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vskomarovsky 33 posts  |  Last Activity: Nov 24, 2015 2:07 PM Member since: Feb 9, 2006
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  • vskomarovsky by vskomarovsky Nov 24, 2015 2:07 PM Flag

    by pardontheinterruption • 4 hours ago

    No need to guess the FDA decision. Just read their briefing document and public statements prior to this meeting today. This is as negative as the FDA gets prior to meeting for approval. My guess, stock trades between $68 and $72 when trading resumes. FDA gives BMRN "Cold Turkey" treatment and CEO cries fowl.

    Sentiment: Strong Buy

  • Reply to


    by bionerd51 Nov 22, 2015 7:24 PM
    vskomarovsky vskomarovsky Nov 24, 2015 2:29 AM Flag

    ru., agree you're wrong - and your mental pain will vanish.

  • Reply to

    AdCom 8am-5:30pm

    by stocktrooth Nov 23, 2015 8:49 PM
    vskomarovsky vskomarovsky Nov 23, 2015 10:59 PM Flag


    The committee will discuss new drug application (NDA) 206031, drisapersen solution for injection, sponsored by BioMarin Pharmaceutical Inc., for the treatment of patients with Duchenne muscular dystrophy with mutations in the dystrophin gene that are amenable to treatment with exon 51 skipping as determined by genetic testing.

  • Reply to

    Anyone think...

    by stockpick423 Nov 19, 2015 6:25 PM
    vskomarovsky vskomarovsky Nov 19, 2015 9:09 PM Flag


  • vskomarovsky vskomarovsky Nov 18, 2015 1:30 PM Flag


    WHY SRPT Stock Collapsed
    Two things have happened.

    First, in an odd twist, the date expected for the FDA committee to meet was Nov. 23 and 24th and all parties believed that both BMRN and SRPT would both be reviewed on those days so the FDA could get a real handle on the two drugs and certainly approve at least one.

    But... It turned out BMRN will in fact meet with the FDA committee on Nov 23rd, but SRPT has been bumped to Jan. 22, 2016. That's not because the drug is less promising. Nothing has changed and tentative FDA schedules surprise people all of the time. In fact, by most accounts, SRPT's drug candidate is far superior to BMRN's.

    However, the fact that SRPT has been bumped back crushed the stock and does smell, even if it sounds paranoid, of some back channel FDA committee agreement. Parent and doctor advocacy groups almost immediately protested the date change, not because of the stock price, but because of the dire need for the medicine for children.

    Do you thrive on really understanding what's going on? Try free news alerts from us.

    The oddity and potential smoking gun of impropriety here is that the FDA committee had a wonderful opportunity to listen to and examine the data behind the only two drug candidates in the world to treat this disease at the same time, and make a recommendation based on all the data. But they didn't... and SRPT stock got hammered.

    Second, SRPT offered 3.25 million shares in a public offering at $39 per share. Sarepta plans to use the net proceeds from the offering for product and commercial development and general corporate purposes. That's a good thing.

    The main stream media simply doesn't have the lexicon to understand breaking biotechnology. It just doesn't. Get free news alerts (once a day) from us and you will be the expert in the room.

    THE Bizarre Over Reaction
    The market punished SRPT because its drug (if approved) will be two-months behind BMRN for release. Friends, this is a public company with a remarkable drug that will likely get approved and two-months means nothing to the stock price. This is not a one-time drug sale, it's a magnificent pipeline and treatment with decades of sales ahead of it. But again, all evidence points to SRPT having a superior drug, why has this date change happened, anyway?

    Even more bizarre, the PDUFA date (not the committee hearing date), which is the date that the drug gets an actual approval or disapproval status, was always going to be two-months behind BMRN. This was a known entity for now more than three-months and was never disputed. Yes, this two-month gap has always been known. I quote myself from the prior article in September:

    "BioMarin Pharmaceutical (BMRN) also has a drug under FDA review called drisapersen (from Prosensa in acquisition). Interestingly, Drisapersen's PDUFA date is Dec. 27, 2015 two months before SRPT gets its big day."
    Source: A Small Cap Biotech Ready to Explode

    The main stream media simply doesn't have the lexicon to understand breaking biotechnology. It just doesn't. Get free news alerts (once a day) from us and you will be the expert in the room.

