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Oncolytics Biotech Inc. Message Board

  • rationalthought11 rationalthought11 Feb 2, 2013 3:10 PM Flag

    hello again

    I've carefully reread the press release of Dec.13 and, although it goes against my nature, rather than take a pass, I've convinced myself to throw a couple k play money at the Feb 2.5 puts for a dime on Monday if they don't announce results before I get around to it mid morning east coast time. At least 15-1 return if I'm right. Will rinse and repeat for March if no news. Every day delay skews the odds in my favor. If you want to see an analogy, take a look at Peregrine.

    "The first analysis compared the relative percentages of patients in the test and control arms with tumours that had either stabilized or exhibited shrinkage. For the purposes of this endpoint, the definition of tumour stabilization was restricted to zero percent growth only. Of the 105 total patients with evaluable metastatic tumours, 86 percent (n=50) of those in the test arm of the study exhibited tumour stabilization or shrinkage, compared with 67 percent of patients (n=55) in the control arm. This was statistically significant, with a p-value of 0.025.--

    What's not to like with the foregoing. Well for one they don't mention how many tumors "shrunk" and how many "stabilized" - Stabilized really means ( in the most cynical but truthful view) that nothing had been done to "cure" the disease, Normally companies tell you whether there was SD PR or CR ,if the data were good then you would hear about the CR's and PR's -- company was silent. This is bad news. As I posted earlier a 2 patient change one way or the other would have rendered the data statistically irrelevant.

    "The second analysis examined the magnitude of tumour response on a per patient basis using a comparison of percentage tumour shrinkage at six weeks in each patient with evaluable metastatic tumours. This analysis showed that REOLYSIN in combination with carboplatin and paclitaxel was statistically significantly better than carboplatin and paclitaxel alone at stabilizing or shrinking metastatic tumours, yielding a p-value of 0.03."

    What does this tell us? Once again it is important what wasn't said. Nothing about actual shrinkage of any kind-- Why avoid normal CR PR SD numbers? My guess few if any CR's and PR's

    "At the six week point, there is a numeric trend in favour of the test group towards differing activity between the test and control groups in patients with loco-regional tumours."-- This is complete spin. This means nothing more than FAILURE stated in a palatable fashion.

    "In an intragroup analysis of the test arm, an improvement in the percentage of patients' metastatic tumours over loco-regional tumours was noted (p=0.083) and an improvement of magnitude of response in metastatic tumours over loco-regional tumours was also noted (p=0.13)."-- The p values in the foregoing make this data almost criminally misleading to report.

    Last but certainly not least, these data came from site reads and not BICR reads. If you don't know what I'm talking about you should learn (quickly) or you will likely to learn the hard way. ALL reads are subjective and subject to error (which is reason enough to be worried about a two patient difference between stat sig and failure) but more importantly there is a very disturbing and documented trend in trials, where more favorable results are found from investigator site reads than from BICR reads. Given the fact that there is only a two patient difference between stat sig and failure and given that these were site reads, the trial is very likely to fail the PFS test when the results are subjected to BICR reads and may fail using only the current site reads.

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    • goodbye again

    • I am trying to figure out how you can use the term,"rational" in your nic. I have read your informationally twisted thoughts to spew your obvious agenda, but if anyone of intelligent nature reads your posts, I wonder how they can come up with an agreement with you about your thinking being rational. It just isn't. Now before you go and huff and puff and run for your ignore button because you cower from the truth, I will put you on ignore and laugh myself into a nice nap.
      What a blow hard you are!

      Sentiment: Strong Buy

      • 1 Reply to kenny94587
      • Instead of making an assssxss of yourself on yahoo message boards, a writing class at your local cc would be a better use of your time--Maybe start with an ESL class to give you a running stysrt to catch up your peers. To educated folks your posts just make you look like an idjit Sadly you already know you're of avg to below avg intelligence-- you've seen your test scores.

    • Well-placed hyphens.

    • Before I provide commentary on Rational's post, let me say that you may not think so, but as a biotech investor, detractors are your friend. You need them to present the weaknesses you may over look.

      That said, and without minimizing the very real risk that we all face as investors in any development stage biotech, I do believe that Rational has mistaken these two end points, as taken from the clinical trials site:

      Objective response (complete response (CR) + partial response (PR)) rate and duration [ Time Frame: Evaluation of response is conducted every 6 weeks on and after study. Duration of objective response is measured from the time measurement criteria are first met for CR or PR

      - And -

      Compare Best % Tumor Specific Response in loco-regional disease and/or metastatic disease for the treatment regimens in the study population.

      .
      My reading of the Dec 13 press release is that it was the Best Tumor Specific Response BTSR end point that achieved unequivocal statsig, and that the Objective Response OR end point was still a moving target. If my reading is correct, then Rational as conflated these two and does not understand that BTSR has succeeded.

      In doing DD on Rational's comments, I have not been able to find what BTSR really means and if it is a standard benchmark that carries much weight toward approval.

      I appreciate his comments because such opinions keep us grounded in out attempts to fit them into our own views.

      I personally have concluded that my risk reward profile is basically the opposite of Rational's at this point I have 5 Calls, Feb and March. I may go ahead and turn it into a straddle by picking up some 2.50 Puts as well.

      Reading Rational's points have given me pause and a re-appreciation of the risks, and I realize I have tended toward cheerleading of late.

      A lot of you guys have real money in this. Money you probably can't lose.

      Consider protective puts or closing long positions for small stake options with comparable upside but much better controlled losses.

      Be freaking careful.

