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Inergy, L.P. Message Board

wilderguide 181 posts  |  Last Activity: 2 hours 46 minutes ago Member since: Jan 13, 2011
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  • Reply to

    Cowen CC

    by erniewerner Mar 8, 2016 5:43 PM
    wilderguide wilderguide Mar 8, 2016 6:42 PM Flag

    $$$$
    Hey Ernie - thanks for weighing in on this conference. I've stopped listening to them. They've proven nothing more than a source of continued disappointment. The more Mike yacks, the more the stock decimates. As you know, I've long contended that the Apolo NCI trial could be amongst the most important for EXEL's future well-being, and you've just reinforced my gut feeling in this...
    Dr Apolo has openly touted Cabo response rates in bladder cancer, and openly claimed unprecedented disease regression amongst her most treatment-refractory patients with Cabo. However, whatever she's seeing in the Nivo/Ipi/Cabo combo trial is being played very close to the vest. Not a word can I find...
    The rationale appears intact, but we've all seen rationale fly south...
    I'd like to see a Cabo/Cobi combo trial - perhaps in CRC or a lung indication. There are some relevant presentations of viable rationale, and this JV funding might be a good opportunity to get a POC trial funded.
    Any thoughts?

  • Reply to

    No data in celestial (HCC) till 2017

    by hum14jbird Mar 8, 2016 12:15 PM
    wilderguide wilderguide Mar 8, 2016 1:25 PM Flag

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    "...they have made the comparator mistake before..."
    Meanwhile, back at the ranch...the trial to pay attention to is NCT01761266 - Lenvatenib vs Sorafenib in frontline HCC. Nivo is also recruiting a viable P3 - head-to-head with sorafenib...a combo P2 trial with Ipi...and a POC P1 study in combo with galunsertinib - all in HCC. Breakthrough results in any of these studies could easily be seen to compromise CELESTIAL...

  • Reply to

    Can Ipsen buy out the rest of EXEL?

    by enabeler Mar 8, 2016 9:27 AM
    wilderguide wilderguide Mar 8, 2016 1:06 PM Flag

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    "OS is an integral component of the sales viability."
    The timing of the JV announcement was no coincidence. I see a high likelihood they had made a prior agreement predicated on satisfactory OS reporting.
    "The PPS is being played..."
    These are the truest of words that will be posted today...

  • Reply to

    No data in celestial (HCC) till 2017

    by hum14jbird Mar 8, 2016 12:15 PM
    wilderguide wilderguide Mar 8, 2016 12:26 PM Flag

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    I suspect recruitment has been handicapped by a placebo comparator. There are currently many HCC trial options that offer viable theoretic treatment as a control.

  • Reply to

    Is trading this for sustained upside a pipe dream?

    by yhoopoke Mar 8, 2016 10:47 AM
    wilderguide wilderguide Mar 8, 2016 11:47 AM Flag

    $$$$
    "Without a buyout offer, everything is built in. If CELESTIAL fail, you can see this go under $3."
    "A buyout might be over $10..."
    Whatever the true nature of the debt negotiation as proscribed by former CFO Frank Karbe, it can almost certainly be said to have created a revenue-dependent biotech equity. Up in a down market...down in an up market...down on good news...up on no news...
    A more contrived market capitalization is difficult to imagine, as share price is disconnected from historic biotech value drivers. The stock has become a trade vehicle to sustain the convertible holders, make a fistful of dough for the market makers, and create boundless options value for upper management. Predicting this stock's value is much like predicting next years' weather for a specific day, and that is not likely to change till the converts are compelled to become common shareholders. Until that time - covert, stealthful wealth-making will prevail by the MMs, the converts are free to safely keep SP range bound and below $6.91, and insiders will continue to collect on quarterly RSUs, options, and merit bonuses. Negating retail shareholder value was the trade-off made to satisfy the renegotiated debt. Do I see predators lurking in the shadows? Yes, I do...

  • Reply to

    Can Ipsen buy out the rest of EXEL?

    by enabeler Mar 8, 2016 9:27 AM
    wilderguide wilderguide Mar 8, 2016 10:30 AM Flag

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    "...if the OS#s are better than expected..."
    Those #s have been submitted to both the FDA and the EMA for labeling inclusion, and each agency has a commitment to expedite superior products to market. The EMA's PRIority MEdicine (PRIME) program was initiated only just yesterday (3/7), and specifically addresses products already enlisted by their accellerated assessment program. I think we can conclude that if superior survival benefit is gainfully obvious, the regulatory agencies can be expected to pace up a notch or two. We shouldn't have to wait much longer, and I suspect Ipsen's political connections might hasten an EMA review - especially if Cabo OS in RCC has bested existing treatments.

  • wilderguide wilderguide Mar 6, 2016 6:26 PM Flag

    $$$$
    "Oh Captain, my Captain..."
    Hopefully, prosperity is just around the corner...

  • Reply to

    EAU 2016 Munich

    by wilderguide Mar 2, 2016 2:03 PM
    wilderguide wilderguide Mar 4, 2016 2:36 PM Flag

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    EXEL is not listed as an exhibitor. However, Ipsen will have exposure in booth D42.
    Floor plan and exhibitor list is available on request...

  • $$$$
    If BMY offered $10B for the whole shebang...
    It seems we would revisit the $2s...
    Welcome to share price du jour, a wonderland of unknown market capitalization...
    Who's the Bozo driving this bus?

