Friday, November 09, 2018 9:07:05 PM
https://clinicaltrials.gov/ProvidedDocs/68/NCT02431468/Prot_000.pdf
Which was CLEARLY long enough to best the current standard of care which fig 2a shows.
https://clinicaltrials.gov/ProvidedDocs/68/NCT02431468/Prot_000.pdf
That's the trial the company is using in regards of comparison with the FDA and the main reason the company feels confident with a p value of .012 in the non memantine population.
http://www.neurotrope.com/neurotrope-announces-the-initiation-of-enrollment-of-its-confirmatory-phase-2-trial-in-alzheimers-disease-copy-2/
Nobody has ever claimed it was a large number of non memantine patients but then again it doesn't have to be to show stat significance. 15 of 16 increased their test scores significantly. Next trial the FDA is good with two 50 patient arms. The beauty of this is you don't have to run large or lengthy trials in the severe population, especially when you have a couple thousand patients' safety profile records. Saves time and saves money and yields much cleaner results with less misdiagnosis.
Any competitors trial protocols or registrations to look at? Standard of care graphs or charts? Placebo comparisons? Statistical significance to look discern? I've seen some of what Biogen presented at CTAD. Anything else along those lines?
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