this is not CPR, this is a trial drug. Unless you are going to tell me you have examined the data from over 400 patients and can attest to their diversity, then don't guarantee the safety of something you have no experience with.
And while I'm here,
Yes, it is possible to have it both ways. You just won't have it 3 ways, and that is where the expert commentary on the other side fails.
Why not have 2,000 patients in a phase III trial, even if it is a great portion of the patients. In fact enroll as many as you can from the total population and let them know it is a drug trial.
One way is to have a phase III.
The second way is to get a possible treatment into the hands of as many of the afflicted as possible.
The third way, which you wouldn't have, is the money flow (or lack of it, really)during this .
I guess this is the cost-benefit analysis that also comes into play? The naive part is to ignore that small patient numbers will up the cost of the drug and a longer trial would worsen that? Part of this is about money?
And also the fact that the rest of you pseudo-FDA handicappers (myself included) are so sure this works and is fully safe is also drive by money.
And that is the stupid part, not the naive part. You'd rather arm chair quarterback this drug and push it out over having it go out under closely monitored and tested conditions simply because of money. The kids could have it both ways in my version of a phase III, but you wouldn't have your money. Are you willing to go there, or can you show (heh, inside info, anyone?) it's ready for production?