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Genomic Health Inc. Message Board

mdwhittier 100 posts  |  Last Activity: 12 minutes ago Member since: Sep 17, 2012
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  • mdwhittier mdwhittier 12 minutes ago Flag

    Guessing it was a team effort, but shows the extensiveness of the platform's potential applications. I just kept wading through the chemistry until I got to some meat and potato's text; it's impressive.

    Sentiment: Strong Buy

  • mdwhittier mdwhittier 2 hours 24 minutes ago Flag

    None of the above patent information will impress the algo traders, T/A specialists, and those with a short-term time horizon. The framework for broad application of SRPT's PPMO platform is in place. SRPT has the potential of being the next CEGE or REGN, within 3 years.

    Sentiment: Strong Buy

  • As per Tweet from Bionerd51

    SRPT Patent updated 6-Nov-14

    FUNCTIONALLY-MODIFIED OLIGONUCLEOTIDES AND SUBUNITS THEREOF:
    http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=5&f=G&l=50&co1=AND&d=PG01&s1=%22morpholino+oligonucleotide%22&OS=%22morpholino+oligonucleotide%22&RS=%22morpholino+oligonucleotide%22

    In this document (and it's huge), scroll WAY, WAY, WAY down to:
    [0745] F. Antisense Activity of the Oligomers

    Additionally, there's the potential application of the platform for compounds that could eliminate the use of antibiotics in livestock/poultry feed, if the cost was equivalent or less:

    [0730] In another application of the method, the subject is a livestock animal, e.g., a chicken, turkey, pig, cow or goat, etc, and the treatment is either prophylactic or therapeutic. The invention also includes a livestock and poultry food composition containing a food grain supplemented with a subtherapeutic amount of an antiviral antisense compound of the type described above. Also contemplated is, in a method of feeding livestock and poultry with a food grain supplemented with subtherapeutic levels of an antiviral, an improvement in which the food grain is supplemented with a subtherapeutic amount of an antiviral oligonucleotide composition as described above.

    Sentiment: Strong Buy

  • mdwhittier mdwhittier 8 hours ago Flag

    I have to disagree on them needing a partner. Revenue from PDP will fund ongoing/future clinical trials. With BTD, this will sail through to AdCom and be a slam-dunk for FDA approval.

    Sentiment: Strong Buy

  • mdwhittier mdwhittier Nov 16, 2014 7:49 PM Flag

    Mattz: First of all, I don't believe that you are "in this field". Your grammatical errors suggest otherwise.

    Sentiment: Buy

  • mdwhittier mdwhittier Nov 14, 2014 4:08 PM Flag

    Yeah, you love it when folks put you on ignore, so you can dupe folks who are attempting some DD via BB's. You can't fool the core long crowd here, and some of us won't ignore you, b/c your posts are nefarious.

    Sentiment: Strong Buy

  • mdwhittier mdwhittier Nov 14, 2014 3:57 PM Flag

    You affect of sounding like a shrill, old-and-grumpy, scolding-grandma-type is a new twist from the short camp. I'd put you on ignore, but when you invoke knowledge of a fictitious "Timmy" who "felt better on Etep. and then felt worse", you crossed the line of tolerance for shameless shorts. Most likely you nothing more than a cross-dressing jonzkelly, who's looking for a new angle - right?

    Sentiment: Strong Buy

  • Manipulative.... False.... Statements = fooling no one

    Sentiment: Strong Buy

  • Reply to

    Why So Many Bashers????

    by greyzone513 Nov 14, 2014 10:05 AM
    mdwhittier mdwhittier Nov 14, 2014 1:17 PM Flag

    They are trying to extend the runway needed for the shorts to slowly cover. Better to cover now, and over the next few months, when dosing of new cohorts is fully underway. As no new safety issues are reported in a wider patient population, the stock price will lift. $15 is floor and the climb up from here could happen slowly, or quickly, based on anti-viral or anti-bacterial material news. The shorts know their run is over, hence the full court press, so tapered covering can begin.

