RE:the problem is that you have to be spot on65corvettesting wrote: with your protocol before you enter FDA because there is no turning back and its very costly. the time spent now is so valuable in so way ways. common sense. time lines will change. a basher is a person that always looks at the glass half empty. plus they likely get .10 cents/post=about 10 dollars a day or a hot dog and a pop. lol
This is probably one of yesterdays best insights. We've said it before but the legwork being done now by the best specialists in the field and doing it right the first time justifies delays. Enrollment will start by Q3 imo