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Inergy, L.P. Message Board

wilderguide 371 posts  |  Last Activity: 11 hours ago Member since: Jan 13, 2011
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  • Reply to

    Shorts is done...

    by lagatik May 30, 2014 7:36 AM
    wilderguide wilderguide May 30, 2014 11:52 AM Flag

    $$$$
    "Any thoughts on the likelihood of a June 2014 completion..."
    Can't happen. Data lock will occur 12 weeks after recruitment of the final enrollee, and there are no provisions for any interim analysis. If any results can be spun earlier than that, those results will not be due to trial design. An early unblinding might be a consideration if stellar results come out of Comet-1...but I think at this point that's very wishful thinking.
    And ... yes, I would presume that the trial is not fully recruited based on recruiting status.

  • Reply to

    Shorts is done...

    by lagatik May 30, 2014 7:36 AM
    wilderguide wilderguide May 30, 2014 10:26 AM Flag

    $$$$
    Comet-2's snail-like recruiting pace is confounding, and I suspect that it's slow enrollment must be a result of mCRPC patients having some good go-to choices for approved therapy before they are compelled to explore the clinical trial process. Increased recruiting endeavors may speed the enrollment process, but - quite honestly - I think Comet-2 is a done deal. Overall survival is the big bat Cabo must swing, and the addition of pain to the prescribing label would not only be icing on the cake...but also a clear-cut differentiating factor that will push Cabo's commercial success. Sorry for your condition, Lag...just my attempt at humor. GL

  • Reply to

    Shorts is done...

    by lagatik May 30, 2014 7:36 AM
    wilderguide wilderguide May 30, 2014 9:02 AM Flag

    $$$$
    I'd like to help, Lag, but I don't see what you see...
    The last update to Comet-2 was 5/22, and it's not difficult to interpret.
    Are you on drugs? It's not fair to not share...

  • wilderguide wilderguide May 29, 2014 8:20 PM Flag

    $$$$
    Hi Chiraag,
    I've actually held HALO since 2010, though I admittedly halved out in the 13's...too soon.
    Considering adding with my tax refund...

  • wilderguide wilderguide May 29, 2014 5:06 AM Flag

    $$$$
    "Several newer approaches, including siRNA targeting of mutated KRas and enzymatic depletion of hyaluronan with PEGylated hyaluronidase are particularly exciting given their early stage results."

  • $$$$
    Europe Pubmed Central June 2014, Drs Samore & Gondi...expert opinion.
    GLTA

  • $$$$
    Europe Pubmed Central June 2014, Drs Samore & Gondi...
    More juice for the European campaign. Very little has been as yet published on Cabo in PDAC, with exception that cabozantinib has shown to overcome treatment-induced resistance to gemcitabine (Gemzar).
    GLTA

  • Reply to

    PFE -AZN dal goes bust

    by wilderguide May 27, 2014 2:40 PM
    wilderguide wilderguide May 27, 2014 3:37 PM Flag

    $$$$
    I actually do appreciate the support everyone has shown. I originally thought to post the story only because it struck me as comical that a grown man would so repeatedly and predictably commit a social crime that I could slowly contrive to catch him on camera. The stupidity of some people is just amazing...it's surprising some can think to breathe. GL

  • Reply to

    PFE -AZN dal goes bust

    by wilderguide May 27, 2014 2:40 PM
    wilderguide wilderguide May 27, 2014 3:14 PM Flag

    $$$$
    "Did you go to the police?"
    It's all in due process as of today. The Bozo's boss has declined to comment, and will not meet with me. He has sent along a voicemail that he will respond in writing. That will change. I'm patient, I'm in the right, and I have proof. An application for a permanent restraining order is being filed this week. If you like, I'll keep you posted. Actually surprised you'd be interested.

  • Reply to

    PFE -AZN dal goes bust

    by wilderguide May 27, 2014 2:40 PM
    wilderguide wilderguide May 27, 2014 2:42 PM Flag

    Deal, of course...

  • wilderguide by wilderguide May 27, 2014 2:40 PM Flag

    $$$$
    "In choosing to reject Pfizer, AstraZeneca is leaving a 30% premium on the table from where AZN is currently trading. In the attached clip Raymond James’ Jeff Saut says AstraZeneca’s rejection is a sign of the times in a deal crazy year.

