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Re: None

Thursday, 09/02/2010 3:38:20 PM

Thursday, September 02, 2010 3:38:20 PM

Post# of 59550
More support for BennyJ's view of the Review Clock, from the now infamous Heather Rosecrans:

"FDA Requests Additional Information:

* Reviewer requests by telephone, email or letter
* Clock stops by letter only "

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126288.htm

Imaging3 did not receive any information requests by letter from the FDA regarding the April 5 submission. Accordingly, the clock didn't stop, and since the FDA is hitting the 150-day mark 100% of the time, we should hear from them any time from right now through this time next week. Time to load up.