    Since the PDUFA date was already behind BMRN, the changing of the dates for SRPT's FDA committee hearing feel yet more manipulated; in the bad and potentially illegal way.

    DETAILS about SRPT and its Drug
    Sarepta Therapeutics is a biopharmaceutical company that has no products out to market and no revenue, but has a market cap of $1.2 billion.

    SRPT has a drug candidate called eteplirsen that addresses Duchenne muscular dystrophy (DMD), a rare disease that affects the protective sheath surrounding muscle fibers and it's fatal.

    The FDA announced that it had in fact accepted Sarepta's new drug application filing for eteplirsen, granting it priority review status and setting its PDUFA decision date for Feb. 26, 2016. "Priority Review Status" is designated to drugs that offer benefit over existing therapies, or provide a treatment where no adequate therapy exists.

    It takes more than clickbait to understand breaking technology and biotech. Get free news alerts (once a day) from us and you will be the expert in the room.

    SRPT has had its ups and down, seeing its stock price trade as low as $11 and as high as $37 in the last year, alone. It's management appears to have totally botched an advisory committee request and in a rather unusual moment, the FDA itself clarified its points on the development timeline. But after a very (very) long trial for its DMD drug, things look good. When I say "good," I mean, it has reached the final endpoint and the data looks promising.

    An FDA advisory committee will judge the drug and the FDA will take that into account and make a final decision. The addressable market for this drug has been estimated to be about $700 million in sales which isn't quite blockbuster status, but it's a non-trivial win if it goes through and the $1.2 billion market cap as of today would represent less than a 2:1 price to sales. SRPT would instantaneously become a takeover candidate for any number of mega cap biotechs.

    The stock drop of off the FDA committee date change both apprears to be a bizarre over-reaction and feels like a nasty case of potential tampering with the FDA process. :

  • On November 17th, Sarepta Therapeutics revealed that a peer-reviewed medical journal, the Annals of Neurology, published the results, some of which had been announced, from a midstage trial testing its treatment for a fatal form of muscular dystrophy (Source: WSJ). The stock is finally rising after a catastrophic drop.

    The study found that at three years of treatment, patients experienced a slower rate of disease progression when compared to untreated matched historical controls and the investigational drug continued to be well-tolerated.
    Source: BusinessWire

    In English, SRPT is on the clock for an FDA committee meeting on January 22nd to recommend its drug to treat Duchenne muscular dystrophy (DMD), a disease which affects around 1 in 3,600 boys, which results in muscle degeneration and premature death.

    There are no cures or treatments available but SRPT has one and so does (maybe) BioMarin (BMRN). The incredible story is included below, and it's not only mind blowing, it may point to FDA member tampering, malfeasance and an incredible opportunity.

  • Reply to

    PPMD Pat talk

    by alt225alt225 Nov 16, 2015 11:44 AM
    vskomarovsky vskomarovsky Nov 16, 2015 12:07 PM Flag

    Not only' absolutely WRONG', but also absolutely DANGEROUS. If drisa were used and the damage is obvious - than it's absolutely CRIMINAL.

  • Reply to

    Screaming? WAILING BUY.

    by vskomarovsky Nov 6, 2015 10:50 AM
    vskomarovsky vskomarovsky Nov 7, 2015 1:30 AM Flag

    The decline was sudden. Bottom will be determent by the end of November. From there it will go up.
    (If FDA holds it's negative view on BMRN.)

  • vskomarovsky by vskomarovsky Nov 6, 2015 10:50 AM Flag

    After all data, news and the recent stock manipulations Sarepta is ROARING BUY.

