What safety concerns out of the normal concerns ??? Glad Mayo and rdgl are the experts Exactly so looks like no 4th 5th 6th 7th meeting needed. Rdgl gets the phase2 test completed bingo move directly to application and quick moonshot approval. Imo this is the direction the FDA rdgl and Mayo are going. One more time imo May approval
Doubt Mayo April practice has anything to do with making the ide submission any better for fda to approve. FDA isn’t approving Mayo competentece on the procedure rather fda is only concerned with rdgl ie the company submitting an application.
SC8, I can appreciate your objective views, but Mayo Clinic will not do "anything" for a fee. Hopefully you just meant that they rarely do anything for free.