Here's a controversial thought that very few here
Post# of 148171
With the shocking acceleration in enrollment in both trials seen in the past two weeks, why not just push back the cut-off date for both by a week or so.
I can't tell you how many posts I've read on multiple message boards expressing deep concern that the power of our trials may not be sufficient for approval.
I'd rather delay the cut-off for both trials by a week or so, and maybe get both of them closer to 100 subjects -- than be forced to do a P3 for the M/M, and be forced to finish the 390 subjects for the P3 S/C.
And I say this from both a "saving lives" point-of-view, as well as SP point-of-view.
Lastly, let me just add that I have reviewed the P3 S/C protocol several times and would appreciate someone showing me specifically where it mentions an interim look at the first 50 patients. I have never been able to find it. And, so if it's not really specified, then it isn't the driver for stopping the enrollment of the P2 M/M.