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Inergy, L.P. Message Board

wilderguide 249 posts  |  Last Activity: Jun 30, 2015 12:51 PM Member since: Jan 13, 2011
  • $$$$
    FYI -
    Section 3.2 Initial applications : Day 180 list of outstanding issues
    3.2.1 Cobimetinib EMEA/H/C/ 003960
    Treatment of Metastatic Melanoma
    Scope: For adoption
    LOQ adopted 1/22/2015
    JMO - Barring clock stoppage, this conceivably suggests that we are approx within a 30 day window to an EC opinion announcement. This timeline should inspire some near-term handicapping of Cobi approval in Europe.

  • $$$$
    Price going higher...
    It's like Déjà Vu all over again.

  • Reply to

    What if...

    by hensley_1957 Jun 19, 2015 10:54 AM
    wilderguide wilderguide Jun 21, 2015 1:32 PM Flag

    $$$$
    Lions and tigers and bears...oh my...
    Have the best week, Drizzlebritches...
    Meep! Meep! My self-flagellating friend...

  • wilderguide wilderguide Jun 21, 2015 11:27 AM Flag

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    "...use this trial...to move Cabo to first line RCC?"
    I see this as unlikely, given the relatively small trial population. That said - one of the tertiary outcomes being monitored in this trial is to explore the correlation between MET expression and PFS/OS in stage III/IV disease. This information could provide the rationale to inform some frontline decision-making and perhaps a future pivotal trial. Once approved, I think payers will agree to pay, particularly if the prescription rationale is supported by reasonable biomarker analysis. This type of subset prescription might be best enabled by application to the NCCN for compendium listing rather than additional pivotal analysis. JMO, but I'm a big fan of biomarker guided therapy, and see a future in which treatment decisions are informed by trial results and confirmed by liquid biopsy. It's no great stretch to see that insurers may insist on such procedural adherence as requisite to optimal coverage.

  • wilderguide wilderguide Jun 20, 2015 8:18 AM Flag

    "How does...orphan status for Ocular melanoma affect any progress in this area."
    Worth paying attention to...but unknown at this time. Remember that orphan status is granted upon application with criteria of unmet need - proof of treatment efficacy is not required, so the importance of the orphan designation may not preclude outside competitor development. For the most part, I see orphan status as a tool to defray development costs and grant tax benefits, rather than an indicator of treatment benefit. The tax breaks and extended exclusivity make OD a sound part of any well-planned drug development strategy - regardless of whether the orphan indication proves viable or not...

  • wilderguide wilderguide Jun 20, 2015 7:28 AM Flag

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    "Could be there was an interim analysis..."
    I also considered this, Neers...two other NCI-sponsored studies are suspended for assessment - the refractory DTC and ocular melanoma trials. To the best of my knowledge, the NCI has no requirement to publish trial designs, interim analyses, scheduled assessments, etc... As a result, we may never know for sure. But, I would consider it a positive if these trials continue to receive funding beyond these temporary closures. I would also pay close attention to shifts in protocol if these trials reopen. To my way of thinking, the CABOSUN trial is especially,susceptible to protocol shift, as its data could actually change clinical perspective of the SOC. Some pretty revealing potentials there...I think your observation could be spot on...

  • Reply to

    What if...

    by hensley_1957 Jun 19, 2015 10:54 AM
    wilderguide wilderguide Jun 20, 2015 7:05 AM Flag

    $$$$
    Simps, pimps, and wimps...
    Fools, tools, and jewels...
    Duds, cruds, and FUDs...
    Cranks, skanks, and Yanks...
    Just makin' sure not to exclude anyone...
    Let the good times roll, Nancy-boy...

  • Reply to

    What if...

    by hensley_1957 Jun 19, 2015 10:54 AM
    wilderguide wilderguide Jun 20, 2015 1:52 AM Flag

    $$$$
    "Pedophiliacs, suicidals, homophobics..."
    Trans-genders, liars, thieves, cross-dressers, multiple personalities, twirps, dummies, wackjobs, pudd-pullers, cubicle jockeys,
    Bring 'em all...I think everyone here would like to meet yer family and friends...
    I certainly know it would bring me a great deal of joy getting to know those closest to you.
    Bring 'em...I'll even buy the beer. Let's party, nancy-boy...

  • Reply to

    What if...

    by hensley_1957 Jun 19, 2015 10:54 AM
    wilderguide wilderguide Jun 19, 2015 2:19 PM Flag

    $$$$
    BTW - I gave you the thumbs-up. Feel better?

  • Reply to

    What if...

    by hensley_1957 Jun 19, 2015 10:54 AM
    wilderguide wilderguide Jun 19, 2015 2:15 PM Flag

    $$$$
    "What if..."
    What if Nomad posted and no one even bothered to respond?
    Would he develop a permanent boo-boo lip, and quit taking the time to share his valued message?
    Would we lose out on the pleasure of his company? Would he shun our friendship?
    Would he become so despondent as to commit the unmentionable?