  • Today, Kaye said that in all trials of the drug to date, which includes a much-larger confirmatory trial than just began as well as older and younger boys — more than 100 patients in total — none have discontinued treatment, and no serious side effects have ever been reported.

  • vskomarovsky vskomarovsky Nov 5, 2015 1:16 PM Flag

    From the same article - Simeonidis — the most skeptical of the three analysts as to the market potential for Sarepta’s drug — said that soon after drisapersen is approved, he believes “the majority of patients will be on it.” He also said many patients will stick with it, even if eteplirsen is approved later, but that over time, “there definitely will be patients and doctors who switch” to eteplirsen due to side effects.

    BioMarin, contacted for this story, has not provided comment on the safety profile of drisapersen. Drug companies with approval pending at the FDA often decline comment on their drugs. I will update this story with the company’s comments if they provide them.

    All three analysts told me their opinions before this morning’s conference call with Sarepta, which only confirmed the safety profile of its drug. Previously, eteplirsen’s safety record has been mostly based on the one 12-patient trial. Today, Kaye said that in all trials of the drug to date, which includes a much-larger confirmatory trial than just began as well as older and younger boys — more than 100 patients in total — none have discontinued treatment, and no serious side effects have ever been reported.

    By contrast, several patients taking drisapersen have had to stop for safety reasons over the years. In November 2013, when the drug was in trials by GlaxoSmithKline in partnership with Netherlands-based Prosensa (which BioMarin bought last year), GSK’s Global Medical Affairs leader Rohit Batta disclosed at a conference that four patients (out of a trial of 180) treated with drisapersen had to be hospitalized due to thrombocytopenia (low blood platelets) and several more were hopitalized for “severe proteinuria” (protein in the urine). (Batta himself addressed the fact in a blog post two years ago on the Parent Project Muscular Dystrophy website) While proteinuria alone is not a serious concern, it can be a sign of liver problems. In addition, many patients have reported reactions where the drug is injected.

  • With an FDA showdown approaching for two drugs to treat Duchenne muscular dystrophy, three experts say that Cambridge’s Sarepta Therapeutics has clear advantage over its direct competitor due to fewer side effects reported with its drug.

    On Nov. 24, an FDA advisory committee will meet to vote whether to recommend a drug by California-based BioMarin Pharmaceuticals (Nasdaq: BRMN) for U.S. approval. An approval decision is likely before the end of the year. The meeting for Sarepta (Nasdaq: SRPT), meanwhile, will be in mid-January. That means by next February — the FDA’s deadline to approve Sarepta’s drug — U.S. patients with a specific gene mutation in exon 51 could have a choice between two drugs to treat the disease. There are currently none available.

  • Reply to

    I am handling the srpt call tomorrw

    by simp08801 Nov 4, 2015 12:30 PM
    vskomarovsky vskomarovsky Nov 4, 2015 2:25 PM Flag


    You've dug the trench between Sarepta investors and the charity. You hate what we, investors, do, and we indifferent to you and your foreboding. You have a ZERO of well-wishing for Sarepta's children.You're 'IGNORED'

  • vskomarovsky vskomarovsky Nov 3, 2015 12:05 AM Flag


    If you mention Biomarin Pharmaceuticals (BMRN - Get Report) to buyside health care investors, it takes just minutes for the conversation to steer to "the letter." And then a question:

    Based on the letter's contents, is Biomarin headed for trouble when an FDA advisory committee meets in three weeks to review its drug drisapersen?

    The letter was written in June 2014 by Dr. Billy Dunn, a top official at the U.S. Food and Drug Administration. In it, Dunn expresses doubt about the clinical data collected to support the approval of drisapersen as an experimental treatment for Duchenne muscular dystrophy, a genetic muscle-wasting disease.

    Drisapersen is the most advanced and important drug in Biomarin's pipeline today. Approval of the drug in the U.S. and Europe could add $1 billion or more in revenue to Biomarin's top line and propel its stock price higher. Shares of Novato, Calif.-based Biomarin were slipping 0.5% to $116.44 Monday, trimming its 2015 advance to 29%.

