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Vical Incorporated Message Board

left2rightdoor 51 posts  |  Last Activity: 13 hours ago Member since: Jul 16, 2012
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  • left2rightdoor by left2rightdoor 13 hours ago Flag

    Of son blowing out candles with hashtag etepworks

  • left2rightdoor by left2rightdoor Oct 5, 2015 10:09 PM Flag

    Contract Award Number:
    Contract Award Dollar Amount:
    Contractor Awarded Name:
    BioProtection Systems Corporation
    Contractor Awarded DUNS:
    Contractor Awarded Address:
    2503 South Loop Drive, Suite 5100

    Ames, Iowa 50010
    United States
    Added: Sep 30, 2015 1:23 pm

  • Reply to

    Darn, mentioned on Nightly Business Report

    by left2rightdoor Oct 2, 2015 10:50 PM
    left2rightdoor left2rightdoor Oct 5, 2015 4:08 PM Flag

    CHI PFO ETG and a little GGN just to have gold as a backstop ALSO Qtly T, VZ,

  • left2rightdoor by left2rightdoor Oct 3, 2015 6:09 PM Flag

    Remember the fireside chat - Dr. k said a peer reviewed article was coming before AdCom - on natural history v. Etep?

  • Reply to

    FDA Insights

    by variant_perception Oct 2, 2015 6:06 PM
    left2rightdoor left2rightdoor Oct 3, 2015 12:30 AM Flag

    It is not clear that anyone said we aren't going to accept dystrophin as a biomarker. They may have said we aren't sure about the measurement of dystrophin (request for independent reviews). But if they weren't thinking of dystrophin as a biomarker, they wouldn't have asked for the fourth biopsy, which I thought Dr. Kaye said they had requested. You only ask patients to undergo multiple biopsies if the results are significant, perhaps critical, in decision making. In this case, dystrophin production, verified by agreed upon protocols and independent review, corroborates the clinical benefit of +151 6Mwt. Together, those two things complement each other.

  • now others going to drive price up and yield down.

  • DMD valuations do not even consider the PMO platform value for Influenza, Marburg, Ebola (or now MS
    with new academic partnership) Possibility of ICPT like valuation when pipeline fully developed.
    AVI-6002 for the treatment of Ebola is a combination therapy of two phosphorodiamidate morpholino oligomers (PMOs AVI-7537 and AVI-7539), which target the viral matrix proteins VP24 and VP35, respectively. AVI-6003 for the treatment of Marburg is a combination therapy of two PMOs, (AVI-7287 and AVI-7288), which target the viral proteins VP24 and NP, respectively. These drug candidates use Sarepta's advanced and proprietary PMOplus® chemistry, which is also the basis of the company's clinical-stage influenza drug candidate, AVI-7100

  • Univ of West Australia UWA(Steve Wilton) Sarepta's inventor licensee
    filed interference against Prosensa's inventor Deutekom/UCL
    UWA claimed interference and priority (earliest date of invention)
    Because UCL patent was 1)overly broad, claimed all possible antisense oligonucleotides (ASO's)
    of which there are billions of possible molecular combinations, having different effects
    2) UCL claim was unpatentable because ASO's filing did not describe to reasonable
    person how to construct such an broad invention, having only described 1 (one) ASO.
    when it would take millions of experiments to find the right ASO for Exon 51 (or others)
    The decisions says, to establish priority, you must be entitled to judgement, and
    the one ASO shown results in constructive reduction to practice, so UWA's
    claim of priority based on unpatentability fails, cause they have the one ASO.

    However, this does not establish that the breadth of the claim is valid, this was merely a rejection of UWA's claim of priority based on unpatentability. The other patent issues, breadth, composition of matter,
    other exons, are all still in play. (and the patent decision also explains exon skipping and the role of dystrophin, so it is actually a good thing to show the FDA, here, a legal opinion says dystrophin, or the lack thereof, causes DMD.)

    So it all comes back to producing dystrophin about which we will hear tomorrow.

