Is the scheme you describe a risk? Sure. Any new mechanism is, until it has a track record. What I meant by legible: to run it, you'd have to pass FDA's IND re

Is the scheme you describe a risk? Sure. Any new mechanism is, until it has a track record. What I meant by legible: to run it, you'd have to pass FDA's IND review and reporting requirements, IRB review of the Phase 1, and then Montana ETRB review, with public annual outcome reporting and no withholding of safety data from patients. That's a high bar. If your view is that nothing short of full approval is enough of a bar and no alternative should be tried even at small scale, fine. We should agree to disagree here then.