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Re: McMagyar post# 74409

Sunday, 08/28/2016 11:02:22 PM

Sunday, August 28, 2016 11:02:22 PM

Post# of 459456
Yes, and remember the approved AD drugs only treat symptoms for the disease, and these drugs are estimated to be effective for treating some symptoms for 50% of AD patients. Think about that. Those approved drugs do not even treat all of the symptoms -- just some -- and they are effective for only 50% of AD patients in doing that.

So, why should we be upset that AVXL 2-73 may not be effective for 100% of the patients. Moreover, our patient population has been small for proving safety, and you cannot draw any definite conclusions about efficacy at this point. Thus, we need phase III to do that, and this phase must meet FDA approval.

We do have indications of efficacy. Hopefully, phase III will confirm efficacy to the satisfaction of the FDA. We do not need efficacy for 100% of the patient population -- just a significant number. For efficacy for FDA approval of AVXL 2-73, I believe all we need to show is improvement for a significant number of patients in our phase III over AD drugs the FDA has approved so far, assuming the FDA is true to its word that it wants to relax the standards for approval of AD drugs and speed up the process of approval with the caveat that it may require a phase IV post approval (post-marketing surveillance).
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