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Inergy, L.P. Message Board

wilderguide 347 posts  |  Last Activity: 8 minutes ago Member since: Jan 13, 2011
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  • wilderguide wilderguide Mar 26, 2015 5:33 PM Flag

    $$$$
    I didn't mean to step on your optimistic post, but these scenarios most often play to an inside crowd till an appropriate venue avails, and the data has developed a sense of maturity. An encouraging word from Coric couldn't hurt, but any disclosure suggesting a clinically meaningful outcome for NSS is not yet warranted. It's simply too early on in the trial...

  • wilderguide wilderguide Mar 26, 2015 2:41 PM Flag

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    JMO, but the importance of preserving the integrity of first authorship is the usual precedent. I think in this case, trial results will likely be authored by the CSO of NVIV, and supplemental data will be provided by the attending neuros...with supplemental data provided by those actually conducting the implants. Authoring a study takes time, and it's in everyone's best interest to insure a viable abstract is presented. In addition, the importance of peer review cannot be overlooked - and this - of course - means more time. In an earlier post, I put up likely presentation venues. I look forward to the PR that ushers in the first abstract. It would be particularly historic if Doc Langer were invited to present the initial abstract of his own invention with the first human trial data.

  • wilderguide wilderguide Mar 26, 2015 12:25 PM Flag

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    Beyond perhaps a mention of a promising new implant procedure, I wouldn't expect much from Doc Coric. The NSS safety trial is not yet half enrolled, and professional clinical protocol requires presentation before discussion. Don't let MB frenzy blind you to the nature of clinical process. It's early, and it's all looking good... But there are acceptable standards of presentation to which adherence is SOP. Be patient.

  • wilderguide wilderguide Mar 26, 2015 12:33 AM Flag

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    The Keck-Rutgers collaboration promises to deliver the most advanced stem cell technical applications ever witnessed, and NVIV's timely exposure here could prove remarkably fruitful. The introduction of the Keck enrollment site is amongst the best news to date, and I encourage all to DD the overall extent of this working partnership. The best & brightest are being enlisted here, and it gives me the warm fuzzies to know the NSS is being studied by these combined elite stem cell research teams. GLTA

  • $$$$
    All these self-proclaimed TA wizards are lagging in reporting, but I like what I'm seeing...
    Offsite, Seymour, jonesdexter, nomad, milkman...break out yer magical charts so's I know what do...
    Absolutely lost without yer inputs here... Seymour, should I sell...?????

  • Reply to

    Down 12% in last 2 days.

    by abatulis Mar 23, 2015 12:44 PM
    wilderguide wilderguide Mar 23, 2015 1:52 PM Flag

    $$$$
    Window dressing and hedge fund portfolio rebalancing. EOQ coming soon - profits must be shown.
    This could create a really good buy scenario...JMO

  • Reply to

    FDA Approval

    by chatham914 Mar 22, 2015 8:30 PM
    wilderguide wilderguide Mar 23, 2015 9:03 AM Flag

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    OK, so you are a proponent for early approval based upon your obvious confirmation bias. I can work with that... Let's say I'm the FDA and you bring your data to me. I say fine, let's approve your scaffold based on what we know. You can implant your product in appropriately injured young, well-trained, highly disciplined, physically fit motorcycle riders under the age of 30. Do you really think this is the measure of commercial viability Perrin is seeking? Not to mention the data the insurers will want before they'll agree to pay for NSS... No, the device has to display a wider breadth of successful response to be a candidate for commercial success. Simply put...the FDA will need more objective data.

  • Reply to

    FDA Approval

    by chatham914 Mar 22, 2015 8:30 PM
    wilderguide wilderguide Mar 23, 2015 8:09 AM Flag

    $$$$
    Not to put too fine a point on it...
    The fact is this. Despite what appear to be dramatic responses from the first two enrollees, these youths hardly profile a cross section of the general population. If ever there were candidates for spontaneous recovery, these two would take all bets. To maintain clinical credibility, the data pool must contain a more realistic representation of potential NSS implant candidates.

  • Reply to

    curious

    by eddietees Mar 23, 2015 1:03 AM
    wilderguide wilderguide Mar 23, 2015 7:09 AM Flag

    $$$$
    "He should just go in his office and shut up..."
    A wise man follows his own advice. Get back in yer cubicle...take yer meds...
    Remember; sorassenib for no sorassatol. Neither one is a monoclonal antibody.

  • Reply to

    username, why will you be in trouble?

    by stocklooking Mar 20, 2015 4:41 PM
    wilderguide wilderguide Mar 22, 2015 11:52 PM Flag

    $$$$
    "There you go again."
    Yup. Take yer daily dose of sorassenib, grab yer ankles, and get ready for a big week. BTW - sorassenib is not a monoclonal antibody. That'd be sorassimab...not to be interchanged nor co-administered with sorbuttinib, sorebuttinol, or soresphinctoral.
    For your short condition, I'd prescribe sorassenib. Dose to a rash, then back off a full 10mg BID. No thanks necessary.

