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Exelixis, Inc. Message Board

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  • 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

  • I spoke to people at Exelixis. They told me they had talked to that guy after his report. He doesn't understand; is what I was told. Also they told me to be patient and June 1st etc. we will hear the true results, to date, for Metero and the Roche trials. Orals will be right up to the moment and add info. the Abstracts don't contain. So there you have it. If you want facts or question some reports or post by outsiders go to the source; Exel.

  • What kind of week can we expect to see from EXEL, well ExplosiveOTC is following their developments and those of a handful of potential blockbusters, find out who the next breakout star will be and when you sign up you'll receive an incredible ebook- just enter the code EXEL.

  • Place into interest search: Deep Capture tag Lazard

    Focus on paragraphs beginning with:
    "But, often hedge funds"

    Also listed are players

  • Reply to

    Steifel article

    by maddiemagnolia May 22, 2015 7:43 AM

    Hmmm. OK, a few things. First the trial is for Cabo, not Cobi. Second, the article never said that the toxicity is too high. What it said is, "Data in NSCLC supports cabozanitinib activity but at the cost of potentially excessive toxicity". They go on to say that it is their 'contention' that 60mg may be too high. Potentially too toxic and their contention its too toxic, is a lot different than it 'is' too toxic. Third, I'm not sure how you concluded from that article he is 'well informed on EXEL'. He may be, but nothing in that article tells me he is informed or not informed. Unless of course you are concluding he is 'informed' only because he posted an opinion. Fourth, what 'due date on May 29th' are you referring to? Hint: there is none. It was recently announced that the 'due date' as you call it will be end of Q2 (that's June in the Anglican calendar) or early Q3. So you are only off by 4-8 weeks. You previously called out your intention to sell EXEL so go if you need to justify that sale by posting here so you can re-read it to convince yourself, you can do that just as easily by creating a WORD document and re-reading that. You'll feel just as good. But it seems to me that you are wholly uninformed, and taking advice from someone you have no clue is informed or not. So good luck with that. But even a blind squirrel finds a nut sometimes, so maybe it will work out for you..

  • Reply to

    E1512

    by wilderguide Apr 16, 2015 5:14 PM

    $$$$
    Here's what we know, based on the info divulged in the 11/4/14 press release:
    "In the E1512 trial, 125 patients were randomized to one of the three arms: erlotinib, cabozantinib, or the combination. During a pre-planned interim ECOG-ACRIN Data Safety Monitoring Committee analysis for futility, it was found that the trial met its primary endpoint of improving progression-free survival (PFS) with cabozantinib alone and also with the combination of cabozantinib plus erlotinib, as compared to erlotinib alone, and the results were highly statistically significant. Safety data were consistent with those observed in other trials of cabozantinib. At time of analysis, the median follow-up was 5.9 months and overall survival data were immature.
    The results of the trial are the subject of ongoing analyses and will be submitted by the investigators for presentation at a future medical conference."

  • $$$$
    This study - sponsored by the NCI, and chaired by Doc Joel Neal of Stanford - is the P2 Cabo NSCLC trial that reported positive top-line results on 11/4/14. In that EXEL PR, presentation at future venue was suggested. A quick review of revised updates to this study reveals that the study has been updated nearly each day of this month. Color me optimistic, but if we don't get news regarding this study during tomorrow's market, I think we are in for show-stopping news come Saturday. Oughta make for an interesting Monday...hope y'all have taken advantage of this pullback.
    FYI - the ELCC 2015 news site updates regularly during the conference. It's an easy Google...GL

  • $$$$
    Despite your recent success in publishing "Under the Bleachers"...
    You are still inclined to share your advice here? Another of your misanthropic endeavors doomed to failure.
    Do yourself a favor - find a nice gal. Settle down... Spawn little Seymours... Yer job here is done.
    Your short posture is toast. CMETi is about to become an important part of the equation. You've lost.
    Hasta la vista, Seymour...

  • It's interesting that this recently released article about Matt Smith's presentation doesn't say something like "Cabozantinib Fails Phase 3..." but there will be a better read on sentiment once I see what other sites title theirs and what Smith says in an interview. Gisela in the cc said that failure in OS was probably due to development of Cabo resistance and use of salvage therapy but this wasn't explored in the article.

    Interestingly HR for median time to first SRE in Cabo (HR=0.62, p less than 0.001 from David Miller) was better than Xofigo (HR = 0.66; 95% CI, 0.52- 0.83; P less than 0.001 from "Updated Phase III Data Show Radium-223 Significantly Improves Survival, Extends Time to First SRE"). Xofigo was probably used much longer than Cabo because of mild side effects and thus improved OS; its trial patient population wasn't as refractory either.

  • Reply to

    The Tell

    by duckduffer May 1, 2015 11:36 AM

    "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."

