News Focus
News Focus
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fidder05

09/14/10 5:24 PM

#26641 RE: BuyMyAsk #26639

Great post on this full situation at IMGG.
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ysung

09/14/10 5:24 PM

#26642 RE: BuyMyAsk #26639

You are very frustrated just like many of us.

I wonder if dean is playing ping pong
with FDA for more questions and we
just don't know about it.

What else could it be ??
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IMGGorBust

09/14/10 5:29 PM

#26643 RE: BuyMyAsk #26639

I understand your frustration, but you are talking like the FDA breezes through other applications, yet here ours sits as an outlier in how long the FDA has taken. We are in the same boat as every other applicant. Was there something wrong with the devices for the thousands of other applications that took approx. 150 days - 160? If we get out past 185 or so, then it's at least fair to say that we're getting jerked around by the FDA in a manner unlike other applicants, but as of now, we are just getting jerked around by the FDA in the exact same manner as every other player in the industry. It stinks, but it is what it is.
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diannedawn

09/14/10 6:36 PM

#26649 RE: BuyMyAsk #26639

"I cannot see the FDA being so ignorant, dis-organized and dumb"

I can! I'll bet in another month or so YOU will too :)