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chumppunk

02/15/17 12:41 PM

#10675 RE: The Lawman #10674

Lawman- I disagree because there is far more results than just evaluating these 10 patients that has been accomplished but I repect your thoughts. You don't get access to BTD, Fast Track, Orphan etc. without more.
Chump

pearsby09

02/15/17 12:51 PM

#10677 RE: The Lawman #10674

I totally agree Lawman. We need a well designed, multi-centered, double blind vs.(control group) trial to make heads turn from the overall market. That being said, the FDA has endorsed a N=30 trial for adjunct..which honestly is quite small..but we will take it. Small "N"'s are great for enhanced expeditious enrollment, however, the small sample size can work against you as well as for you. Say you get 10 bad selection candidates..just by chance. There goes your data...uugh. OR, you are lucky and you get 25 perfect PRO 140 candidates that are potentially high rate respondents...Boom. Especially with a P value equal/less than .05 minimum. (P=.05) is usually standard probability ratio. "N" can be subjected to stronger P values.

pearsby09

02/15/17 12:54 PM

#10678 RE: The Lawman #10674

Lawman, on another note. It really doesn't matter what the overall market thinks..it is what BP thinks.... CYDY will never market/commercialize this drug.. no matter what the results! This is 100% BO necessitated!!

Saltz

02/15/17 1:09 PM

#10682 RE: The Lawman #10674

BTD is the precursor to the clinical trial results that will yes move the needle. BTD will change the way the POSITIVE results will be viewed. BTD is the FDA's way of saying we like what you have so let's get it to market fast.