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Biogen, Anavex, PBT, page-10

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    I posted scientific critique and printed quotes from notable scientists in the field. Dr. Tanzi is being publicly diplomatic. Of course you have cherry picked - here's what else Tanzi said:

    Tanzi review of Biogen data
    "While the new Biogen therapy shows great promise as it heads directly into a much larger Phase III “efficacy” trial, there are also some concerns, Tanzi noted. “While we are very excited and optimistic about the new Biogen therapy, there is still a lot of work yet to be completed and we cannot just assume that the next trial (Phase III) will be a slam dunk."
    First, the significant cognitive results using the specific memory tests that the FDA bases approval upon, came only from the highest dose group. There were 32 patients in this group versus 40 patients on placebo. “These are still small numbers,” Tanzi said. “so, while we are very hopeful, is not guaranteed that the results will be replicated in the larger Phase III trial."
    Second, the placebo group had a larger decline in cognition over one year than has normally been observed in trials in the past. This may have contributed to a relatively large difference in cognitive decline between the placebo group and the high-dose group. If, in larger trials, the placebo group declines more slowly, it is not guaranteed the treatment groups will attain statistical significance for slowing down cognitive decline.
    Third, there were some side effects, most notably brain swelling and headaches. “These side effects generally resolve on their own over time,” said Tanzi, “but they are a potential concern since they could lead to drop out of patients from future trials”. The side effects were most prevalent in the highest dose group and in carriers of the APOE4 risk gene (present in 60-70% of Alzheimer’s patients)."
    See rest on curealzDOTorg/2015/03/promising-new-alzheimer’s-drug-validates-anti-amyloid-approach

    and CH from ymb reply to me:
    anadianhegemony • Jul 18, 2015 11:59 AM Flag
    8users liked this postsusers disliked this posts1Reply
    Tanzi's trying to be polite and statesmanlike. We all know Biogen's decision to go into a p3 is all about stock pumping and not science. With the level of severe side effects and the abnormal placebo decline in cognition, the right scientific approach would be to run a confirmatory p2. (...but at least the side effects were dose-dependent! ...does that prove "target engagement"?)
    The other right thing to do would be publish the data. And no, a stock pumping PowerPoint doesn't count. Peer-reviewed paper, full data set. Let's run those numbers again versus a normal rate of placebo decline, shall we?

    You twist and turn words and post nothing of value in a scientific manner only bashing. Try again. Be specific about where my analysis is wrong. Specifics. By the way PBT2 is an ionophore, therefore it is not reliant on the amyloid hypothesis for validity. You have your facts wrong again.
 
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