Thanks Toke!..Avoidance of interim efficacy number...Will need to be solved before anymore of these said "partners" dip their pen in Spectral's ink.
Yeah, I'm afraid even a 15k spend for a Glass opinion will not suffice this go round
I see Bioniche / Telesta has received the thumbs up from Glass for their Quebec foray
Interim data suggested 11-12% absolute efficacy.....
The original trial was for 360 patients to show a 15% absolute benefit.
At the interim data point ( 184 patients ), the DSMB/Spectral/FDA all agreed to an adjustment moving the patient count to 650. The required number was 600, but 650 was the chosen amount to adequately power and complete trial. This trial size suggests expectation / requirement of an eventual 11- 12% absolute efficacy.
We know that 720 patients and the corresponding 10% absolute benefit was set as the minimum level of efficacy for the trial.
How is it that an 11 - 12% absolute benefit demonstrated at the interim data point has been swept under the rug?
Sqr
PS - GO JAYS GO!