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left2rightdoor 44 posts  |  Last Activity: 14 hours ago Member since: Jul 16, 2012
  • Man dies with suspected H1N1 infection

    Indore : Even as the District Health Department officials found a patient positive of H1N1 virus on Wednesday, another suspected Swine flu patient succumbed to his disease in MY Hospital on Thursday. A 30-year-old male, resident of Vijay Nagar, was admitted to the Swine Flu Ward of MY Hospital on Wednesday night in critical conditions. He condition was critical and he succumbed to his disease on Thursday. However, Integrated Diseases Surveillance Programme in-charge Dr GL Sodhi said, “The hospital administration informed us about the suspected patient but they didn’t send any samples of the patient.” He added that the condition of the patient, who was found positive, is still critical

  • left2rightdoor by left2rightdoor Aug 28, 2015 2:43 AM Flag

    What kind of analyst says early acceptance doesn't correlate with approval- an analyst who is surprised by the way the world of DMD is developing and has to be redundant with "slightly"

    ". We are slightly surprised of the slightly early acceptance, and believe it speaks well of the technical and administrative quality of the NDA, but no read through on approvability"

  • left2rightdoor by left2rightdoor Aug 27, 2015 4:37 PM Flag

    There was a prior British study with 19 participants, showed dystrophin related to dose ranging.

    Complete and extremely encouraging findings from a phase 1b-2 trial of eteplirsen (AVI-4658), an exon skipping drug in development to treat a portion of the Duchenne muscular dystrophy (DMD) population, show the compound is safe and well-tolerated, and that it can significantly increase production of the needed dystrophin protein in recipients without eliciting an unwanted immune response.

    The investigators say the results show eteplirsen has the potential to slow the progressive course of DMD and now needs to be investigated in longer clinical trials that can demonstrate functional effectiveness. A new trial is now open at Nationwide Children's Hospital in Columbus, Ohio, that will employ higher doses and a longer treatment duration than the U.K. trial did.

    Encouraging preliminary results for this 12-week trial plus an additional 12 weeks of observation were announced in April 2011 at an American Academy of Neurology meeting (see Exon skipping drug AVI-4658 [eteplirsen] results in dystrophin production in Duchenne MD trial, Quest News, April 20, 2011). However, limited information was available at that time.

  • Reply to

    Adcom Dates

    by greyzone513 Aug 26, 2015 9:59 PM
    left2rightdoor left2rightdoor Aug 27, 2015 1:00 AM Flag

    Whatever the reasons, it will be interesting. Presumably Sarepta will go second. Its competitor has recently been talking about targeted drug formulations - obviously they have realized the charge neutral nature of eteplirsen minimizes off-target effects, and so will be trying to present their drug as more "targeted" than previously understood. That is only one of the differential issues. Others are patient reported outcomes (PROs), key clinical endpoints to be emphasized, age stratification of efficacy, FDA staff analysis and reports, and of course safety/toxicity. One of the key things one FDA staff said at one or another symposium was they
    were not going to be over-supervisorial on risk benefit choices of patients with DMD. They have statisticians on the PNDAdCom but if you show dystrophin, numbers of patients, power, totality of data won't matter. If you make dystrophin, they will walk.

  • left2rightdoor by left2rightdoor Aug 26, 2015 2:02 PM Flag

    To determine and review the composition of the SNS Program assets, HHS and CDC consider many factors, such as current biological and/or chemical threats, the availability of medical materiel, and the ease of dissemination of pharmaceuticals. One of the most significant factors in determining SNS composition, however, is the medical vulnerability of the U.S. civilian population.

    The SNS Program ensures that the medical materiel stock is rotated and kept within potency shelf-life limits. This involves quarterly quality assurance/quality control checks (QA/QC's) on all 12-hour Push Packages, annual 100% inventory of all 12-hour Push Package items, and inspections of environmental conditions, security, and overall package maintenance.

  • Reply to

    PPMD

    by greyzone513 Aug 26, 2015 10:41 AM
    left2rightdoor left2rightdoor Aug 26, 2015 1:58 PM Flag

    PPMD is holding a Webinar on AdComs next week Wednesday Sep 2.
    FDA said to participate You wonder how much FDA can say, given highly contentious nature of these duelling proceedings. Probably trying to organize the base to get as much patient/family participation as possible

    Time: September 2, 2015 from 1pm to 2pm
    Location: Online Webinar - Eastern Time Zone
    Website (Link deleted on this message board to keep post up)
    Phone: 866.740.1260 -- Access code: 9449985
    Event Type: webinar
    Organized By: PPMD

  • left2rightdoor by left2rightdoor Aug 26, 2015 9:27 AM Flag

    Potential acquirers can soak up any short attacks by buying for own portfolio acquisition purposes PFE or, just to be totally ironic, GSK , others

  • left2rightdoor by left2rightdoor Aug 26, 2015 12:59 AM Flag

    Statement from MDA Scientific Program Officer Laura Hagerty, Ph.D.:

    “This is another important step forward for our Duchenne families. Now, two potential DMD treatments have had their NDAs accepted by the FDA for priority review and both companies will be hoping for a positive decision in early 2016. We’re nearing the finish line — this is as close as we’ve ever been to having approved therapies for one of the most common and debilitating forms of muscular dystrophy.