    Sentiment: Strong Buy

  • mdwhittier mdwhittier Nov 12, 2014 1:59 PM Flag

    Look, SRPT won't issue a press (nor should they) when dosing begins for every boy in a new cohort. What's important is that these trials are enrolling and infusions beginning.

    Sentiment: Strong Buy

  • mdwhittier mdwhittier Nov 12, 2014 1:54 PM Flag

    COMPLETE FABRICATION...... SICK LIES.......MISINFORMATION......SHORT MANIPULATION....

    Sentiment: Strong Buy

  • mdwhittier mdwhittier Nov 8, 2014 1:12 PM Flag

    There is no political consequence for FDA's intransigence in not applying FDASIA. While the DMD community is bird-dogging FDA to pressure them to apply this law, the reality is that the DMD community, while strong and vocal; using social media to call out the FDA's foot-dragging, does not have the political clout that insurance lobbyists employ. While FDA appears to be insulated from political influences, that would be a false assumption. FDA speaks of openness and willingness to work with sponsors to move important drugs through their process, but in the case of Etep., it's all a smokescreen.

    Sentiment: Strong Buy

  • mdwhittier mdwhittier Nov 8, 2014 12:23 PM Flag

    It's not big pharma, but insurance lobbyists. The annual cost of Etep. will be tremendous, perhaps over $250k+ and treatment will last for years. Insurance co's have a lot of clout and their lobby with Congress is enormous. It's political pressure that FDA faces, which is putting the brakes on faster approval process for Etep. Otherwise, a rolling NDA would already be in play. Who is FDA protecting here? Protecting DMD kids from possibly receiving a drug that has a ?'s about efficacy?No, it's the insurance companies who are being sheltered from paying for a drug that has not been thoroughly vetted through scientific scrutiny.

  • mdwhittier mdwhittier Nov 8, 2014 12:08 PM Flag

    You don't get this at all, veee4. Sovaldi is essentially an expensive cure for Hep-C. But that cost pales in comparison with the larger and ongoing cost of hep-c health care, including possible liver transplants for untreated patients. Etep. on the other hand would cost much more annually than Sovaldi, and would be administered for years. Every heard of insurance lobbyists? The FDA is more worried about them, and their ties to Congress, than they are about advocacy groups. The FDA will never talk about this, but it's reality.

    Sentiment: Strong Buy

  • mdwhittier mdwhittier Nov 6, 2014 11:08 PM Flag

    The FDA is being pressured by large insurance companies to drag this out and leave no stone unturned in SRPT's quest for approval. This political pressure is greater than the DMD community, b/c insurance co's have powerful lobbyists working for them. Key folks at FDA are more interested in covering their butts, and they are hiding behind quantification methods of dystrophin to hedge and buy more time for the insurance industry.

    Sentiment: Strong Buy

  • As per FDA's website:
    "PEF is the maximum expiratory flow achieved during an expiration delivered with maximal force starting without hesitation from the level of maximal lung inflation (Quanjer et al., 1997). Specifically, in the absence of bronchial obstruction, PEF reflects expiratory muscle force (Suarez et al., 2002). While combined inspiratory and expiratory muscle weakness contributes to reduced lung and chest wall compliance (Smith et al., 1987), expiratory muscle involvement is a more prominent finding in patients with neuromuscular diseases.
    DMD patients exhibit reduced PEF in comparison to age-matched healthy individuals and a decline in PEF represents an early indication of the progression of muscular impairment. In conclusion, PEF is emerging as a valuable pulmonary outcome measure and clinical endpoint that is reasonably likely to predict an effect on irreversible morbidity or mortality during disease progression in DMD patients. PEF should therefore be regarded at a minimum as an intermediate clinical endpoint rather than as an exploratory endpoint."

