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VirnetX Holding Corp Message Board

duckduffer 188 posts  |  Last Activity: May 1, 2015 11:36 AM Member since: May 29, 2003
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  • 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

  • Reply to

    Since the Comets

    by duckduffer Mar 29, 2015 2:09 PM
    duckduffer duckduffer Mar 30, 2015 12:42 PM Flag

    "Duck...you have any thoughts on this...???"
    MMM's investment in EXEL is not a factor for me. I actually prefer he not be overly vested in the PPS, as those biotech CEO's who own bundles of their own company can be perceived as overly biased and are frequently ridiculed by biotech analysts as selling junk science. While this board is often on a witch hunt for MMM, I don't see his lack of salesmanship or the poor visibility to his equity ownership as negatives. But I'm not a trader. I've always been way long here, with very little concern about MMM or the BOD managing short term PPS. If the science is good, which obviously I believe it is, the valuation will follow. Many of the decisions blasted by the YMB look pretty good in retrospect. The decision to raise cash last year before the interim was blasted on this board. If you go back and pull all the posts, there's a lot of angry posts. That decision as it turns out... genius. The convertibles may also turn out to be one of those decisions. That debt raising made METEOR and CELESTIAL possible. The timing appeared off and the pricing was strongly criticized, but there was risk in the MTC approval (which was uncovered later regarding OS data) that only MMM and BOD was aware of at that point. If MTC doesn't get approval, where would the PPS have gone? How would they have been able to raise the cash? The bottom line, I'm not a doctor or a scientist. I believe the decisions that have been made so far, were all done for the right reasons. The company will knock it out of the park with a strong showing in RCC. I don't think you would get much agreement from the medical community that the BOD and senior executives at EXEL are dicey. Rather quite the opposite.
    GLTA

    Sentiment: Strong Buy

  • duckduffer by duckduffer Mar 29, 2015 2:09 PM Flag

    Crashed into the earth and demolished EXEL's valuation, much has happened that might lead one to believe the short interest would be better served covering and moving on.
    *EXEL announces Roche filing of Cobi used in combo w/vemurafenib NDA
    *Meteor RCC Study enrollment completed in November/readout expected in Q2
    *ECOG/ACRIN Study E1512 in 2L or 3L EGFR wild-type NSCLC interim analysis meets primary endpoint
    *Roche Cobi NDA attains priority review/ August 11th PDUFA
    *Vemurafenib plus XL888 in malignant melanoma anti-tumor activity observed in 92% of evaluable patients
    *EXEL announces 2014 YE Cash of $242.8M sufficient to fund operations through year-end 2015
    *45 ongoing or planned studies of EXEL compounds with significant readouts in 2nd half of 2015
    *Comet 1 data release demonstrates greater than 50% OS improvement in CRPC patients with visceral mets
    None of these developments are negative. In fact, one would be hard pressed to find any negative developments for EXEL since the Comets. Pretty clear the short interest is hoping that METEOR doesn't hit endpoints. At this point...is that a bigger gamble than investing at these valuations on the long side? As mentioned by everyone ad nauseam..do your own due diligence...the YMB is a like looking through a landfill for treasures. Gotta sort through so much garbage...there are much better places to look.
    GLTA

    Sentiment: Strong Buy

  • duckduffer duckduffer Mar 26, 2015 2:02 PM Flag

    Window dressing has to be a factor here, with EXEL increasing for anyone who added in January around 50%. If you were a hedgie, who bought in Dec/Jan, wouldn't you take profits now? Your results for the quarter would be brilliant and you can always buy back in April before METEOR readout (probably) if you believe in the Cabo. At the same time for those looking to add shares, this might be the lowest PPS buying oppty before METEOR reads.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Been watching Exelixis for a long time

    by kahn_boonie Mar 24, 2015 1:26 PM
    duckduffer duckduffer Mar 24, 2015 7:54 PM Flag

    "I like your comment but I disagree that it would displace everolimus. It's a different target"
    Currently Axitinib has $410M in annual 2nd line RCC treatment sales as a VEGFR/KIT inhibitor. The median PFS of patients receiving Axitinib was 6.7 months in their clinical trial on previously treated patients in RCC. Cabo targets VEGFR/KIT/ and MET and is shooting for 7.5 months PFS in their clinical trial for previously treated patients in RCC.
    Whether it's taking share from Afinitor or Inlyta (axinitib), either or both will work for me. Cabosun, the trial vs Sutent is nearing enrollment completion and will read out in 2016.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Been watching Exelixis for a long time

    by kahn_boonie Mar 24, 2015 1:26 PM
    duckduffer duckduffer Mar 24, 2015 6:15 PM Flag

    "The question in my mind is not whether it will meet the 7.5 months median PFS, but how much more? 12 month or 14 month?"
    That really gets to the gist of how much increased valuation we might expect on a successful METEOR. If the Cabo PFS numbers match the earlier trial (12 months) and everolimus performs as expected (5 months), the valuation will be exponentially better than just meeting the trial endpoints. And considering how heavily pretreated the patients were in the earlier trial, who's to say Cabo won't outperform those results? With a 12 month PFS outcome, the assumption would have to be that Cabo will not only assume all of Afinitors (everolimus) marketshare in RCC ($400M per year), but that Cabo would also likely show better results than Sutent in that ongoing head to head trial. That would bring the possibility of Cabo being a $1B drug into the range of reality, and a foregone conclusion with a successful CELESTIAL trial in RCC.
    What is a $1B drug worth in market valuation these days? It's at least $5B. Oh yeah...what about Cobi...:)
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Rationale for Cabo plus immunotherapy

    by wilderguide Mar 18, 2015 11:59 AM
    duckduffer duckduffer Mar 18, 2015 1:31 PM Flag

    Perfect! Prom nite dumpster baby....one of my favorite "Family Guy" diddy's....worthy of a you tube break...thanks Wilder!!

    Sentiment: Strong Buy

  • Reply to

    New 8K-Deerfield

    by neers87 Mar 9, 2015 7:01 PM
    duckduffer duckduffer Mar 9, 2015 8:46 PM Flag

    They are not picking up $100M. They are exercising the option to extend the notes until 2018, as they discussed previously. This is nothing new.

    Sentiment: Strong Buy

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