  • Reply to

    BLOCK

    by saltydog711 Jun 18, 2015 11:48 AM
    wilderguide wilderguide Jun 18, 2015 2:05 PM Flag

    $$$$
    "Maybe you should go to Area 51..."
    Ancient alien astronaut theorists and MUFON founders concur that there may exist an extraterrestrial plot to undermine the global economy. Targeting this theory, the consensus of opinion claims this may be a conspiratorial cadre represented by an irrational and over-exuberant short element within the global marketplace. How about it, Seymour...???
    Which side will you be on when the big balloon goes up?
    Will you stand in the light, or will the dark side encompass you?
    Inquiring minds really wanna know yer opinion...
    Regardless of how boneheaded it may be...

  • Reply to

    Another Options expiration week...

    by captainhymanshocker Jun 17, 2015 10:11 AM
    wilderguide wilderguide Jun 18, 2015 6:31 AM Flag

    $$$$
    "Where do I sign up to fish..."
    Summer fishing on the Wasatch can be the best. I've fished below Deer Creek Reservoir along the Bonneville Trail and off Provo Canyon Rd from Provo to Santaquin. Bonneville cutthroat natives and brown & rainbow stockers comprise the local game fishing. The Utah Fish and Game Dept and the Richfield Ranger District (NFS) post local fishing reports and area closures with regular updates.
    In years past I was a regular on the Fish Lake, and fished the Blue Ribbon hatchery E Fork Sevier in Kingston Canyon to Otter Creek Reservoir many times.
    Really rugged country beyond Antimony Creek, but worth the effort.

  • Reply to

    Another Options expiration week...

    by captainhymanshocker Jun 17, 2015 10:11 AM
    wilderguide wilderguide Jun 17, 2015 12:16 PM Flag

    $$$$
    "Company needs to grow some balls."
    This is a message that needs to be carried to the attention of IR, with CCs to CEO MMM & CFO Burke - with performance enjoinders to ensure it happens to Papa Stelios and the BOD.
    I like it. Where do I sign up for this program?

  • Reply to

    Foretinib, AXL, and CRC

    by wilderguide Jun 13, 2015 12:07 PM
    wilderguide wilderguide Jun 16, 2015 3:22 PM Flag

    $$$$
    "Should have been..."
    Shoulda woulda coulda...
    ...and you coulda been a poster child for birth control. Still could be...
    All decked out in a full body condom with decorative IUD body piercings...
    Funny how we miss out on our true callings...

  • Reply to

    Scuzzbucket traffic is up...

    by wilderguide Jun 15, 2015 7:02 PM
    wilderguide wilderguide Jun 16, 2015 12:34 AM Flag

    $$$$
    My bad, doc. The hellgrammite is the larvae of the Dobson fly.

  • Reply to

    Scuzzbucket traffic is up...

    by wilderguide Jun 15, 2015 7:02 PM
    wilderguide wilderguide Jun 16, 2015 12:18 AM Flag

    $$$$
    I've fished the Kern, and done well baiting with the local hellgrammites - the aquatic larvae of the Stone fly. Past experiences have prompted me to carry a 12x24" 1/4" galvanized screen in my fishing pack. If you prop it up between two creek stones in a fast water flue, go upstream and turn over some of the bottom rocks - it'll temporarily muddy the water, but it'll feed your capture screen.
    A large, hardy hellgrammite has caught up to 4 fish for me before it was exhausted...
    They are nearly indestructible, and some of the best fish bait I have ever witnessed. GL doc...

  • Reply to

    Scuzzbucket traffic is up...

    by wilderguide Jun 15, 2015 7:02 PM
    wilderguide wilderguide Jun 15, 2015 10:38 PM Flag

    $$$$
    Hi neers87,
    If you recall, Cobi was also on the Jan 15 PRAC agenda. If there were outstanding issues, I feel they'd have been addressed by now. I have no real further evidence, just a gut feeling based on the timeline relative to the known 9/14 filing. Without information regarding "stop clock" scenarios, we can only guess at a date for EC opinion. No doubt we are very close, and the great data presented at ASCO makes for good early review conjecture. Inasmuch as I'd like to see confirmation with this coming weeks' CHMP meeting, we may have yet to wait as their plate is very full. Interesting times lie directly before us, and toying with the cubicle monkeys fits my pistol, so I'm playing their game. Beats dominoes...

  • Reply to

    Scuzzbucket traffic is up...

    by wilderguide Jun 15, 2015 7:02 PM
    wilderguide wilderguide Jun 15, 2015 9:30 PM Flag

    $$$$
    Stay ready to bend over & grab 'em, Nomad...
    Yer about to get your optimal quarterly fix of sorassenib...
    If it hurts a bit...be sure to grunt for us...
    Just like the last time yer Daddy drove you home...

  • $$$$
    There may be improvements ahead...

  • Reply to

    This is MANIPULATION!

    by semanresu Jun 15, 2015 10:06 AM
    wilderguide wilderguide Jun 15, 2015 11:02 AM Flag

    $$$$
    "Look who's talking!"
    Biblical scholars and ancient alien astronaut theorists recommend against finger-pointing as a repetitive defense mechanism, lest you are willing to reveal to the masses where that finger has been... In yer case, I'd rather not know thank-you-very-much.