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Tuesday, July 05, 2011 4:25:59 PM
But I think the delay lies mostly in that they have had to relearn how to approach the FDA.
The FDA is busted. Pure and simple. No body is going to argue with that.
It's sort of like that scene in Monte Python's Holy Grail where King Arthur and his knights are stopped by a crazy old sage on the top of a mountain who is blasting away at everything he sees with his lightning rod, destroying anything and everything for absolutely no reason. It's sensitive business trying to get a crazy old senile violent irresponsible wizard to let you pass.
I don't think that Dean will make his forecast of July 15th for the FDA meeting request. One thing it seems you can rely on from him is that he will overpromise and then miss deadlines and commitments. (3d Demo for example, still waiting) He doesn't even seem to know how many consultants are working for IMGG.
But all that said, I think they are close. JMHO.
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