    “MDA has provided support for the development of exon skipping since the 1990s and we are proud to have funded foundational research that has made these new treatments possible. It is a sign of great progress to witness multiple companies working on different therapies to get urgently-needed treatments to our families.

    “MDA is committed to bringing safe and effective treatments and cures to children and adults living with life-threatening neuromuscular diseases as quickly as possible. Today, there are new treatments in the pipeline that were inconceivable just a few years ago and more potential treatments are expected during the next five years than in the past five decades. As these treatments enter the regulatory review phase, MDA continues to work hand-in-hand with families, health care professionals, scientists and the FDA to ensure it has the necessary information and support to efficiently make decisions on potential life-changing drugs and to move these treatments from the labs to our families’ living rooms.”

  • The voucher enables expedited review of exon skipping for 45, 53, etc, to cover maximum spectrum of exon-skipping amenable DMD boys (and girl) under a provision of FDASIA . the entire DMD community should be celebrating today.

  • will discuss what an advisory committee does, with FDA participation, pre-registration necessary.

  • The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is proposing to add certain influenza virus strains to the list of HHS select agents and toxins. Specifically, we are proposing to add the influenza viruses that contain the hemagglutinin (HA) from the Goose Guangdong/1/96 lineage (the influenza viruses that contain the hemagglutinin (HA) from the A/Gs/Gd/1/96 lineage), including wild-type viruses, as a non-Tier 1 select agent. We are also proposing to add any influenza viruses that contain the HA from the A/Gs/Gd/1/96 lineage that were made transmissible among mammals by respiratory droplets in a laboratory as a Tier 1 select agent. We have determined that these influenza viruses have the potential to pose a severe threat to public health and safety.

  • So fundamentals still producing $2.25 GAAP earnings, but Ex-CEO may have some issues. Co stilllooking at acquisitions (and awaiting Peanuts)

  • PMOplus is a Sarepta proprietary, adaptable platform chemistry that contains a selected number of positively charged linkages in the form of piperazine residues at specific locations along the PMO backbone. The PMOplus platform comes with advantages for antisense complexes, improving their stability (making them resistant to degradation, compared to conventional antisense methods), function, bioavailability, and binding kinetics.

    PMOplus is stable because it is a morpholino analog that has phosphorodiamidate linkages; this basic structure is resistant to degradation by RNA and DNA enzymes. In addition, the positive charge from the piperazine ring is believed to improve the binding of the PMOplus to the target messenger RNA, which may enhance activity against Ebola, according to Alison Heald, Clinical Assistant Professor at the University of Washington in Seattle and lead researcher of a follow-up phase 1 study evaluating AVI-7537 in 30 healthy men and women.10 “The PMOplus platform has enormous potential because the safety profile is attributed to the PMO chemistry, not the antisense sequence,” she says.

  • left2rightdoor by left2rightdoor Jul 30, 2015 7:18 AM Flag

    More traffic accidents among teenagers than the world has ever seen before. I was just in a car climbing a hill behind a fiat going 45 uphill on the freeway and when I went past looked over and a kid had his phone at the 12 position on his steering wheel and was trying to steer while texting

  • Trying to look at Panama Mexico penalty, and all I get from Yahoo is audio of an ad I can't even find on
    the page to shut off, and it turns out to be John Kasich running for President. Another guy I can forget
    based on Yahoo political advertising slowing down the internet.

  • Kaye talked about publication of natural history data for the DMD boys, to come before a fall
    advisory committee meeting. The publication of AVI Marburg Phase I data is merely a lagniappe.
    The main information package is yet to come.

  • Because YHOO - has bad (terrible) search suggestions; too many promoted results making it difficult to get to real search results; and slow scripts loading causing browser to stop or abort.

  • Reply to

    aha!!

    by pebble16x Jul 17, 2015 4:59 PM
    left2rightdoor left2rightdoor Jul 17, 2015 5:15 PM Flag

    But what is the Ex-AABACO date. Nov 30? Dec 5? Nov 15? When will they give the date to hold for the
    spinout. Someone should ask MM at the conf call on Qtrly earnings. Everything else pales in relation to the spinout ex-date.

  • left2rightdoor left2rightdoor Jul 17, 2015 3:01 PM Flag

    Change 2 letters with eteplirsen approval
    Going from SR to IC, ie ICPT like market cap.

  • In May and June, CDC guidance on H5N1 said that stockpiled antivirals including peramivir could be used in human cases of H5N1 infections (probably in view of multi- state widespread poultry outbreaks) and in the guidance for clinicians updated as of June 11 include peramivir as among the recommended antivirals.

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