"<<<Givens said the FDA "would be within its rights" to restart the clock, but refused to speculate on whether or not they would do so.>>>
Can Givens ever give a straight answer?
There sure are some good candidates for the ceo of the year in dufus we trust award. Lyons was bad, but Givens was worse."
You want Givens to start speaking for the FDA?!? Get real. I think what he said is technically correct, so what's your problem with that?
I'm as frustrated as anybody by the delays. But I have to wonder if MYOG/GILD will also run into problems with their upcoming filing. We may never know, but it may make sense for Givens not to help them by being overly transparent. That said, I do wish they'd gotten it right the first time. If, after acceptance of this upcoming resubmission as complete, the FDA decides it AGAIN needs to see more, then I think I'll give up, and I'll join in nominating him "for the ceo of the year in dufus we trust award." But I think Lyons was at least as bad in his handling of the Indiplon filing, and probably worse. He actually badmouthed the FDA after setting himself up for delay & failure by asking for a decision on both formulations at once. I think that's way worse than anything Givens has said or done. And that's before we get started on the electronic submission problem, far graver than this issue for ENCY. Or the lack of certain safety data (which, granted, could have been an issue here).
Nope, now that I review the events in my mind, Lyons is the clear winner of that award if I get to issue it.
Cheers, Tuck |
