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Exelixis, Inc. Message Board

duckduffer 40 posts  |  Last Activity: 1 hour 14 minutes ago Member since: May 29, 2003
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  • Reply to

    Anyone has binary event calendar for EXEL ?

    by annasaaru May 23, 2015 3:12 PM
    duckduffer duckduffer May 27, 2015 12:26 PM Flag

    "I've been mulling over this going concern issue and the lack of 12 months of cash or cash equivalents."

    The most relevant comment on this was from MMM when discussing a partnership. He admitted the company had realized the need to partner with the failure of Comet. This has been mentioned now several times on CC's and is clearly the first action that would occur with meeting RCC endpoints. The value of that partnership will be dependent on METEOR results, as will everything that has to do with valuation going forward.
    The good news is that EXEL doesn't need that much cash. The MRQ showed expense down to $45M. By Q1 2016 I expect Cabo and Cobi combined revenues to exceed $25M per Quarter. The amount of additional cash needed to fund operations through a successful RCC launch (FDA approval before Q2 2016) by my estimates, no more than $50M. Not a tough sell for foreign rights to RCC.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    ASCO Abstracts

    by trufflesdrive May 21, 2015 4:07 PM
    duckduffer duckduffer May 21, 2015 5:14 PM Flag

    Docetaxel's OS HR 0.73 from TAILOR. Cabo + Erlo OS HR 0.50 from E1512. Both studies were vs Erlotinib.
    Just clarifying.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    ASCO Abstracts

    by trufflesdrive May 21, 2015 4:07 PM
    duckduffer duckduffer May 21, 2015 5:07 PM Flag

    In the E1512 EGFRwt NSCLC trial, the OS HR 0f 0.50 for Cabo + Erlo was much better than Docetaxel was in the TAILOR EGFRwt trial. If that can be replicated in a Phase 3, Cabo + Erlo would be a compelling option vs Docetaxel in what is a very large indication. The PFS HR for Cabo + Erlo was also much lower than Docetaxel (PFS HR 0.31 for C+E vs PFS HR 0.71 for Docetaxel).

    GLTA

    Sentiment: Strong Buy

  • Reply to

    Wilder - others

    by snowflakeformationxy May 19, 2015 11:14 PM
    duckduffer duckduffer May 21, 2015 4:33 PM Flag

    Converts are ill conceived when issued at such a price that the eventual conversion to common shares is unlikely. That was the case with DNDN. The company would have required an $8B valuation for conversion to occur. With the modest success of Provenge, the convertibles became the debt that finally forced the company to accept a BK takeover. Much different story here, EXEL's convertibles would only require a valuation of $1.3B, easily attained with strong METEOR results. While it hasn't been fun watching the manipulation resulting from the convertible financing arbitrage as a long holder, it's also not material to the long term valuation of EXEL. The money raised from the convertible offering was necessary to launch the METEOR and CELESTIAL trials. It will be regarded as an unpleasant but necessary strategy should METEOR and/or CELESTIAL pave the way for more FDA approvals in much larger indications than MTC.

    Sentiment: Strong Buy

  • duckduffer duckduffer May 18, 2015 2:58 PM Flag

    "Wouldn't this suggest in a small way that in the MTC patients toxicity is not slowing use"

    Draw you own conclusions, but certainly in this subset of patients from EXAM it's not.

    "For 126 pts with known RET M918T mutations, median OS was 44.3 mo for Cabo vs 18.9 mo for P (HR = 0.60, p = 0.026)."
    and one could surmise that same subset of patients drove the % in this statistic from EXAM.

    "46% and 26% of Cabo-treated pts remained on study treatment for over 1 year and 2 years, and 10% and 1.8% for P, respectively. "

    I think you could conclude, especially with the increasing revenue, that if the treatment is working....it's worth the side effects.