    Let's look at this. We have a definitive statement that as of the end of April, 259 events had not occurred, but we are very close to that milestone. Some other things we know. The event trigger is 259 of the first 375 enrolled, which is a rather high 70%. This was done intentionally to capture data from that significant minority of patients who have been shown to do very well on a second VEGF TKI like Cabo. A smaller percentage would capture data only from the early progressors. The full 375 enrolment was reached in June and the median enrolment for the 375 occurred in April 2014. The mean time on trial for the 375 has not been discussed, but as the trial first opened in 2013, I suspect that mean (numeric average) time on trial is somewhat longer than the reported median. From its phase 3 pivotal trial, everolimus patients experienced a median PFS of 5 months. Looking at the KM graph for that trial, 70% of the patients had progressed by 8 months, however the curve had flattened out such that 80% progression extended out to 11.5 months. So, statistically we can expect some variability on duration of treatment before 70% of the everolimus patients would progress. If the Meteor result is consistent with the everolimus pivotal trial, 8 months is likely, but 10 months is still plausible.

    So lets back up and conservatively use 5/1/2014 for a starting point. The everolimus arm had 8 months on trial by 12/31/2014 and 10 months on trial by 2/28/2015. So, if the everolimus arm is performing consistent with historic results, then the Cabo arm outperforming the control has contributed at least an additional 2-4 months prolongation to the trigger date.

  • $$$$
    This ASCO poster presentation could also prove of value. The following excerpt appears in the Am J Nuc Med Mol Imaging 2015 5(1) 72-82: MGH Cabo PI Chris Sweeney is a co-author...
    "Our data suggest that baseline 18F-FDG-PET/CT may identify men with mCRPC who are likely to benefit from cabozantinib and abiraterone therapy more reliably than standard imaging. Further, 18F-FDG may be superior to 18F-NaF in this patient population. Finally, 18F-FDG-PET/CT has the potential to stratify men with mCRPC into 3 groups (widespread 18F-FDG-avid disease, oligometastaic 18F-FDG-avid disease and non-18F-FDG-avid disease) to tailor therapy. A major unmet clinical need in men with mCRPC is the development of biomarkers to identify those who will benefit from therapy while avoiding futile expensive and toxic treatment."
    In the ASCO 2014 Cabo/Abi update, both lowest dose cohorts (20 & 40mg) had patients on therapy for 22 and 23 months, respectively. The premise of the above study stratifies CRPC by baseline imaging modalities, creating the potential for a biomarker-driven patient pool of best responders to Cabo in combo with Abi. Importantly, this study also contains a data set definitively tying baseline imaging (other than bone scan) to survival benefit.

  • I give lots of TKIs...and grade 1-2 toxicities are common. Zytiga has grade 1-2 fatigue (sometimes 3-4) frequently...I am not in the least bit surprised when you ADD two TKis together you get ADDitive toxicities (and hopefully in exchange for that you get synergistic efficacy). Anyone who would expect otherwise is a fool. As I see it these sort of toxicity assessments ahve no relation to either Meteor or the interesting data on single-agent Cabo in EGFR-WT NSCLC (a potential blockbuster indication).
    I am staying long and strong myself, and ignoring the noise.
    Not adding shares mind you, but holding.

  • SHORT INTEREST REDUCED BY 6,937,638 SHARES. DECLINED FROM 59,643,853 SHARES TO 52,706,215 SHARES. About time. Monday should be great day for longs. I believe there was significant covering happening yesterday as well!!! Good luck LONGS, It's about time!!!!! GO EXEL!!!!!!!!!

    Sentiment: Strong Buy

  • There's a lot going on - on social networks. This morning I searched Genentech and searched for current status and talk per Cobi.

    Fund Venture Biotech Guru David Miller is calling for a Roche takeover to happen quick.

    He has said that this would happen 10 ten months ago. - " David Miller elaborates on his view that Roche (RHHBY +1.3%) has a strong incentive to acquire Exelixis (EXEL +10.7%) in order to capture the full margin of the combination therapy cobimetinib and currently-approved Zelboraf (vemurafenib). He says that the combo regimen could reach peak sales of $1B and should be priced at a premium to Glaxo's (GSK -0.4%) inferior offering of Tafinlar and Mekinist. He believes it will establish itself as the standard of care as a first-line therapy for BRAF-mutated melanoma."

    02427893 - A potent and highly selective inhibitor of MEK1 and MEK2, central components of the RAS/RAF pathway. And - A low molecular weight, orally available inhibitor of the activated form of the BRAF serine-threonine kinase enzyme, which is commonly found in melanoma. Both in concept were patented by Exelixis.

