Re: O'Brien-Fleming spendinf function
I know that many here won't recognize what the FDA and other regulators have, there are decades of data from trials and historical patient data that say how deadly GBM is, no new treatment has been approved in about 18 years, so yes, the trial can be run without a control group, at least when evaluating Overall Survival.
There is no way I can prove it to you, or vice versa, other than regulatory approvals or rejections, I believe that it will be happening in the next year, and yes, the FDA will approve, and I'd not be surprised if they weren't the last to approve. I do expect the UK to be first, but beyond that the company has provided no guidance.
I still believe the acceptance of the EDEN unit is the key to adequate commercial production, but I don't know that the regulators will insist on that as long as they're satisfied with manual methods, which the UK has already approved.
I'd be willing to bet that in the next decade, most newly designed trials for terminal diseases will be done without control groups and all the regulators will accept them.