important FDA requirements was that Sarepta provided clinical evidence that Eteplirsen actually increase the muscle protein dystrophin. The primary end point of this study was to provide evidence that Eteplirsen significantly increased the protein dystrophin. The study 202 met its primary end point in this regard. The week 48 muscle biopsy showed increased levels of novel muscle dystrophin.

    According to Jerry Mendell, (M.D. director of theCenters for Gene Therapy and Muscular Dystrophy at Nationwide Children's Hospital and principal investigator of Study 202)

    "With greater than three years of Eteplirsen experience, the clinical outcomes that our team has demonstrated in the testing of these boys exhibit greater stability in function than anticipated at a time when we often observe a more significant decline without treatment. Based on my many years of caring for patients with this devastating disease, I view these more than 3 years of data as very encouraging. The safety profile of Eteplirsen continues to impress me. We have not witnessed any clinically meaningful treatment-related adverse events during the 168 weeks of Eteplirsen treatment."

    DMD Industry Updates

    PTC Therapeutics (NASDAQ:PTCT) has also announced that it has started the rolling NDA for its nmDMD drug Translarna. The company plans to submit a rolling submission which would mean that it can submit the application in parts. The company expects to complete the NDA submission by the 4th quarter of 2015, after the completion of Phase 3 trials

    Sentiment: Strong Buy

  • Summary

    Sarepta has fallen to its 52 week low yesterday after the company announced more data from its DMD trial.
    The trial results show that the subjects have shown diminished ability to walk after 168 weeks as compared to 144 weeks.
    The company is optimistic about an approval for its drug and plans to submit an NDA in mid-2015, since the study has met the primary end points.
    Sarepta (NASDAQ:SRPT) has fallen to its 52 week low yesterday after the company announced more data from its DMD trial. The shares have fallen approximately 23% since the announcement; from around $15 per share to below $12 per share. In some bad news for the entire DMD community, after 168 weeks, the patients taking Eteplirsen displayed a diminished ability to walk as compared to week 144. In earlier observations, the duration of therapy had been directly porpotional to improvement in patient's walking ability. Despite this disheartening news for the larger DMD community, Eteplirsen met its primary end point of creating muscle protein dystrophin.

    The recent data from the Eteplirsen does limit its potential to help DMD victims but the study has still met its primary end point. The company has announced that it plans to file for an NDA in mid-2015. The success chances of this NDA are solid considering that the company has proven the formation of dystrophin, a previous concern of FDA. However, the declined ability to help patients after 144 weeks does limit the market potential of Eteplirsen.

    Please read my detailed take on Sarepta potential here and make all investment decisions after complete due diligence.

    Clinical Data

    The company has announced from its ongoing Phase II study for Eteplirsen. The data released was from 6MWT (6 minute walk test) after 168 weeks. After 168 weeks, the 6 boys taking between 30mg/kg and 50 mg/kg of Eteplirsen, showed a diminished ability to walk. The average distance covered declined by 76.6 meters or about 19.5%

    Sentiment: Strong Buy

  • (or extremely close to it). That's good news in my book, especially with all the "no green for SRPT until
    January" talk.

    Sentiment: Strong Buy

  • Reply to

    I am calling it

    by winterlion7722 Dec 23, 2014 3:21 PM
    recessionfreep recessionfreep Dec 23, 2014 4:41 PM Flag

    Forgive me if my question sounds clueless but how would that help us?

    Sentiment: Strong Buy

  • recessionfreep recessionfreep Dec 17, 2014 12:51 PM Flag

    Now that's a cool history lesson. I'm only half way through the bible and never saw this. Great post.

  • Sr. Director
    Director Medical Information
    Chemistry Associate, Quality Control
    Director, Corporate Communications
    Director, Investor Relations
    Chemistry Associate
    Scientist II, Muscle Biology
    Sr. Director, Global Technical Operations
    Senior Scientist, PMO Formulations
    Associate Director, Regulatory Strategy
    Patent Counsel/Senior Patent Counsel

    Cant imagine it'd be just fot #$%$'s and giggles.

    Sentiment: Strong Buy

10.15-0.13(-1.26%)10:21 AMEST

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