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VirnetX Holding Corp Message Board

duckduffer 41 posts  |  Last Activity: Jan 28, 2015 10:58 AM Member since: May 29, 2003
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  • Reply to

    Short interest drops less than 1%.

    by enabeler Jan 28, 2015 9:36 AM
    duckduffer duckduffer Jan 28, 2015 10:58 AM Flag

    FDA will make a decision on Priority Review for Cobi, best estimate is by Feb. 13th or 16th. That should give the PPS a little boost if granted. Will shave months off the approval time. The announcement for FDA submission was Dec.14th, FDA has 60 days to grant or deny Priority Review. Considering the combo extends PFS by 50% it would seem like a no brainer for Priority Review approval.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    13G Wellington buys over 1mil shares

    by ckcm25 Jan 12, 2015 3:21 PM
    duckduffer duckduffer Jan 20, 2015 5:46 PM Flag

    Just so this thread can cease, it is a fact that Wellington sold the majority of their EXEL holdings and no longer hold in excess of 5%. They began selling after the Comet 1 Interim March 26th. Took them 8 months, but it looks like they are almost completely out of their position. This 13G was not a buy. This was a notification of a further reduction in holdings to well below 5% (.64%).
    This isn't exactly big news considering they have been exiting the position since March.
    GLTA

    Sentiment: Strong Buy

  • duckduffer duckduffer Jan 19, 2015 1:56 PM Flag

    While I would agree we will learn more about the trials detailed results, I disagree on the inference that the approval of Xtandi and Xofigo are the confounding factors in the trial outcome. Xtandi due to the Comet trial design that required prior treatment with either Xtandi or Zytiga. That factor would limit the effectiveness of follow on treatment with either drug. And Xofigo due to the requirement that the patients eligible for Xofigo not have visceral mets. That should have limited the patient pool who could have gone on Xofigo after dropping out of the control treatment.
    There may be other PC drugs that confounded Comet results, Jevtana for example, but those would have been well within the sights of the trial designers.
    Instead of looking for the smoking gun of confounding factors, I'm more inclined to believe Cabo's place in PC treatment is within a very specific subset of patients, not the general population of patients. And that is why Comet was a fail. We know the drug has efficacy, but very much like in MTC, it likely works quite well for some mutations and with very little or zero efficacy in others.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Has anyone even noticed...

    by wilderguide Jan 15, 2015 12:15 PM
    duckduffer duckduffer Jan 15, 2015 1:43 PM Flag

    He was part of the cost cutting measures right after Comet 1 readout. I saw the 8K and didn't think twice about it. It aligns with the need to reduce expense and he was probably sitting on his hands for the last couple years. What else would he have been doing? EXEL outsources the current sales force. They can easily add Cobi to that group for their 25% comarketing opportunity after FDA approval in MM. In addition, after a positive Meteor readout, they will have plenty of time to staff up the sales organization prior to an FDA approval of Cabo in RCC. No point paying a guy you won't really need for another year.

    Sentiment: Strong Buy

  • Reply to

    48M shares shorted

    by godhairyballs Jan 8, 2015 10:52 AM
    duckduffer duckduffer Jan 8, 2015 4:12 PM Flag

    What is your point? That instead of covering a short position, a convertible holder or institutional hedge will choose to use an options strategy? So all 48M short shares will never be covered?
    There is no doubt that trading strategies such as you have described have been used to trade EXEL in the past. But as we approach another binary event, manipulation becomes more risky. Don't expect to see the blatantly obvious trading ranges being orchestrated like the 2 years prior to Comet. We are rapidly approaching topline data for Meteor. See what happened last year prior to the Comet interim results to get an idea. PPS went from the low $4's to as high as over $8. History would suggest the PPS here will continue to increase as well until we get a Meteor readout. A billion dollar valuation prior to the readout would not shock me. Doesn't mean all the short positions will get covered, they didn't last year. But to suggest the entire short position is an arbitrage short is misguided.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    48M shares shorted

    by godhairyballs Jan 8, 2015 10:52 AM
    duckduffer duckduffer Jan 8, 2015 12:54 PM Flag

    "48M short are arbitrage short never to be covered "

    That statement seems improbable at best. There were 34.5M convertibles issued in 2012. Even if you suggested that every single convertible is being arbitrage shorted....that still doesn't account for the total current short interest of 48M shares. Plus the arbitragers are in this to make money off those shorts when the opportunity presents itself. I.E. they will cover those shorts at a profit when it appears the PPS is going to move north. They will cover and then short at a higher price. We've seen it here since 2012.
    The other anti short squeeze argument is that many shares are institutions hedging their long holdings with short positions. The same logic applies. If the PPS is showing signs of moving north, they also are in this to make money. Cover and then short again at a higher price.