    Dunn's letter raises important questions about drisapersen, though it wasn't entirely negative. He also laid out a strategy by which the drug could be submitted to the FDA for review and perhaps win approval.

    Has Biomarin followed Dunn's drisapersen advice? From the outside, it's not entirely clear. That's why investors tracking the company and drisapersen have been reading and re-reading Dunn's letter as it makes its way around Wall Street. Companies ignoring the FDA's rules or suggestions often find themselves later dealing with the painful consequences of a rejected drug.

    Biomarin Chief Medical Officer Hank Fuchs addressed investor worries about the Dunn letter on the company's quarterly conference call last week. In Biomarin, investors should just trust management, he said.

    "Biomarin knows what's it's doing," said Fuchs, emphasizing the company knows how to win FDA approval for rare-disease drugs like drisapersen.

    That trust will be put to the test on Nov. 24 at the FDA's advisory committee meeting.

    "In total, the clinical evidence of efficacy of drisapersen for the treatment of DMD appears to be inconclusive based on our preliminary review of the studies conducted, both in the intent-to-treat populations and in various post-hoc subgroup analyses," said FDA's Dunn in his June 2014 letter to Prosensa, the Dutch biotech firm which owned drisapersen at the time.

    One month earlier, Prosensa executives had met with officials at the FDA seeking guidance about a drisapersen approval filing. The problem: Drisapersen had failed to demonstrate a benefit in a crucial six-minute walk test compared to a placebo in a large, phase III clinical trial of DMD patients. Prosensa sought FDA advice because it believed flaws in the design of the phase III study -- conducted by former partner GlaxoSmithKline -- prevented drisapersen from showing positive results. In contrast, data from smaller, mid-stage studies showed drisapersen improved muscle function in Duchenne patients and helped them walk longer.

    At the FDA meeting in May 2014, the company argued that drisapersen data from four clinical trials, pooled together, showed that the drug worked and should be considered as the basis for approval. But before investing time and money necessary to put together a regulatory submission, Prosensa went to the FDA to gauge its feelings.

    "We find some of your hypotheses about factors that might have led to a lack of statistically significant findings in the Phase 3 study (DMD114044), in contrast to the nominal findings in earlier studies, plausible but not conclusive," wrote Dunn in the letter. "Although we have discussed with you our reservations about the persuasiveness of the available data, we are open to filing an NDA [New Drug Application] for drisapersen for consideration under an accelerated approval pathway (assuming the submitted application otherwise meets the applicable standards). As we are sure you appreciate, however, our willingness to consider an application for filing cannot be taken to suggest the outcome of our review."

    To present a more convincing case to the FDA for drisapersen's accelerated approval, Prosensa was "strongly urged" to conduct and submit additional data analyses from previously conducted clinical trials, according to Dunn's letter. The accelerated approval pathway for drisapersen would also require Prosensa to conduct additional confirmatory studies. In his letter, Dunn told Prosensa to move quickly to get these new studies started because initial data could be invaluable to the agency's review.

    "Stressing that we have not determined whether an application for drisapersen would be approved, any accelerated approval would require confirmatory studies to verify the clinical benefit. Confirmatory studies should be underway at the time of approval. We envision two approaches for confirmatory trials, and we urge you to initiate both of these trials as soon as possible," wrote Dunn. [Emphasis his.]

    Before Prosensa could act on the FDA suggestions for drisapersen laid out in the June 2014 letter, Biomarin swooped in to acquire the company for $850 million in November 2014. When the deal closed months later, the future of drisapersen became Biomarin's responsibility.

    Biomarin submitted drisapersen to the FDA and expects an approval decision to be made on Dec. 27. The FDA is convening an expert panel on Nov. 24 to review the drisapersen data. The panel will consider Biomarin's submitted drisapersen data and weigh that against the interpretation of the data presented by the FDA. At the end of the meeting, the experts on the panel will vote to recommend drisapersen's approval or not.