  • left2rightdoor left2rightdoor Sep 30, 2015 2:41 PM Flag

    We already know what you do if you're in Europe and your son has DMD, and you can't get eteplirsen there.
    You come to the US where it is, and will shortly be generally, available as a dystrophin producing therapy to convert DMD to Beckers. From Surrey, England paper:

    A five-year-old from Send has flown to America with his mother to take part in a clinical trial on a drug to treat muscular dystrophy.

    Leon Arnold was diagnosed with Duchenne muscular dystrophy, a fatal condition where the body’s muscles weaken and disability increases, last year.

    His family, including his two older brothers, have been working hard, raising awareness of the condition and money for Harrison’s Fund, a charity that is seeking a cure or ways to slow down the disease.

    The Send First School pupil is now in Iowa with his mother to take part in a clinical trial for eteplirsen.

    “Leon will start receiving weekly infusions following a three-week screening period, which included a muscle biopsy in Iowa and an MRI scan in Florida,” said his mother, Louise Crow-Arnold.

  • This is an exciting time to join Biocryst Statement from new board member

  • If the device is ultimately cleared or approved, the product labeling could include a description of the range of patient preferences and characteristics described by those data, providing patients and healthcare practitioners with key information to make well-informed decisions. It is important to reiterate that FDA would not approve a device if it determines the device would expose patients to an unreasonable or significant risk of illness or injury, or that the benefits do not outweigh the risks for a defined target population.

  • Christine McSherry talks about the lengths parents go to to find a therapy for their sons, and the worry that the delay has been too long. Has met with the agency (FDA) multiple times, but they have to go through their processes. If data from latest results are positive, pressure on FDA to move quickly will be intense. (and rightly so.)

  • Connolly got grant to study prednisone in young patients from MDA, Shieh identifies neurological deficiencies in young children Mendell runs clinical trials, and Mercurio (from Europe). Collaborates with Muntoni. and of course Steve Wilton is The Dystrophin Guy.

  • Someone asked when they would release it. They said an investor presentation, so it should be before
    market opens, cause Reg FD would not be satisfied if data presented at WMS selectively first. If data
    continues to show significant improvement and PRO better than Natural History, should be positive
    for AdCom and approval. Rise from supine, upper body, respiratory measures

    All patients, even those age 12-15, continue to demonstrate an ability to climb stairs, to rise from supine, and to raise a hand to the mouth at a rate higher than what was observed in a natural history study of glucocorticoid-naïve or steroid-treated boys with DMD (Henricson et al., 2013). All 12 patients, including the two non-ambulatory patients, demonstrated PFT stability from baseline through Week 168, including MIP (+11.1%, p=NS), MEP (+13.5%, p=NS), and MIP/MEP %-predicted (-2.4%/-6.3%, p=NS).

  • Reply to

    Horizon Organics showing Snoopy Peanuts game

    by left2rightdoor Sep 21, 2015 6:32 PM
    left2rightdoor left2rightdoor Sep 23, 2015 11:22 PM Flag

    I saw that too, Kathy Lee Gifford was Peanutized. kids will love doing that to themselves and all their friends

  • packing lunches for children, ad in Real Simple by Horizon organic snacks and milk, Peanuts movie tie-ins starting to appear in media.

  • So probably about a week away from Nov 23,24 notices.

  • left2rightdoor by left2rightdoor Sep 19, 2015 11:04 PM Flag

    To get eteplirsen in new Sarepta younger cohort clinical trial From Get Surrey, Boy travels to Iowa

    A five-year-old from Send has flown to America with his mother to take part in a clinical trial on a drug to treat muscular dystrophy.

    Leon Arnold was diagnosed with Duchenne muscular dystrophy, a fatal condition where the body’s muscles weaken and disability increases, last year.

  • A key recommendation of Science Forward subcommittee report to FDA Science Advisory Board for Sep 15 meeting. Mentions especially diseases with no treatment like Alzheimer's (or DMD) so using dystrophin biomarker would be touted by FDA as an example of how they are following this recommendation. See meeting today materials - this is another advisory committee but on general topic of how FDA can keep up with scientific advances

  • left2rightdoor by left2rightdoor Sep 15, 2015 8:43 AM Flag

    After Capitulation by shareholders

0.41Oct 12 4:00 PMEDT