  • wilderguide wilderguide Mar 3, 2016 3:54 PM Flag

    $$$$
    Of particular interest to me is the commentary regarding correlation of HGF, MET, and Axl to PFS1L. The rationale indicates favorable outcome for Cabo in first line, though superiority to sunitinib may yet be a reach in the absence of comparative data. As treatment-induced resistance to sunitinib becomes better understood, rationale for Cabo in post-sunitinib pts may also gain support.

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    "Circulating biomarkers and outcome from a randomised phase II trial of sunitinib vs everolimus for patients with metastatic renal cell carcinoma." Voss et al. BJC Feb 23, 2016
    Some interesting results from a large P2 trial primarily powered toward non-inferiority PFS in untreated pops. The composite biomarker score differences between treatments may provide some insight into CABOSUN results.

  • Reply to

    Next ER will clearly be historic

    by wilderguide Mar 3, 2016 2:00 AM
    wilderguide wilderguide Mar 3, 2016 8:10 AM Flag

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    Largest cash infusion in the company's history along with what may also reflect record revenues from two globally approved drugs being prescribed and covered by insurers in as many as four indications.

  • $$$$
    Yet I suspect share price will flounder, exposing this manipulative charade beyond belief...
    Where's that freekin' caped crusader when you need him?

  • wilderguide by wilderguide Mar 2, 2016 2:03 PM Flag

    $$$$
    Just a heads-up...
    On-line abstracts become available 3/11/16...

  • $$$$
    Ipsen just last winter cut a $137M deal with Telesta for European rights to the immuno modulator MCNA. The FDA issued a CRL in early Feb with notice of rejection on the 27th. The Cabo deal was announced on the 29th. An MAA is on file pending EMA review by Telesta in NMIBC. Any thoughts on compatibility of MCNA in combination with Cabo ? Ipsen may have the political clout to gain overseas approval for MCNA, and if the science is a good fit, I wonder if they (ipsen & Telesta) are inclined to explore a new combo in the interest of damage control? Any thoughts?

  • wilderguide wilderguide Feb 28, 2016 11:26 PM Flag

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    Here's the title of that PracticeUpdate. I wanted to make sure you had access...
    "Embracing the Emerging Treatment Landscape of Metastatic Renal Cell Carcinoma: Assessing How Patient Care will Change in Community-based Oncology Practices" I think this segment produced in Oct 2015... Dan George, Sumanta Pal...some easily noted KOLs...
    Vogelzang makes some interesting commentary regarding declined insurance coverage for Nivo...and is surprised to get Cabo approval - of course neither approved in RCC. He also has some interesting comments wrt a successful 5th line of therapy re-challenge with sunitinib. You can't make this stuff up, and it's a wonderment of rationalized exploration. I consider this roundtable a rare find. You don't see comments like this often enough. It's very compelling...

  • wilderguide wilderguide Feb 28, 2016 5:25 PM Flag

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    Ernie, thanks for sharing commentary here...
    In the past few weeks, a PracticeUpdate roundtable session has Doc Vogelzang sharing commentary on an RCC patient he started on a 20mg dose schedule. Patient response was enumerated as near immediate, and that patient had remained on-drug for several months progression-free & apparently doing well. Cabo's notable toxicity makes this approach very sensible, especially for at-risk ECOG profiled RCC pts. IYO, would additional dosing studies be an imperative to adopting this approach, or is the need for titration (upward or downward) normally included in labeling. I like this approach a lot, and feel it has not received the exposure it deserves. Any comment you can share? TIA

  • wilderguide wilderguide Feb 28, 2016 2:59 PM Flag

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    I've been struggling with a simpler description of the point I've been attempting, and think I may have hit on it...
    As I see it, in the absence of a Level 1 evidence there seems to be an increasing receptiveness toward population-based, population-defined data, and that population-based data pool is ever-increasing as cancer trial data is entered into aggregated data pools, ie the National Cancer Data Base, Watson, etc...
    Recent publications by Dana-Farber suggest gainful insights into MET expression (Understanding the Pathway, Awal et al JCO Jan 2016) are imminent. JMO - I feel Cabo is in a good spot for improved understanding of MET regulation in disease progression across the spectrum of cancer indications. GLTA

  • wilderguide wilderguide Feb 28, 2016 11:32 AM Flag

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    "Cabo may get another shot at CRPC, but my guess is that it will be in a much more narrowly defined population..." This is a point I've contended for some time and I feel it's worthy of ongoing discussion, as it is pertinent to all onco-treatments. Trial analysis lends primary lip service to primary endpoints, regardless of the increased understanding gained via secondary, tertiary, and biometric endpoint analytics. With this in mind, I feel one of the more important endpoints in CABOSUN lies in correlating MET expression to PFS & OS within the trial-defined histology. In addition, though both COMET trials missed their primary goals, I feel it's very important to look beyond those failures for the value gained in disease understanding via clinical critique. Recent PCWG3 recommendations could actually change the prostate approval threshold favorably for drugs like Cabo - perhaps creating a filing niche for existing data - particularly wrt evolved understanding of the underlying biometrics of disease progression. There's still a lot of spadework ahead...

  • wilderguide wilderguide Feb 27, 2016 3:20 PM Flag

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    "The thing about CaboSun is it is just too small..."
    The Lenvatenib/ Everolimus P2 filing is smaller still, yet moving forward. The evolving treatment landscape in RCC appears to bend the rules a bit - early approval of Nivo, low-ball patient-numbers P2 data filing accepted for Lenvima, breakthrough designations every which way you look. If Cabo can catch a break here, I think the aggregate of data will speak volumes with good return from CABOSUN and other relevant NCI analyses. Post-adoption of PCWG3 recommendations, I'm still expecting to find a niche in the prostate space.
    I guess you can color me optimistic...