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Sanofi Message Board

scistats 64 posts  |  Last Activity: 3 hours ago Member since: Apr 5, 2009
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  • Reply to

    Dark humor to liven the mood.

    by scistats Oct 22, 2013 8:32 PM
    scistats scistats Jul 9, 2014 3:11 AM Flag

    Cool!

    Sentiment: Strong Buy

  • She certainly did a good job of poisoning America's innovative drug pipeline. People's heads are now on the chopping block and clinical trials will be shuttered in some cases. She did long-term strategic damage with a goal of moving money from one place to another. She has done long term damage to biotechs in the US. This is a historic set back.

    Sentiment: Strong Buy

  • scistats scistats Jul 17, 2014 3:01 PM Flag

    Biotechs are volatile and self correcting. A bad trial result, and we all know the consequences. What Yellen has done is strategically break the legs of the sector in a planned, strategic, targeted hit. And she can hit again. If this is coordinated, we can get hit in other ways. The money is on the move, the biotech lamb has been slaughtered.

    Sentiment: Strong Buy

  • scistats scistats Aug 6, 2014 3:36 PM Flag

    Interesting. Can you provide a source or link?

    Sentiment: Strong Buy

  • Who has the better techno, Mesoblast/Prochymal or Athersys/MultiStem?

    Can Athersys deliver more bang for the buck and undercut Mesoblast/Prochymal?

    How does Athersys navigate European exclusivity for stroke given to Mesoblast?

    With the potential at hand, why does Mesoblast have stroke on the back burner?

    "The granted patent covers the use of Mesoblast's allogeneic or 'off-the-shelf' MPCs for cardiac and vascular conditions, including acute myocardial infarction (AMI), congestive heart failure, angina, peripheral arterial disease, and cerebrovascular stroke."

    Sentiment: Strong Buy

  • Nearly three-quarters of all strokes occur in people over the age of 65.

    For the Athersys trial to be successful, MultiStem must achieve a Rankin Scale score of

    Sentiment: Strong Buy

  • scistats scistats Aug 9, 2014 5:01 PM Flag

    For the Athersys trial to be successful, MultiStem must achieve a Rankin Scale score of

    Sentiment: Strong Buy

  • Enrolling patients 18-65 years was a very bad idea. We have to deal with 25% wild card now.

    Sentiment: Strong Buy

  • Reply to

    Trial participants

    by scistats Aug 9, 2014 5:19 PM
    scistats scistats Aug 9, 2014 9:48 PM Flag

    Excellence_expected, my concern comes from the publication, 'Functional recovery after ischemic
    stroke - A matter of age, Data from the Austrian Stroke Unit Registry' where they clearly show that 'Odds ratios of a good functional outcome (modified Rankin score less than 2) at 90 days after stroke in different age groups' is vastly in favor of younger people.

    At 65 years of age and younger the odds ratio dives deeply toward achieving a Rankin score less than 2 with standard of care treatment (i.e. placebo can achieve this).

    These younger people represent 25% of our trial, and they do not need MultiStem to achieve our primary endpoint (Ranking of 2 or less). The placebo will achieve this with standard of care.

    If it was the objective of this study design was to show a difference between placebo and MultiStem by achieving a Rankin score of less than 2, then we would have been much better off only enrolling patients aged 66 and older (75% of stroke victims) and excluding those 65 and younger (25% of stroke victims) for a later day.

    The current study design may not achieve the primary outcome because we also have to deal with some older people (65+) who will respond better than expected and the fact that we are delivering IV which needs more patients to statistically prove success, i.e. more power. MultiStem may indeed work, but proving it with the inclusion of young people is going to be difficult. Stroke primarily affects 65+, Athersys should have stuck with this group. Now we have to data mine after removing 25% of an already small study group. I just hope they over enroll by at least double. They can still do this with more money.

    Sentiment: Strong Buy

  • 1. IV delivery as opposed to more direct delivery of the cells. Cells end up in lung, liver, and spleen. We have to hope that systemic inflammatory modulation from these sites is enough to inhibit damage at the actual site of the stroke.
    2. The inclusion of young patients who can achieve the Rankin endpoint of less than 2 using placebo alone at 90 days. These young people, less than 65 years of age, represent 25% of our patients, so our statistical power is reduced in a trial of already only 140 patients.
    3. The placebo plus standard of care may perform better than expected and be difficult to beat if the patients enrolled are otherwise healthy. In other words, standard of care could achieve a Rankin of 2 at 90 days.

    Therefore, this study may require a followup past 90 days to see a difference between placebo and Multi Stem. It may require removing younger patients, i.e. data mining to find significance. It may rely on sophisticated diagnostic imaging to visualize a difference. All of these do not constitute success as defined by the current endpoint. The only way to defend against all of these problems is to over-enroll to get our numbers up so that we can truly see what is happening.

    Sentiment: Strong Buy

  • Gil said enrollment slowed because of summer vacation and seasonal transition of med staff. I do not believe this to be the case.

