Is Spectral choosing to play the "exact words games"?We know this ended badly for Greg Brady when Mike and Carol let him "play the game".
Note that fact that..."for this sample size" was used twice in the news release..
What about "other sample sizes"?
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!