    “Unless my pencil is broken I think we have more M&A activity this year than we’ve seen in decades,” says Saut. “I think that’s very positive for corporate America. I also think it’s a sign that cap ex is going to pick up here in the not-to-distant future."
    I'm thinking EXEL might look pretty darned attractive with 2 approved drugs in 4 indications by the end of 2015. Whoever is sitting on this SP is doing a pretty fair job, but I believe we are on the verge of a news cycle whose positivity may propel this bad boy much like we saw in the wake of the initial BSR reporting.
    GLTA

  • Reply to

    search twitter with 'cabozantinib'

    by marinolman11 May 26, 2014 3:49 PM
    wilderguide wilderguide May 27, 2014 12:28 AM Flag

    $$$$
    mRCC is a tough nut to crack, and there is a lot of literature to suggest that PFS is a reliable surrogate endpoint for OS, and has been accepted as such by the FDA in past approvals in this indication. Sunitinib approval was based upon extended PFS...and Cabo has already shown to provide benefit in Sutent-refractory patients. I think Cabo has a very good chance of approval in the kidney space...
    GLTA

  • Reply to

    OT: Bait and Switch revenge

    by wilderguide May 25, 2014 12:27 PM
    wilderguide wilderguide May 26, 2014 11:32 AM Flag

    $$$$
    Thanks all for the many suggestions...
    Here's what I think we are going to do, and the order in which we will initiate the undoing:
    1. Talk to his boss on Tuesday. This way we'll get a feel for the overall importance of whatever role this Bozo plays within the organization. If I were this guy's boss, it would take some seriously irreplaceable job skills to convince me to carry such a potential liability without some clearly defined - perhaps even contractual - reassurances of behavior modification. I might even suggest a therapist. If his boss wants to keep Bozo on the payroll, he'll pay top dollar for the evidence, and do all he can to preclude repetition, as well as retribution. At any rate, it'll be interesting to watch Bozo squirm because from there we...
    2. Talk to the district attorney's office to fully understand our rights and filing options, including the timeline for filing charges. Longer would be better. My initial research has revealed that there are many levels of trespass, from minor infractions to aggravated misdemeanors to felony classification with mandatory jail time. Given the repetitive nature of these incidents, the multiple log-ins with the sheriff's dept, and the irrefutability of the evidence...I suspect the court will mandate a somewhat lengthy probation, in addition to restitution.
    3. Show Bozo the goods, and let him make an offer to buy the evidence. This will prove the most difficult, but should give us an idea of how importantly he values his job, his DL...even his ability to be in charge of his own destiny, rather than become a ward of the court. He might actually cough up some serious dough to keep this whole thing out of court.
    4. Put up a large sign: "No Trespassing under Penalty of Law: Security cameras enabled courtesy of Bozo's Boss (the actual company name)". All his friends (and his parents) would surely ask him, "Isn't that the outfit you used to work for...??"

  • Reply to

    OT: Bait and Switch revenge

    by wilderguide May 25, 2014 12:27 PM
    wilderguide wilderguide May 25, 2014 4:49 PM Flag

    $$$$
    Actually, I think the last thing I want to do at this point is tip my hand to him.
    I have every intention of talking to his boss, and also to the District Atty's office, but - at least for now - I'm not going to let on that I have the goods on him. I'm actually hoping that he tries to lie to his boss wrt company vehicle misuse, in which case I may share the evidence with his company. If he's a valued employee (I really have no idea), I may consider selling the evidence to his company at a substantial markup. I can be bought, but I'd like to let on that further evidence is pending legal interpretation. I don't want to show my hand too early.

  • Reply to

    OT: Bait and Switch revenge

    by wilderguide May 25, 2014 12:27 PM
    wilderguide wilderguide May 25, 2014 1:59 PM Flag

    $$$$
    "Just my perspective, from having interactions with oddball neighbors..."
    I appreciate the inputs from everyone, and agree it IS problematic to file charges against a neighbor, but we have a case for a permanent restraining order in the works, as there have been earlier reported infractions of lesser nature, though of persistent intent. Minor squabbles over irrigation, fencing, and livestock grazing have all come into play, and in the recent past - during a temporary absence - he locked up a few of our pasture animals in a pasture pen without available water. That was "all-she-wrote" for me...I won't tolerate intentional animal abuse, especially directed toward my favored mare.
    #$%$ community, poorly-bred (possibly even in-bred?) constituency, backwards education system...all coupled with an understaffed and underfunded sheriff's dept. A hard-times community on the economic decline. Crime on the rise, gun ownership also on the rise. I have my share...and firmly believe so should we all. Like the song says, "What's a poor boy to do?"

  • wilderguide by wilderguide May 25, 2014 12:27 PM Flag

    $$$$
    An amusing short story for all. My wife has had a recent issue with a neighbor that has chosen to display his distaste for her choice of a flower bed location by driving through it on a daily basis. This has persisted for a couple of weeks, despite some sharing of words and a series of reports to the local sheriff's dept. This holiday weekend I decided to take a different view of the situation to bring about an immediate resolution. What I got was much, much better than I could have hoped for...
    My wife is an assistant campaign manager for a campaigning county official, and we decided to forego the flowers for some roadside holiday campaign signage - replete with US flags and campaign ribbons in celebration of Memorial Day. I set up a trail camera across the street...
    Next morning, he proceeded with his daily dirty deed, and we've got him on sequenced, time-stamped, and dated footage clearly in criminal trespass with obvious malicious property damage intended on an easily defined corner location of our property. In addition, this poor Bozo is driving what is clearly a placarded, logo-identified company vehicle. At minimum, I figure this is worth an apology to the selectman candidate with a contribution for disrupting his campaign, an apology to the local VFW for running over the US flag, an apology to my wife for putting up with his BS...along with some renumeration for costs and time lost. But it also occurs to me that repetitive poor judgment in a company vehicle could easily cost this guy his job, points on his driver's license, and inflated insurance premiums. Should I hang this guy or what?

