Saturday, September 07, 2019 7:57:58 PM
Why wouldn't you run it again? You think the FDA doesn't want to know for sure if memantine patients indeed need to stop taking memantine to get the synaptic effect before telling a couple million patients to NOT TAKE memantine if bryostatin is approved for this population? Talk about missing the forest for the trees. Would I rather trade a 1 year trial that cost 10 million dollars followed by a pivotal P3 run on a larger number without memantine or would I rather run a 30 million dollar trial and hope those 16 memantine patients told the tale, and then have to run an additional P3 most likely. We'll now have 250 patients ran between our two trials and less than 20 million dollars into them. If successful we'll likely be running a pivotal P3 before applying for an NDA. I know which I would rather run.
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