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Trius Therapeutics, Inc. (TSRX) Message Board

bionerd51 34 posts  |  Last Activity: Apr 15, 2015 11:40 PM Member since: Jan 2, 2007
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  • Reply to

    exclude from evidence

    by ru.empeirikos Apr 15, 2015 4:23 PM
    bionerd51 bionerd51 Apr 15, 2015 11:40 PM Flag

    The backbone, linkage, the charge, the pharmacodynamics/kinetics are all different. The clinical differences are even more profound. In the IM study the PMO outperformed the 2'OME. The canine study the PMO blew away the 2'OME [Drisa]. In the human clinical trial, according to RNA, eteplirsen produced 10 X's more dystrophin then Drisa. Eteplirsen meets the definition opt a novel drug compared to Drisa. I think I hear the fat lady singing.

    Sentiment: Strong Buy

  • bionerd51 by bionerd51 Apr 15, 2015 6:57 AM Flag

    The discrediting of RNA's expert witness is of secondary importance in this case. The reason behind it relates to the "novel" differences of the 2 oligos in question. RNA's position is that the oligos are similar via mechanism of actions and clinical results. If the court sides with UWA's motion to discredit this expert witness it discredits RNA's position that the 2 oligos are not novel. Any expert in the field of exon-skipping and oligonucleotides, including synthetics, can only conclude that the PMO is not only an improvement in design over the 2'OME but there exists CLINICAL proof the PMO is superior to the 2'OME. This is a dagger in the heart of RNA's case.

    Sentiment: Strong Buy

  • bionerd51 bionerd51 Apr 10, 2015 10:43 PM Flag

    Starfe, I hate to say this about you because I like you, you are delirious. The BOD has done everything to protect the company from being bought out. From where they are incorporated, to the scientific team they have assembled, to passing on several buyout attempts, like Shire, Biomarin and Genzyme. The BOD will resist all attempts of a buyout. SRPT is not being bought out. They are building the next biotech giant. They will be the next orphan drug giant. DMD, all exons, Myotonic dystrophies, Pompe disease and antibacterials will propel Sarepta into the biotech stratosphere. Your decision should be clear. Do I hitch my wagon to a drug that failed a large Phase III trial [Drisa] or do I use my cerebellum to critically analyze 3 year data that conclusively proves that eteplirsen is a once in a life time drug that saves boys that suffer from Duchennes, an insidious fatal disease, from death.

    Sentiment: Strong Buy

  • Reply to

    Lots

    by thigrlsrk Apr 8, 2015 7:50 PM
    bionerd51 bionerd51 Apr 9, 2015 6:46 AM Flag

    Starfe, BMRN's Drisa's success or failure has nothing to do with SRPT's eteplirsen's NDA application and eventual approval. This is spin spun by WallStreet types who advance this rhetoric because their overall lack of knowledge of the differences between the 2 oligo's, which are significant, prevents them from intellectually and conceptualizing the complex dynamics and kinetics of both oligos. The FDA can't approve BMRN's AA for 2 obvious reasons. First, their data demonstrates absence of efficacy and more importantly at the AA level, structural damage of the renal tubules. The only position the FDA will take is for them to recommend BMRN run another P-3 trial to prove their hypothesis that a subgroup benefitted from Drisa and that those benefits outweigh the harm this drug causes.

    Sentiment: Strong Buy

  • Reply to

    In your wildest dreams

    by starfe11 Apr 8, 2015 9:48 AM
    bionerd51 bionerd51 Apr 8, 2015 9:59 AM Flag

    Starfe, CG is gone. Give it up. What good does it do to continue to bash him when he's been gone for a week??

    Sentiment: Strong Buy

  • Reply to

    Call buying

    by blankwillie Apr 7, 2015 12:41 PM
    bionerd51 bionerd51 Apr 8, 2015 7:24 AM Flag

    They can be but flash frozen proteins result in a weaker signal for quantification.

  • Reply to

    a brief millisecond of common sense

    by simp08801 Apr 7, 2015 6:59 AM
    bionerd51 bionerd51 Apr 7, 2015 7:14 PM Flag

    JRRT1, Just to add to your post regarding fresh vs. frozen samples…Fresh, non frozen samples are the best, when visualizing proteins compared to frozen. Frozen proteins denature or change shape. Preparation for deep freeze one must sterile [filter] protein, separate into very small specimens, add a bacterial static chemical and then add stabling agents like glycerol and then reducing agents. Anyone with out an advance degree in lab procedures can understand that fresh, unfrozen protein examination is best.

  • Reply to

    a brief millisecond of common sense

    by simp08801 Apr 7, 2015 6:59 AM
    bionerd51 bionerd51 Apr 7, 2015 1:37 PM Flag

    Simp, Your comment, "I do not think the 4th biopsy results are anywhere near done" deserves a question. Most of the biopsies were taken over 30 days ago. Do you believe they are sitting on a shelf somewhere waiting for FDA direction??