  • Reply to

    FDA Approval

    by chatham914 Mar 22, 2015 8:30 PM
    wilderguide wilderguide Mar 22, 2015 10:57 PM Flag

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    Early FDA approval based on what we know to date...?? Not likely. Consider this...
    Virtually every clinical trial has statistical "outliers" - participants that either outperform or underperform when compared to the median response group. Given that our first two enrollees are young, fit, motivated athletic types, all my instincts caution me to the possibility that these youngsters can easily be considered to constitute the optimum response group. Until the other end of the inclusion spectrum (advanced age, mobility constraints, less fit, relatively under-motivated) has been successfully explored, I'd recommend some rational prudence wrt over-zealous commentary regarding early approval and commercialization. The road to revenues will yet be long, though compelling early strides have been made. This research is still very early stage, however promising it does appear. GL

  • Reply to

    username, why will you be in trouble?

    by stocklooking Mar 20, 2015 4:41 PM
    wilderguide wilderguide Mar 22, 2015 3:49 PM Flag

    $$$$
    BTW - the -nib vs -MAB discussion probably tuned up a lot of folks on this MB as to what you actually know...vs what you pretend to know. You obviously dunno squat - no wonder it's all voodoo medicine to you. Aspirin is voodoo medicine to the likes of a poser like you.

  • Reply to

    username, why will you be in trouble?

    by stocklooking Mar 20, 2015 4:41 PM
    wilderguide wilderguide Mar 22, 2015 3:32 PM Flag

    $$$$
    "You're the biggest one..."
    Just remember this conversation the next time you collectively greet the MB as a pack of clueless bagholders. For my money, you can't get enough grief in return for your collective transgressions. It's easy enough to overlook the targeted personal strikes, but when you presume to be smarter than everyone you only make fair game of your own inadequate communications and peoples skills. Which - btw - you should really work on...JMO - but yer dummerin' a box o' rocks...

  • Reply to

    username, why will you be in trouble?

    by stocklooking Mar 20, 2015 4:41 PM
    wilderguide wilderguide Mar 22, 2015 12:22 PM Flag

    $$$$
    "People here claim all kinds of things...just leads to all the friction...keeps normal discussion impossible."
    Don't exclude yourself in this finger-pointing mission...

  • Reply to

    SonaCare News

    by loc.tone59 Mar 21, 2015 9:58 AM
    wilderguide wilderguide Mar 21, 2015 12:07 PM Flag

    $$$$
    From the a Sonacare PR dated 3/20...
    "CHARLOTTE, NC. Friday, March 20, 2015: Today SonaCare Medical announced that the Company has filed with the FDA a submission for a De Novo grant of its Sonablate® 500 HIFU system for the transrectal ablation of prostatic tissue. This submission is in addition to the Company's Pre-Market Approval ("PMA") application and study which it is continuing to pursue. The De Novo process was first introduced in 1997, with the implementation of the FDA's Modernization Act (FDAMA), as a means to reclassify novel medical devices of low to moderate risk profiles that were automatically deemed Class III because no substantially equivalent devices existed to merit a successful 510(k) submission."
    GLTA

  • Reply to

    Some thoughts on EXEL

    by rinostarr14 Mar 18, 2015 6:27 PM
    wilderguide wilderguide Mar 20, 2015 10:28 PM Flag

    $$$$
    Back when the Kidney Cancer Chronicles was an active site, Chris Battles' self-prescribed drug "holiday" from Cabo - and it's rebound effect on Chris's health - made me consider the possibility that a holiday from certain targets (as opposed to a complete treatment holiday) might have potential. I'd not yet been exposed to TKI switching, but - in hindsight - it makes a lot of sense. Thanks for the post, Bif...

  • $$$$
    Spinoff work on the A Ribas pubs. Posted 3/18/15 SCI Trans Med, Hu-Lieskoven, et al...
    Provides pre-clinical rationale for Roche wanting to stay on this combo...also describes why the combo of Vemurafenib plus ipilimumab may have gone bust in early work ups...very good read.
    "Our findings support the testing of triple combination therapy of BRAF and MEK inhibitors with immunotherapy in patients with BRAF(V600E) mutant metastatic melanoma."
    Have a good weekend!

  • Reply to

    clinical trial updates

    by socialidiocies Mar 20, 2015 1:08 PM
    wilderguide wilderguide Mar 20, 2015 5:49 PM Flag

    $$$$
    Nope. Look at the Matt Smith MGH dose-reduction study. It was a by-product of the RDT, and led to the Cabo dosing of the Comets...and all subsequent trials. The reference list here is very, very long. You should have no problems finding info once you put in the time. Lots and lots of time...this data pool is very old, very well researched, and has been peer-reviewed, published and cited for off-label prescription. Too much to amply cover on YMB. Yer on yer own here... GL

  • Reply to

    clinical trial updates

    by socialidiocies Mar 20, 2015 1:08 PM
    wilderguide wilderguide Mar 20, 2015 5:26 PM Flag

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    Just a brief note here on your research, guys...
    Look at the start date. The trial you are studying is the original P2 RDT signal-searching study that produced the initial striking BSR results and prioritized Cabo research. It's been hashed and rehashed endlessly here on this MB... and the expansion cohort of mCRPC patients has generated considerable write-ups in the JCO, the BJC, the EJC, and thru-out the life sciences and oncological communities. PMC carries an endless supply of references to this study. The Comet trial designs were predicated on the results of the mCRPC expansion cohort, Meteor was the result of the RCC cohort, and Celestial trial design was the result of the HCC cohort. Yer spinning your wheels here... That trial has lots of published results, including the promising 10 months mCRPC MOS data reported by Doc Scher, the promising pain data reported by Dan George, and the bone turnover studies in place at Dana-Farber. Not much new here...

  • wilderguide wilderguide Mar 20, 2015 1:01 PM Flag

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    "Seems like the scaffold has already proven itself..."
    You need to be a bit more objective. Two implants don't constitute a trial, though the FDA may allow further expedition of trial process. Peer review is also a requirement, and these results are not yet published. Patience...