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Re: Whatsupp post# 11137

Tuesday, 06/04/2019 4:07:16 PM

Tuesday, June 04, 2019 4:07:16 PM

Post# of 21540
Cyosol brought this up the other day. Its not really 3 new outcome measures though. They are clarifying the measurements at week 13. First keep in mind that primary outcome endpoint is week 13 as it was last go around. The 30 day follow up from from final dose at day 77 is the week 15 score which is a secondary measure to see how the synaptic regrowth MOA is playing out. What the FDA is in agreement on (or asked for) is changing the way the week 13 was scored from the average of week 13 and 15 which was investigated with the last trial due to the small non-memantine number that skewed results if any patient was missing. There is a way to deal with that and it was discussed in the trial protocols. Now we'll get a true week 13 score and a true week 15 score, and numbers of completing patients should be adequate for this. In reality due to the small N in the trial, without the "average" we were stat significant at week 13 but the averaging method made it even more so. Probably hurt our week 15 delta because it had a few week 13 scores average in. Now we'll get to see both.
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