    Sentiment: Strong Buy

  • bionerd51 bionerd51 Apr 6, 2015 12:28 PM Flag

    Hanson too. Great chemistry and drug discovery backgrounds. CG did put together a great drug discovery/research team. Both would make great CSO's.

  • bionerd51 bionerd51 Apr 6, 2015 12:22 PM Flag

    Wenworth. Came over from Genzyme. Top notch and has done extensive oligo [PMO/PPM} research into Pompe disease and Myotonic Dystrophy. It is no coincidence that those 2 areas are on SRPT's clinical radar.

  • bionerd51 bionerd51 Apr 6, 2015 8:58 AM Flag

    Conrad, Unfortunately neither one is still will the company.

    Sentiment: Strong Buy

  • Reply to

    Message to Chris G.

    by truth_told Apr 1, 2015 9:17 PM
    bionerd51 bionerd51 Apr 4, 2015 10:18 AM Flag

    Tred, Never with the detail of the recent article. FDA blames CG for the bad press in general. When have you ever seen the FDA release a public statement to correct comments made by a biotech CEO regarding their [FDA] handling of a regulatory matter? I have absolutely no love lost for the FDA and I have been a critic for decades but it became personal between CG and certain members at the FDA. The BOD acted.

  • Reply to

    Dris is going to get approved

    by starfe11 Apr 2, 2015 5:31 PM
    bionerd51 bionerd51 Apr 3, 2015 6:54 AM Flag

    Starfe, You keep posting that "Drisa is going to be approved". No more shouting. Make YOUR case on why Drisa should receive a positive nod at the FDA. No rhetoric, please.

    Sentiment: Strong Buy

  • Reply to

    Message to Chris G.

    by truth_told Apr 1, 2015 9:17 PM
    bionerd51 bionerd51 Apr 2, 2015 10:52 AM Flag

    Tred, The FDA was blaming CG for planting the conflict-of-interest story regarding Hoffman and the FDA.Personally I see nothing wrong with what CG did but the Board of Directors did. They also believed with CG in charge that eteplirsen would no longer receive a fair hearing at the FDA for AA. They acted.

    Sentiment: Strong Buy

  • Reply to

    If

    by thigrlsrk Mar 30, 2015 8:07 AM
    bionerd51 bionerd51 Apr 2, 2015 7:33 AM Flag

    Your correct in your comments. Biopsies are surgical procedures that are not performed without clear endpoint parameters. To imply these samples are in cold storage for months while the FDA makes up its mind is beyond ludicrous. Once the sample is excised the cells and tissues die rapidly. Dystrophin is a highly structured [Quaternary] delicate protein out of a living system. Degradation comes quickly and the sole purpose for this procedure is to count functionally positioned dystrophin [IHC].

    Sentiment: Strong Buy

  • Reply to

    If

    by thigrlsrk Mar 30, 2015 8:07 AM
    bionerd51 bionerd51 Apr 1, 2015 7:11 PM Flag

    The FDA has already given guidance on quantification methods. Where have you been. The IMF [IHC] and Western Blot. The only issue the FDA is weighing right now is what weight to give these findings. This was a major topic covered in workshop.

  • bionerd51 by bionerd51 Apr 1, 2015 5:19 AM Flag

    This quote says it all…: "Management Transition Aimed at Normalizing Relations with the FDA"

    Sentiment: Strong Buy

  • bionerd51 by bionerd51 Mar 31, 2015 9:18 PM Flag

    Board realized that CG was no longer an asset and was actually a hindrance in their efforts for eteplirsen approval. He's an example of a CEO pushing too hard at exactly the wrong times. FDA and his own researchers despised him.

  • Reply to

    A little more from Dirk.......

    by georgecantstansya Mar 27, 2015 8:28 AM
    bionerd51 bionerd51 Mar 27, 2015 10:48 AM Flag

    George, Dirk suffers from "target fixation". He focuses on a chemistry [in this case S-DNA's] so subjectively that he see's nothing else and flies right into it.

  • Reply to

    A little more from Dirk.......

    by georgecantstansya Mar 27, 2015 8:28 AM
    bionerd51 bionerd51 Mar 27, 2015 8:42 AM Flag

    George, Keep in mind that Dirk advocated for S-DNA's dating back to Genasense and discredited PMO's solely based on cell culture studies. I have been presenting clinical data to him for 17 years on the superior multicellular, intracellular delivery of PMO's. For 17 years I also have been warning S-DNA advocates of the renal and hepatic toxicity toxicity inherent in this oligo. He finally gets. I guess it's never too late.

    Sentiment: Strong Buy

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