    Stroke does not take summer vacation. Gil did, however, answer my question about how the trial handles patients who recover on their own. As he said, the trial is designed to select patients who do not recover over a few days. These are the more difficult cases, typically 75% of stroke patients on average because this is correlated with age, and 75% of strokes occur in patients aged 65+.

    25% of patients 65 and younger recover at a significantly higher rate (achieving a Ranking score of 2 or less at 90 days).

    I believe enrollment has slowed recently because, by random chance, more natural recovery young aged group patients attempted enrollment but failed to qualify. Enrollment should actually be accelerating because the rest of the UK sites recently came on-line as pointed out on this board but not mentioned by Gil.

    I believe Gil et al. realize that the 75% of patients 65+ who are enrolled are more challenging cases, and we know how MultiStem performed in challenging cases in the recent failed UC trial. Gil tried to draw an analogy of these older stroke victims with the animal model success, but what he failed to highlight was that the rodents were not geriatric with multiple underlying health conditions which may negate the efficacy of Multi Stem, especially given IV which is less effective than direct site administration.

    Multi Stem is up against a major challenge for no fault of its own, and enrolling more numbers is the only way to have a good chance of finding something significance. We have to deal with natural recovery primarily in young but also older patients, and those who cannot recover disproportionately have other confounding medical issues that impact Rankin. With IV rather than direct site administration, odds are this trial fails. Invest what you can lose.

    Sentiment: Strong Buy

  • Gil held up the Japan interaction as evidence of likely having stroke trial success.
    This is entirely unfounded. His highlighting of discussion with Japan were a tactic to make everyone believe this equates to a higher likelihood of a positive stroke trial outcome. Nothing could be father from the truth.

    Simply talking with the folks in Japan will not recover personal loses that occur due to a failed clinical trial. Invest with extreme caution here.

    Sentiment: Strong Buy

  • scistats scistats Aug 12, 2014 3:14 PM Flag

    Yes 66+ years of age is approaching the human lifespan of 78 years of age. Those having stroke are obviously on the wrong side of the bell curve. A certain % of patients will die with or without Multi Stem, you are right about this, and what is the modified Rankin score for death? It is 6. So, the way we get around issues like this is to enroll more patients. Otherwise a disproportionate number of deaths will kill the trial.

    Sentiment: Strong Buy

  • scistats scistats Aug 12, 2014 3:25 PM Flag

    Yes, but Gil failed to caution beyond safe harbor that talks with Japan have nothing to do with the success of an extremely risky trial that odds are will fail. I do not mind gambling or taking a risk, but people need to know that this trial is an extreme long shot. I am invested and long myself, but we all need to remind ourselves to invest only what we can lose here. Talks with Japan have nothing to do with success even though it was obviously intended to leave this impression.

    Sentiment: Strong Buy

  • scistats scistats Aug 12, 2014 3:30 PM Flag

    They can always say the Japan talks were for GvHD which Prochymal is already approved in Canada and New Zealand. This is how Gil and Athersys will C their A's in the event of a likely failed stroke trial. GvHD is the easy, proven fallback but with zero profit potential because of patients numbers. This is why Osiris sold Prochymal to Mesoblast. "We will not always succeed in what we do but rather succeed where others have already proven it most likely...GvHD."

    Sentiment: Strong Buy

  • scistats scistats Aug 12, 2014 7:54 PM Flag

    Excellence_Expected,

    IV administration is effective, but it is the LEAST effective, and therefore it can be tricky in terms of reaching the endpoint needed for success.

    In preclinical: "Effect sizes varied significantly with clinical measures such as administration route (intracerebral intra-arterial IV, although effect size for IV was nonetheless very large at 1.55) and species receiving MSCs (primate rat mouse)."

    So, yes, it may work, or because of the challenges of older human patients, IT MAY NOT.

    Source:
    Neurology. 2014 Apr 8;82(14):1277-86

    Sentiment: Strong Buy

  • scistats scistats Aug 12, 2014 7:55 PM Flag

    You know exactly what I am talking about in terms of Gil and Japan.
    I am long and see potential here, but he promoted Japan to promote the stroke trial. Period.

    Sentiment: Strong Buy

  • scistats scistats Aug 12, 2014 7:57 PM Flag

    What we have here is a risky gamble.
    Call a spade a spade.
    He touted Japan to tout the prospects of the stroke trial without discussing the high risk involved here. I am long and strong, but do not bet what you cannot afford to wake up and lose. Risk is being swept under the rug here.

    Sentiment: Strong Buy

  • scistats scistats Aug 12, 2014 8:20 PM Flag

    I think Gil is not stating the risk.
    Invest wisely. Gil can take care of himself.
    You need to invest only what you can lose.

    Sentiment: Strong Buy

  • scistats scistats Aug 12, 2014 8:39 PM Flag

    I am a strong buy within a prudent budget here. If you are correct, a little will go a very long way. I suppose you are estimating at least 100+++ PPS considering the potential of the market.

    Sentiment: Strong Buy

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