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Sunday, September 19, 2010 2:40:59 PM
What is important are as follows:
1. We have NO OUTSTANDING INFORMATION at this point that needs to be responded to.
2. The last contact with the FDA was almost 40 days ago and at that time Deano said that the reviewer did not have any further questions or did not need any further clarification.
3. The last resubmission was over 160 days ago. We have come a long way and we are nearing the verdict.
4. All NSE's that have been issued by the FDA have been established in the early stages of the 510k application. We are triple the time of the longest rejection. We are out of the woods on NSE.
5. As Deano stated ... we can correct any issues with the FDA and as often as needed when we are classified as a 510k. We clearly are a 510k and we will get clearance for the Dominion.
I can go on and on but so much DD has been regurgitated here over and over again to simlify exactly where we stand in this process.
Let's hope this is the week of approval so we can lay to rest all of the doubt.
GLTA
JB
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