    Sentiment: Strong Buy

  • Reply to

    Stifel stifles Klein's toxic review...

    by wilderguide May 16, 2015 4:03 AM
    duckduffer duckduffer May 17, 2015 7:01 PM Flag

    The timing of that AF piece, after Comet 2 topline, was well before any of the specific data from Comet had been released, other than the failure to hit the primary endpoints. Essentially a blind assessment that based on the Comet failure Cabo's only hope was RCC and it's a "dim outlook" at that. After seeing more specific data, including the clear OS benefit of over 50% vs control arm in patients with visceral mets it's pretty clear that Cabo works just fine in specific patient subsets. We now know the trial design and confounding treatments (cabazitaxel) were responsible for the Comet 1 failure. We also know that in EXAM, the MTC Phase 3, 46% of patients stayed on treatment over 12 months and 26% stayed on treatment over 24 months. Somewhat contradicts the side effect statements made by Stifel. So what can we say for sure about this chap Brian Klein? Despite being an MD, he is willing to make statements that move the PPS without considering all the data in hand or regard for that which is undisclosed. Doesn't sound very much like anything more than YMB speculation.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Levantinib mRCC ASCO 2015

    by dimplesorourke May 9, 2015 10:40 AM
    duckduffer duckduffer May 9, 2015 2:08 PM Flag

    "this compound has the clear potential to be better than cabozantinib..."
    It's interesting, the Phase 2 success was announced January 30th, yet no mention that the results indicate further study is warranted and no pending Phase 3 has been announced. If the data is that compelling, wouldn't we have seen a Phase 3 study announcement, even if it's just in the planning stages by now?

    Sentiment: Strong Buy

  • duckduffer by duckduffer May 1, 2015 11:36 AM Flag

    If you, like me, are always trying to find a "tell" during CC's and investor calls, this well worded statement by MMM has got to be it.
    "While we have noted that the event rate has slowed over the last few months we are very close to having achieved the required 259 PFS events and are in the final steps of data collection, data cleaning and source data verification before running the final analysis."
    That first sentence says it all. What does that blatantly imply? Knowing that everolimus demonstrated 4.9 months PFS in a randomized study (Record 1) with 277 patients on the everolimus arm, should provide a high level of confidence we will see similar PFS numbers in METEOR. MMM was clearly implying, the probabilities are highly favorable that Cabo is performing better than the trial design of 7.5 months. For Cabo to achieve a PFS of say 10 months or greater, with everolimus performing to expectation, is what takes this from a $100M indication to a $500M+ indication. Or in laymans terms, a $6-8 stock to a $15-20 stock.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Wow, important line from report!!!

    by alexp1112 Apr 30, 2015 4:26 PM
    duckduffer duckduffer Apr 30, 2015 4:55 PM Flag

    Keep in mind the control arm, Afinitor, has PFS data from a large Phase 3 trial. Cabo's PFS data, however, is based on a very small Phase 1b trial. Cabo's PFS has always been the wild card. For that simple reason, it is significantly more probable for Afinitor's PFS results to be very close to the trial design. If you take that assumption and extend it to a longer clinical trial, it supports a better PFS for Cabo. I take this as good news.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    XL765 cancelled in ph2 by Sanofi

    by franca_ole Apr 30, 2015 9:47 AM
    duckduffer duckduffer Apr 30, 2015 2:40 PM Flag

    Misleading post franca, makes it sound like XL765 was being returned....not the case...from Sanofi's site...many ongoing studies.

    "SAR245409 is currently being studied in a phase ll study in CLL and NHL. A phase I/II trial is assessing SAR245409 in combination with letrozole in ER/PR+ HER2- breast cancer.

    In two phase I studies, SAR245409 is being assessed in combination with temozolomide in malignant glioma and with another investigational agent, pimasertib,19* in solid tumors. Other phase I studies will assess SAR245409 as a single agent in solid tumors and lymphoma and as combination therapy with rituximab alone or rituximab and bendamustine in CLL and NHL."

    GLTA

    Sentiment: Strong Buy

  • Reply to

    quarterly report

    by jgs3rd Apr 30, 2015 12:53 PM
    duckduffer duckduffer Apr 30, 2015 2:32 PM Flag

    Reported same time frame last year for Q1. Nothing to see here. Move along.

    Sentiment: Strong Buy

  • Reply to

    ipilimumab Plus nivolumab "dissolves tumor"

    by socialidiocies Apr 28, 2015 4:42 PM
    duckduffer duckduffer Apr 29, 2015 9:21 PM Flag

    "a 46% chance having the tumor disappear with a single treatment, would you take the chance with treatment?"
    Is it possible you are overstating the efficacy just a bit there. 46% of the patients had their tumors "disappear"?

