Thank for posting the numbers on patients over 70 BDZ.
So 469 patients over 70, of which 246 had MOCA scores below 25 indicating some cognitive impairment with 97 of those scoring below 22 indicating significant cognitive impairment.
So basically we have 246 people showing some degree of impairment, with roughly half that would be on drug and half on Placebo, so 123 in each arm.....allowing for dropouts let's say maybe 110 or so in each arm for this subgroup.
This has me wondering about the statistical significance of any data given the small number. I'm thinking it would be like trying to determine the outcome of a pending election based on a poll with a sample size of just 500 voters.
Do you think this is sufficient in size to warrant a Phase 3 trial or would a Phase 2 be needed? I'm not asking for a definitive answer, just opinion. I'm thinking this is where going for a Breakthrough Designation might come into play...allowing Apabetalone to be fast tracked because of the huge unmet need in AD and CD.