Friday, September 04, 2020 9:32:27 AM
I figured early 2022 but the way the trial is designed it essentially added 6 months between the 90 day memantine free, one month break between cycles, and then 4 month observation at end of trial. The good news is if this does work, 42 weeks of safety data will be on the books with the FDA in moderately severe patients. They designed it to test the multiple cycle theory and to apply for approval if data holds up at week 28 while giving plenty of time on the back end to monitor test scores. In some ways the 4 month monitoring is set up as a win-win. If scores fall off, then it becomes more obvious the drug works but must be taken indefinitely. If scores don't fall off it stands to reason that synapses have been repaired and perhaps patients will cycle on and off the drug moving forward.
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