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Re: kld2 post# 17633

Wednesday, 09/09/2015 9:09:23 AM

Wednesday, September 09, 2015 9:09:23 AM

Post# of 461234
I believe that what George may be surmising (as LJ suggests) is that the AVXL study may have been designed by Anavex to begin as a randomized study and later all participants may have been switched to actually taking the drug, meaning some were on a placebo and later switched to taking the real thing. The FDA Guidelines would allow this, and Missling presumably fully understood that the FDA Guidelines allow that. Therefore, none of the participants may now be on a placebo. If some participants started out on a placebo, were later switched to the real drug, and they lag behind the others that were always administered the real drug, the FDA would be very impressed and may more quickly approve this drug. Also, if such a study ends successfully, it would be the first instance where this type of design succeeds.
If Missling designed the study as has been suggested, it may be considered a bold move and/or that Missling is absolutely confident the drug works.
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