Wednesday, March 10, 2010 4:58:44 PM
I think we are ALL on the same page that the Radiologist opinion (i actually hear it is TWO radciologists not just one) is the key...once that has been completed in a favorable fashion this thing is APPROVED!!!
it has to be!!! the FDA is looking for some third party to endorse the device as they are having a hard time understanding it...so they want an expert in the field to write up a report
it is something they can hang their hat on....Dean will elaborate on this and explain why it has taken so long to complete the report.....
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