    In the weeks leading up to the Nov. 24 FDA advisory panel, investors are debating whether or not Biomarin conducted additional analyses of data compiled from the studies conducted by Prosensa that would satisfy the agency's concerns as described in Dunn's June 2014 letter. On its quarterly conference call last week, Biomarin says new drisapersen analyses were submitted to FDA and will be presented by the company on Nov. 24.

    But Biomarin has not started the two confirmatory clinical trials of drisapersen suggested by FDA in Dunn's letter to Prosensa. [Sarepta Therapeutics (SRPT - Get Report) , also seeking FDA approval for a competing DMD drug, has started a confirmatory trial.]

    When asked to explain why the new drisapersen studies have yet to begin despite FDA's strong urging, Biomarin's Fuchs, speaking on last week's conference call, said:

    "We've made a lot of preparations for what that confirmatory program could be, but we don't want to initiate enrollment into a confirmatory study until we're sure that we have the issues that are in consideration addressed in a confirmatory study. Now I should also remind you that we have ongoing a very large natural history study, reported some preliminary results to that in April at the American Association of Neurology. So we're already accumulating prospective natural history data on patients. And we clearly have been in discussion with the Food and Drug Administration about the nature of next steps of studies. We don't have anxiety about where we stand in regard to pulling the trigger, if you will, on a confirmatory study."

    Biomarin CEO Jean-Jacque Bienaime added, " And if may, I mean, correct me if I'm wrong, Hank. But I mean, so far, we've never heard from the FDA that inititation of the confirmatory trial was a prerequisite for approval of the drug."

    To which Fuchs replied, "That's correct."
    The FDA's June 2014 letter to Prosensa suggests otherwise. The controversy will be cleared up on Nov. 24.

  • Reply to

    How do I block someone?

    by stocktrooth Oct 30, 2015 12:21 PM
    vskomarovsky vskomarovsky Oct 30, 2015 12:44 PM Flag

    Click on Flag and than on
    'ignore user'

  • Reply to


    by devilsyankeefan Oct 22, 2015 2:15 PM
    vskomarovsky vskomarovsky Oct 29, 2015 9:54 PM Flag

    It doesn't matter - he's disoriented.

  • Reply to

    FDA Oct meeting

    by nino_tko Oct 29, 2015 8:15 PM
    vskomarovsky vskomarovsky Oct 29, 2015 8:29 PM Flag

    Wait until the quarterly on November 5.

  • Reply to

    Any playtime targets out there?

    by bf109gee Oct 28, 2015 11:43 AM
    vskomarovsky vskomarovsky Oct 28, 2015 3:32 PM Flag

    Respectfully, Conformis is a target of dozens of lawyers. Lawsuits being investigated by former orthopedic executive.

  • 10/23/2015 Bank of America Initiated Coverage Buy $49.00
    10/22/2015 Jefferies Group Initiated Coverage Hold $28.00
    10/17/2015 Oppenheimer Reiterated Rating Buy $45.00
    10/16/2015 Roth Capital Reiterated Rating Buy $50.00
    10/9/2015 Oppenheimer Reiterated Rating Outperform $45.00
    10/5/2015 Cowen Reiterated Rating Market Perform
    10/4/2015 Piper Jaffray Reiterated Rating Buy
    10/2/2015 Robert W. Baird Reiterated Rating Buy $47.00
    10/2/2015 Wedbush Upgrade Neutral - Outperform $56.00
    10/1/2015 Needham Reiterated Rating Buy $38.00 - $55.00
    10/1/2015 Roth Capital Reiterated Rating Buy $50.00
    9/30/2015 William Blair Reiterated Rating Buy $43
    9/28/2015 Oppenheimer Reiterated Rating Buy $45.00
    9/3/2015 Roth Capital Reiterated Rating Buy $50.00

105.45+0.04(+0.04%)Nov 27 1:00 PMEST