      • 3 Replies to hgff101
      • People who have closed their minds to any thesis are fools and their beliefs lack rigor. You are aware of this. I continue to go over the data because there is a trade here. I reiterate for you that a change in just 2 patients in either the control arm or the treatment arm in mets would have rendered the results statistically insignificant. This is just math. Add in the fact all image reads are subjective albeit they could err in either direction and it is a coin flip at best as such the "new" mets arm trial is hanging by a thread. When you add in the fact that the loco regional treatment group failed it reach statsig, it is almost a certainty that the trial taken as a whole, failed to reach statsig at first read. There seem to be a few people here with large positions. Let's hope they can afford it.

      • hgff101, you said, "My reading of the Dec 13 press release is that it was the Best Tumor Specific Response BTSR end point that achieved unequivocal statsig, and that the Objective Response OR end point was still a moving target."

        I think you are mistaken as regards the Best Tumor Specific Response. The Dec 13 results do not give the Best Tumor Specific Response. The best % tumor specific response is the greatest % shrinkage recorded from the start of treatment until the tumor starts growing again. What was released in the Dec 13 results was the tumor specific response as of the 6 week scan. These results were already statistically significant, but the BEST is yet to come. Past experience has shown that with REOLYSIN in many cases tumor shrinkage continues long after 6 weeks (Brad mentioned that shrinkage sometimes continues for 6, 7, 8, 9 months). And how many scans have we seen in investor presentations, particularly with metastatis lesions, where tumor shrinkage has continued over many treatment cycles. So as impressive as the 6 week tumor shrinkage is the best tumor specific response will be greater. And what is already impressively statistically significant will become much more statistically significant with time.

        I think we need to be freaking careful that the shoddy arguments of ill intentioned detractors don't obscure the facts.

      • "Be freaking careful." Could not have said it better! The data to date has been "underwhelming", delayed and painfully slow. All investors in this company may be in for a shock that could be somewhat good or very bad. That said, I continue to increase my position with money that would otherwise have gone towards other types of lottery tickets - the odds here are better.

        Sentiment: Buy

    • Well let me start by saying I'm not educated in medical studies, but I can do a little research. I found a slide presentation on BICR (appears to pitch the importance of BICR in PFS studies) and in the conclusion slides a main point is "may not be required for double blinded studies". Which makes me feel alittle better since ours is double blinded.

      He sure made his argument sound good to an untrained ear like mine.

      pjc

      • 1 Reply to pjc_af92
      • " Which makes me feel alittle better since ours is double blinded."

        This evaluation of randomized double blinded studies vs a (biased) BICR should make you feel even better!

        Search: Blinded Independent Central Review of Progression-Free Survival in Phase III Clinical Trials: Important Design Element or Unnecessary Expense?

        J Clin Oncol. 2008 August 1; 26(22): 3791–3796.

        "Randomized clinical trials are the gold standard for shaping clinical practice by providing definitive evaluation of treatment efficacy. "

        " We argue that, while blinding is a generally desirable means of reducing potential bias, BICR may itself introduce bias into treatment efficacy estimation.

        Once again irrational_thought (aka Paul Springer/hasbeen) doesn't know what he is chirping about.

    • "What's not to like with the foregoing. Well for one they don't mention how many tumors "shrunk" and how many "stabilized" - Stabilized really means ( in the most cynical but truthful view) that nothing had been done to "cure" the disease, Normally companies tell you whether there was SD PR or CR ,if the data were good then you would hear about the CR's and PR's -- company was silent"

      The company was not silent, they spelled it out in the waterfall chart in the investor presentation where you can see in the test (Reo) group:
      about 14% had growth in tumor, about 8% had stable tumor and the rest about 78% had tumor shrinkage with about 50% having tumor shrinkage between 20% and the test max of 80%.
      whereas in the control group:
      about 30% had growth in tumor, about 8% had stable tumor and the rest about 60% had tumor shrinkage with only about 35% having tumor shrinkage between 20% and the control max of 50%.

      Those are significant, meaningful differences that bode well for potential neo-adjuvant approval.

      To put it another way for the test group the breakdown of the 86% is 8% stable and 78% tumor shrinkage. Since n=50 for the test group you can deduce the following: 4 had stable tumors and 39 had tumor shrinkage (the remaining 14% n=7 had increases in their tumor size).

      • 1 Reply to taltell
      • Nicely put. One (fairly obvious) thing you didn't mention:

        "normally companies tell you whether there was SD, PR or CR....". The man is apples vs oranges confused. A "normal" SD is tumor growth up to 25%. In our report (neo adjuvant criteria) "stable" was defined as ZERO growth. A vast and important difference.

    • Why not just dona strangle? Cover both sides as the move will large.

    • " This analysis showed that REOLYSIN in combination with carboplatin and paclitaxel was statistically significantly better than carboplatin and paclitaxel alone at stabilizing or shrinking metastatic tumours"

      What this analysis shows is that REOLYSIN is demonstrating to be the statistical reason why metastatic tumors shrunk or stabilized compared to carboplatin and paclitaxel.

      "At the six week point, there is a numeric trend in favour of the test group towards differing activity between the test and control groups in patients with loco-regional tumours."

      This statement suggests the trend is towards statistical signifiance in favor of REOLYSIN and that the trend should improve with increased time.

      The rest of irrational_thought's (hasbeen's) ramblings do not require any further response.

      • 1 Reply to carrivechio
      • "At the six week point, there is a numeric trend in favour of the test group towards differing activity between the test and control groups in patients with loco-regional tumours."

        "This statement suggests the trend is towards statistical signifiance in favor of REOLYSIN and that the trend should improve with increased time."

        It says nothing of the sort, but hey whatever gets you through the night. I'll defend to the death, your right to be misinformed.

 
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