  • Reply to

    Cabo dose adjusting to optimize response

    by wilderguide May 24, 2014 11:35 AM
    wilderguide wilderguide May 24, 2014 3:11 PM Flag

    $$$$
    FWIW - the level of evidence already provided by the published P2 RDT mCRPC results has likely already accounted for some measure of OL prescription. In addition, the CME literature indicates that Cabo is slowly being absorbed into the approved literature based upon that P2 expansion cohort being halted for early efficacy. For some oncodocs, evidence-based medicine is what truly matters...
    That said...should Comet-1 results warrant, we might actually see an early unblinding of Comet-2. At that point, application could be made to the NCCN, and their compendium guidance amended to reflect near-term evidentiary guidance for improved OS and pain relief for payers of insurance coverage. The greatest measure of commercial success for any drug occurs when we all agree as to who's going to pick up the tab. A category 1 listing in mCRPC for Cabo during 2014 would be a great victory for EXEL, particularly if that category 1 is earned thru indisputably superior Comet-1 results. News of this magnitude would warrant a shareholder keg party. Unlikely, but entirely possible...

  • Reply to

    Cabo dose adjusting to optimize response

    by wilderguide May 24, 2014 11:35 AM
    wilderguide wilderguide May 24, 2014 2:30 PM Flag

    $$$$
    "Will they have to wait for Comet 2 before NDA for prostate cancer? "
    No. I would think EXEL's strategy would be to go for an initial SNDA filing in mCRPC pending successful Comet-1 outcomes, and then, after Comet-2 results display further benefit, they would simply add pain-relief data to the product labeling. The many NCI-sponsored trials designed to further define the bone phenomenon may elicit further label changes downstream, as Cabo's impact on bone biology is better understood. Interestingly, in the #2 case review in the Kapur reporting, both bisphonphonate administration and Zoledronic acid were discontinued due to ONJ, but Cabo (also known to perpetuate ONJ) was continued...more good news, I think.
    FWIW - I expect both Comet trials to meet their respective endpoints. Comet-1 by a close margin, Comet-2 by a landslide, comparatively speaking.

  • Reply to

    Cabo dose adjusting to optimize response

    by wilderguide May 24, 2014 11:35 AM
    wilderguide wilderguide May 24, 2014 1:59 PM Flag

    $$$$
    Salty, these are all really pertinent questions, and (I think) difficult to provide credible answers for without proffering an outward presumption of knowing more than I really do...but FWIW, I do have a take on this topic, and here it is...
    For cabozantinib to realize commercial success, it will necessarily need to enter the evolving treatment algorithm in mCRPC and gain an assured measure of clinical acceptance. This will take time -as the adoption, integration, and best sequencing of Abi, Enzalutamide, RA-223, etc are not yet fully determined. The unprecedented recent approvals of a treasure-trove of therapies in mCRPC will be the determining factor...and may itself evolve occasionally as the biology of the underlying disease is better understood. Again, this takes time, money, research...
    On the upside of this topic, Cabo has displayed great potential for conferring benefit in many salvage indications and adoption may speed as refractory patients display unmet need. Keep in mind, with each new application of a therapy, the underlying pathology may itself be changed to a degree that the current therapy itself changes the scope and direction of all future therapy for any given patient. I see Cabo as a successful salvage therapeutic, perhaps gaining in earlier stage treatment endeavors as lower dose efficacy is further explored.
    Again, I firmly believe the commercial advantage for Cabo lies in the co-development of a companion diagnostic to definitively enrich the pool of clinically successful outcomes. Cabo is not alone in the regard, as many targeted agents will "feel the need" for a best, most needful targeted group. There are a lot of great drugs in development, and the treatment algorithm may perceptibly change with each new approval - as may the underlying disease biology evolve in response to newer therapies.
    In a nutshell, there are a lot of unknown variables to consider.

  • Reply to

    Cabo dose adjusting to optimize response

    by wilderguide May 24, 2014 11:35 AM
    wilderguide wilderguide May 24, 2014 12:29 PM Flag

    $$$$
    Nearly forgot, but worthy of mention...both these case reviews are of patients that were determined to be RET negative. If you recall, the EMA EPAR makes note that Cabo prescription could display somewhat less than vigorous patient benefit in the absence of the RET mutation. These two well-documented advanced MTC cases are clearly outliers in direct antithesis to that regulatory consideration. I figure this will bode well for Cabo's next annual review in Europe.