    At least FDA is addressing PEF and considering it as an "intermediate clinical endpoint". However, if your child has already lost ambulation, and is heading in the direction of needing a respirator, one would think that PEF would be a critical endpoint, as it relates to overall survival. FDA is not protecting children, at this point, from a drug that potentially may be unsafe. It is protecting insurance companies from paying for a drug that may not have robust clinical efficacy across the DMD spectrum.

    Throwing up the various roadblocks for SRPT, in their quest to move this drug towards approval, is nothing more than #$%$ covering by FDA. They are only interested in protecting their jobs, and to avoid political pressure brought to bear by insurance lobbyists. FDA is pretending to partner with SRPT, but it's all for show, to appease parent support groups, who can see right through FDA's smokescreen.

    Sentiment: Strong Buy

  • mdwhittier mdwhittier Nov 4, 2014 4:47 PM Flag

    Meant to say: "As children's BMI increases (different from child to child), the load and muscle requirements in the legs of DMD boys INCREASES, eventually resulting in the loss of ambulation."

    Sentiment: Strong Buy

  • Reply to

    Dead money for 9-months+

    by system_architect_enterprise Nov 4, 2014 10:34 AM
    mdwhittier mdwhittier Nov 4, 2014 12:46 PM Flag

    Don't be so sure. As the various clinical trials unfold, and safety is observed (long before read-outs for efficacy data), this will shore up the stock price.

    Sentiment: Strong Buy

  • mdwhittier mdwhittier Nov 4, 2014 12:29 PM Flag

    At what point does the 6-mwt become less relevant, and pulmonary data become more important, particularly with older DMD boys who have already lost ambulation? As children's body mass index increases (different from child to child), the load and muscle requirements in the legs of DMD boys declines, eventually resulting in the loss of ambulation. It seems apparent that the earlier Etep. is initiated in younger boys, the slower the decline in walking ability.

    However, if the "mutant" dystrophin is inadequate to maintain ambulation over the long term, but it is sufficient to enable boys who have lost ambulation to engage in self-care behaviors (feeding themselves), and avoid the need for respirators, then the drug has unquestionable efficacy. Eventually, I think the 6-mwt endpoint may need to be re-evaluated as the most important clinical end point, if positive pulmonary data remains stable, and longer term self-care ability is enhanced.

    When the P3 confirmatory data is evaluated in its entirety, efficacy outside of the 6-mwt should also have a bearing on eventual approval of Etep.

    Sentiment: Strong Buy

  • From the Journal article: "Conclusions: ... our data indicate that the combined use of quantitative immunohistochemistry and Western blotting are reliable biochemical outcome measures for Duchenne muscular dystrophy clinical trials, and that standardized protocols can be comparable between competent laboratories. The methodology validated in our study will facilitate the development of experimental therapies focused on dystrophin production and their regulatory approval."

    The key here is this: "...standardized protocols can be comparable between competent laboratories."
    Is the FDA concerned that standardized protocols weren't being evidenced at Nationwide Children's Hospital? And, it appears that FDA wants intra-laboratory reliability between Nationwide Children's Hospital and Flagship Biosciences, which SRPT is using to evaluate future muscle biopsies, assuming that "mutant dystrophin" in sufficient quantities can be adequately measured.

    FDA wants scientific validation that the exon-51 skipping science, and SRPT's drug Eteplirsen, is actually creating increased dystrophin from baseline measurement. And, it wants validation of that with independent lab analysis.

    If the FDA is going to approve a drug that's going to cost insurance companies hundreds of thousands of dollars a year per child, it wants to have unquestioned scientific validity of the drug's efficacy. That's the political pressure that's being brought to FDA by insurance companies.

    And so we wait for additional biopsies in the confirmatory Ph3 trials. This isn't so much about safety, although that's important, it's about validating the drug's chemistry with irrefutable evidence of increased dystrophin production, confirmed by independent labs.

    Sentiment: Strong Buy

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