Damn - I hate to see the endless scrutiny of these products. I advocate less regulation. I’ll assume the risks associated. I’ll sign something saying I won’t sue. I’d like faster development of drugs and medical products.
Without any access to the questions or the data which was already submitted, I can only guess at the “issues”. But the GEN-4 Sensor wire is less prone to breakage than the current wire is, so I would hope that the FDA has good reasons to leave us at MORE risk with this problem.
But I’ll SWAG that the real reason is probably Avandia, and FDA’s diabetes analysts are all terrified of “allowing another mistake to come on the Market”. FDA doesn’t get blamed for people dying from inadequate current treatments which are recognized as “safe”; so it’s safer for their careers to put everything on hold for a while, demanding “almost total certainty”.
It’s only a guess, I could be wrong. I hope so. But if I’m RIGHT, then I hope that FDA’s Avandia-induced hysteria clears up quickly. It’s killing us.