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Admiral38

05/19/10 4:08 PM

#16211 RE: IMGGorBust #16203

Does anyone have the foggiest notion of what the FDA's internal guidelines are? Or is this an urban legend that they have guidelines in the first place? Why can't we get a straight answer? Does Dean have a clue as to what their guidelines, if any, really are? I am getting a bad feeling about this for the first time.
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prussian4profit

05/19/10 4:19 PM

#16213 RE: IMGGorBust #16203

IMGGorBust,

Regrettabley, the FDA can "restart the clock" if they deem it necessary. Regardless of fast track or not, FDA has the right to say they need to re-review in lieu of new info that is brought forward due to fast track communications.
I would hope and expect Dean and Co. to make an announcement if this were the case.

Bottom line, the FDA can take longer than 90 days if needed.

This is why I keep saying that this is a FDA, period. When they say yay or nay is when things will become interesting. Until that time, we are going to see manipulation at it's finest. It's a shame that's how the game is played.

There is no countdown clock, just ignition or explosion.


-p4p