    GLTA

    Sentiment: Strong Buy

  • Reply to

    Form 4

    by najarian_t Jan 6, 2015 10:04 AM
    duckduffer duckduffer Jan 6, 2015 11:31 AM Flag

    "I find that hard to believe"

    Then keep your eyes peeled on the SEC filings. Seeing is believing.

    Sentiment: Strong Buy

  • duckduffer by duckduffer Dec 31, 2014 2:14 PM Flag

    This stock has the potential to be one of the best performers in the NASDQ next year. Results will mean everything.
    Catalysts-
    *Priority Review granted for Cobi
    *EGFR wild type lung cancer Phase 2 trial data presented for Cabo
    *Meteor Phase 3 RCC trial top line data
    *Launch of Phase 1b Triple-combination Trial of XL888, Vemurafenib, and Cobimetinib
    *Updates on Roche trials with Cobi and anti PDL1
    *Updates on other NCI Cabo Phase 2 trials
    *Cobi FDA approval
    *Cobi/Vemurafenib European Approval
    *Rapid Cobi/Vemurafenib adoption, strong early revenues from BRAFV600 MM

    Here's to better patient outcomes, better trial results, and better PPS performance in the New Year!

    GLTA

    Sentiment: Strong Buy

  • duckduffer duckduffer Dec 29, 2014 12:11 PM Flag

    "it's not hard to see the company valued at $500 million, double where it is now"

    It's funny how a double sounds so ridiculously low. Tells you how far this has fallen. If Meteor reads out anywhere close to the early trial results, with a PFS of 14.7 months, a quadruple would even sound too low. From here a quad is still only a market cap of $1B. EXEL had a market cap of $1.7B last January prior to the interim read out for Comet. The comparator arm of Meteor is Afinitor, a drug with sales of over $1B annually of which over $400M are attributed to RCC treatment. If Cabo improves PFS by 50% or more, which is the goal of the trial, it's easy to conclude Cabo takes the majority of Afinitor patients away. A $400M annual opportunity. That equates to much more than a $1B valuation for EXEL.
    GLTA

    Sentiment: Strong Buy

  • duckduffer duckduffer Dec 19, 2014 1:30 PM Flag

    If the odds were greater than 50%, the PPS would be much higher. The most caution for Meteor should be around the small trial size of the Phase 2. Not whether it works. It works in RCC. We just don't know if the patient subset is exactly right due to the small sample size. Having said that, my opinion is very similar. Comet was a much bigger gamble than Meteor. The RCC data is easy to interpret. In a small trial the PFS was exceptional. If that translates we have a hit. The mCRPC data, as MMM said frequently, was very provocative. But...there wasn't definitive Cabo OS data for mCRPC when the Comet trials were designed. Only supporting evidence like good PFS, bone scan responses, pain palliation, and lower CTC's. But no definitive proof. Cabo probably does support OS in several patient subsets. But the trial was designed based on a somewhat limited understanding of who would benefit enough to make it successful.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Smart Money

    by jvictorn00 Dec 17, 2014 10:02 AM
    duckduffer duckduffer Dec 18, 2014 3:13 PM Flag

    "The cobi NDA filing was the last potential catalyst we're going to get here for a while"
    The next most obvious catalyst would be a Priority Review for the NDA from the FDA. That will either happen or not within the next 60 days. The significance is it relates to how quickly EXEL will be getting revenue for Cobi in BRAFV600 MM. There is also the possibility of more data on the wild type NSCLC trial that achieved stat sig trial endpoints at the interim which was announced on Nov 4th . That could be meaningful as it's a big indication and could lay the groundwork for a partnership (cash plus development) in that indication. There is also the possibility of data from some of the other 2012 IST Phase 2 trials popping up (just like the wild type NSCLC). Perhaps some early data from the Roche Cobi- PDL1 trials as well. I would agree there is probably going to be selling all the way up to year end for tax purposes, but come January we might see accumulation overcome selling pressures.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    From the Roche news release

    by enabeler Dec 15, 2014 7:56 AM
    duckduffer duckduffer Dec 15, 2014 6:51 PM Flag

    Another thing to consider in your $300M sales projection for Cobi combo, besides use in other indications, is the length of time patients will be on the drug. Since PFS is 50% longer on the Combo, than on Zelboraf alone, it would imply an increase in usage overall of 50% just due to time on medication. Perhaps a $400M+ projection, based on duration of treatment alone?

    Sentiment: Strong Buy

  • Reply to

    From the Roche news release

    by enabeler Dec 15, 2014 7:56 AM
    duckduffer duckduffer Dec 15, 2014 1:48 PM Flag

    I'm wondering if the next significant news item will be regarding priority review. They received a Fast Track designation for Cobi so you would have to believe they are requesting a Priority Review with this NDA. If so, it would come within the next 60 days. If issued, it would guarantee a 6 month or less action on the NDA vs the standard of 10 months.
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Look for end of year PR about coBRIM filing

    by patriot901 Dec 12, 2014 11:16 AM
    duckduffer duckduffer Dec 12, 2014 3:56 PM Flag

    " The FDA already knows this is coming and the results from trials were very positive".
    Easiest decision they will ever make. Cobimetinib plus Zelboraf reduced the risk of disease worsening by half ( median PFS 9.9 months vs 6.2) compared to Zelboraf alone. The IRC had even better numbers, with CobiZ median PFS of 11.1 months vs. 6.0 for Zel alone. This will not only fly through the FDA Fasttrak approval process, it will be adopted by healthcare professionals even faster. Why would you even consider using Zelboraf alone?