    Sentiment: Strong Buy

  • duckduffer by duckduffer Apr 24, 2015 1:23 PM Flag

    longer is better. That wasn't the case with Comet, as OS can be significantly confounded with follow on therapies (for Comet, Cabazitaxel was the likely culprit). But METEOR has a primary endpoint of PFS. There isn't the possibility of confounding subsequent therapies with PFS. Thus we can more confidently assume the PFS data assigned to the Afinitor arm will be close to expectations. Thereby the longer it takes for the minimum number of PFS events... we can more confidently assume it will demonstrate better PFS performance from the Cabo treatment arm.Hence IMO, in this case, the longer...the better...
    GLTA

    Sentiment: Strong Buy

  • Reply to

    ASCO 2015

    by saltydog711 Apr 14, 2015 10:21 PM
    duckduffer duckduffer Apr 23, 2015 12:31 PM Flag

    How do you correct pure speculation? We don't know specifically when each patient enrolled and we don't know if the actual trial PFS for either treatment arm is consistent with the trial design.

    Sentiment: Strong Buy

  • Reply to

    E1512

    by wilderguide Apr 16, 2015 5:14 PM
    duckduffer duckduffer Apr 17, 2015 6:34 PM Flag

    "if we don't get news regarding this study during tomorrow's market, I think we are in for show-stopping news come Saturday."
    Hallelujah. EGFR wild type Stage 4 NSCLC is not a little deal. Eighty percent of lung cancer patients have wild type EGFR. Forty percent of patients with newly diagnosed non-small cell lung cancer (NSCLC) have stage IV disease. Estimated new cases of lung cancer (NSCLC and SCLC combined) in the United States in 2014,........224,210.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Meteor Test Result bar to hurdle

    by ulingt Apr 17, 2015 8:36 AM
    duckduffer duckduffer Apr 17, 2015 5:34 PM Flag

    You are confusing stage IV EGFR wild-type non-small cell lung cancer (NSCLC) in E1512, with RCC in METEOR. Two different cancers, two different trial designs.

    Sentiment: Strong Buy

  • Reply to

    Meteor Test Result bar to hurdle

    by ulingt Apr 17, 2015 8:36 AM
    duckduffer duckduffer Apr 17, 2015 12:25 PM Flag

    Per the last CC, Gisela Schwab indicated the average dosing for the Phase 1B trial you are referring to was 70mg. Not much of a difference from the initial dosing of METEOR of 60mg and likely beneficial in terms of AE's.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Fast Track % - Snowflake was wrong...very wrong

    by ulingt Apr 9, 2015 3:34 PM
    duckduffer duckduffer Apr 9, 2015 6:30 PM Flag

    In the case of Cabo, it was Fast Tracked and approved in MTC. Cabo did not get Fast Track designation for Comet 1/2. So far, Fast Track is a 100% positive indicator for Cabo approval.

    Sentiment: Strong Buy

  • Reply to

    Fasttrack, and what it means.

    by oncodoc02138 Apr 9, 2015 1:29 PM
    duckduffer duckduffer Apr 9, 2015 6:23 PM Flag

    Per the below pasted from the FDA website "unmet need" includes superior effectiveness ie efficacy. In the case of RCC, there are plenty of TKI's as current therapy. As such wouldn't it be safe to assume the potential for superior effectiveness "efficacy" is a factor here?

    Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.

    Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:
    •Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
    •Avoiding serious side effects of an available therapy
    •Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome
    •Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment
    •Ability to address emerging or anticipated public health need

    Sentiment: Strong Buy

  • Reply to

    Fasttrack, and what it means.

    by oncodoc02138 Apr 9, 2015 1:29 PM
    duckduffer duckduffer Apr 9, 2015 2:32 PM Flag

    While Fast Track approval has zero implication the FDA believes the trial will meet endpoints, it was still a surprisingly positive development. Many on this board (you know who you are) thought the approval process even with great data would be lengthy with a significant delay to market. I'm frankly surprised at this development simply because there are so many TKI's already approved for RCC. This tells us one thing for certain....the FDA agrees that the earlier trial data was compelling enough that if replicated in METEOR, Cabo will have demonstrated superior effectiveness to the existing SOC. That in and of itself is good news and should not be discounted. Now we just need good data.
    GLTA

    Sentiment: Strong Buy

EXEL
3.485-0.275(-7.31%)1:50 PMEDT