  • I recall when the FDA finally approved Cabo for MTC. The pps actually dropped, and did so significantly. The pps was run up by uninformed speculators anticipating the approval without an appreciation for how small the indication is. The MTC approval serves multiple purposes, but profits from this indications may never cover the clinical and administrative costs of approval and marketing.

    So what's RCC worth? Afinitor is the most widely used 2nd line treatment and it is in its peak years in this indication. It pulls in about $100 million per quarter. It is priced at $6k per month and likely treatment duration is about 5 months. Other 2nd line treatments account for about $150 million per quarter making 2nd line RCC and worldwide billion dollar market. If Meteor succeeds, It is not unreasonable to expect Cabo to assume Afinitors current market penetration. It should also be considered that Cabo is a higher priced drug and if superior to Afinitor, per patient treatment duration will be more lengthy. So, if Cabo were to be used over the same patient population, revenue would higher based on pricing and longer use.

    So depending on how convincing the actual results are, approval based on Meteor could result in a revenue range of $400-$700 million annually. IMO this certainly would justify a boost from the present pps. Add in Cobi and renewed speculation about other indications and we could see some decent appreciation from present levels. That's the rosy scenario. A failure on Meteor would see us below $1 per share and Cobi asset would just about cover the cumulative corporate debt. We'll see.

    Abstracts at 5pm.

  • $$$$
    I'm fairly certain I heard MMM say "...we've had some good discussions..."
    After the independent investigators and the NCI log in with new data, post-ASCO could be very interesting...
    I'm beginning to suspect we've graduated beyond SNAFU...my take is we've got some superior data...
    And I say "Bring it, Bagdad Bob." Seymour, are you still with us...??
    I'd love to hear your take at this point, Mr Zero Shareholder Equity...Mr VooDoo medicine...
    What's changed - other than your Dydees - Big Boy?
    GLTA

  • Reply to

    SHORT INTEREST DROPPED SIGNIFICANTLY

    by saltydog711 Apr 10, 2015 5:04 PM

    RIGHT BEFORE CLOSE EXEL HAD SEVERAL NOTABLE BUYS. 1) 28,100 Shares 2) 46,000 Shares 3) 136,000 Shares (Apparently the largest trade of the day) 4) 36,900 Shares & 5) 84,300 Shares. Perhaps we are in for some good news this weekend? Also, 8,000+ $3.50 JUNE CALLS were purchased for between 65-70 Cents!!! NEXT WEEK SHOULD BE GREAT!!!imo.

    Sentiment: Strong Buy

  • On Saturday, May 30th the PFS from CoBRIM should be updated in an Oral Abstract presentation (#9006) which should allow comparision to Novartis' Combi-d-data (#102) for Mekinist/Tafinlar, the first p3 survival data of a MEK/BRAF combination in BRAFm melanoma.

    30-May 3:15 PM - 3:27 PM 9006 Cobimetinib Update of progression-free survival (PFS) and correlative biomarker analysis from coBRIM: Phase III study of cobimetinib (cobi) plus vemurafenib (vem) in advanced BRAFmutated melanoma.

    Oral Abstract Session E354b

    30-May 1:15 PM - 2:30 PM 2573 Cobimetinib Population pharmacokinetics and dosing implications for cobimetinib in patients with solid tumors.

    Poster Discussion

    1-Jun 4:45 PM - 6:00 PM 9033 Cobimetinib Clinical features of cobimetinib (COBI)–associated serous retinopathy (SR) in BRAF-mutated melanoma patients (pts) treated in the coBRIM study.

    Poster Discussion S100bc

    1-Jun 4:45 PM - 6:00 PM TPS9088 Cobimetinib Phase 2 study of cobimetinib in combination with vemurafenib in active melanoma brain metastases (coBRIM-B).

    Poster Discussion S100bc

    1-Jun 4:45 PM - 6:00 PM 9020 Cobimetinib Extended follow-up results of phase Ib study (BRIM7) of vemurafenib (VEM) with cobimetinib (COBI) in BRAF-mutant melanoma.

    1-Jun 4:45 PM - 6:00 PM 9021 Cobimetinib Quality-of-life (QOL) assessment in patients (pts) with metastatic melanoma receiving vemurafenib (V) and cobimetinib (C).

    1-Jun 4:45 PM - 6:00 PM 9033 Cobimetinib Clinical features of cobimetinib (COBI)–associated serous retinopathy (SR) in BRAF-mutated melanoma patients (pts) treated in the coBRIM study.

  • earnings beat doesn't matter. What counts is METEOR data. Make or break.

  • mj5252...earning most certainly have a lot to do with price action. The earings were good they beat execution. This means the company is moving forward in a POSITIVE direction. Earning combined with the expecation of positive trial news is extremely positive. For the shorts and there are a ton - how do you think they feel right now. Earning are not meaningless...where would this stock be if earning met or barely disappointed. They matter!!!

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