    Sentiment: Strong Buy

  • Reply to

    Comet-1 vs. Meteor

    by ulingt Dec 9, 2014 8:29 PM
    duckduffer duckduffer Dec 10, 2014 12:58 PM Flag

    MM made these comments during the Stifel CC in November. At around 14:30 into the call he said-
    "Both VEGF and MET play a part in RCC. This was the initial rational for combining these two inhibitory activities into a single molecule.....we used the RCC tumor biology to base our initial hypothesis for the design of molecules like Cabozantinib"
    I'm paraphrasing slightly but you can go back to the conf and listen for yourself.
    As for the logic behind why/if PFS improvement in Comet 1 is significant relating to Meteor, it probably isn't. Two different types of cancer. But many have suggested that Comet 1 was a negative indicator for Meteor, which couldn't be further from the truth.
    For a better indicator of what might happen in Meteor look at the Phase 1b trial data. Small trial, but in a cohort of heavily pretreated patients, PFS was 14.7 months. Compare that to the primary endpoint for Meteor of 7.5 months PFS. Small studies for obvious reasons don't always demonstrate consistent results with larger studies. But if the Phase 3 trial was a sure thing....the PPS wouldn't be where it is :)
    GLTA

    Sentiment: Strong Buy

  • Reply to

    Yet another question...or maybe an observation

    by ulingt Dec 8, 2014 8:37 PM
    duckduffer duckduffer Dec 9, 2014 7:49 PM Flag

    Also, I referenced liver cancer. I meant RCC, which is kidney cancer. Long day. Cabo was designed to treat kidney cancer.

    Sentiment: Strong Buy

  • Reply to

    Yet another question...or maybe an observation

    by ulingt Dec 8, 2014 8:37 PM
    duckduffer duckduffer Dec 9, 2014 7:14 PM Flag

    "can you explain the difference between ' PFS topline and stat sig positive PFS'?"
    Sorry, that was a bit of a hurried post. PFS is the primary endpoint in Meteor. It means if they achieve the topline results for the primary endpoint, it would suggest they would be able to get FDA approval. PFS was not a primary endpoint in the Comet 1 trial, however, it was an exploratory endpoint. And in the exploratory endpoint of PFS for Comet 1 the data was stat sig or statistically significant. Since PFS is not an approvable endpoint in mCRPC, it didn't matter that PFS had a statistically significant improvement over the comparison arm.
    "how is it determined where to set the bar?"
    The bar is based on demonstrating a statistically significant improvement over the comparison arm of the trial. In Comet 1 it was the prednisone arm. In Meteor it is the everolimus/afinitor arm.

    Sentiment: Strong Buy

  • Reply to

    Yet another question...or maybe an observation

    by ulingt Dec 8, 2014 8:37 PM
    duckduffer duckduffer Dec 9, 2014 2:23 PM Flag

    Last post was cutoff. The PFS from Comet 1 was a 50% improvement over the prednisone arm (5.8 mo vs 2.8 mo). The primary endpoint for Meteor is also a 50% improvement. This data from Comet 1 thus supports a successful Meteor. Quite the opposite from what many bears are posting.
    Beyond the Comet data, the development of Cabo was based on the theory that inhibiting both VEGFR and MET might be key in successfully treating liver cancer (per MMM on the last CC). Cabo, while active in many cancer types, was specifically designed for liver cancer. Logic dictates with a PFS endpoint in and indication the drug was designed to treat the odds are much more favorable for success in Meteor.

    Sentiment: Strong Buy

  • Reply to

    Yet another question...or maybe an observation

    by ulingt Dec 8, 2014 8:37 PM
    duckduffer duckduffer Dec 9, 2014 12:59 PM Flag

    Some are projecting a fail in Meteor due to the Comet topline. Not logical. Meteor has a PFS topline. Cabozantinib had stat sig positive PFS in the Comet 1 trial. Median PFS was 5.5 months for the cabozantinib arm of the trial versus 2.8 months for the prednisone arm (hazard ratio 0.50; 95% confidence interval 0.42 – 0.60; p value

    Sentiment: Strong Buy

  • Reply to

    wilder, ernie, duckduffer, etc.

    by enabeler Dec 2, 2014 2:41 PM
    duckduffer duckduffer Dec 3, 2014 8:13 PM Flag

    They had $293M in cash at the end of Q3. You might be a little off on your prediction.

    Sentiment: Strong Buy

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