Honestly, I don't think so. The FDA has explained on its website that minor questions or requests for information that it asks by way of email or telephone correspondence with the applicant DOES NOT RESET THE REVIEW CLOCK. The FDA's guidelines very specifically state that if a question or request is going to stop the clock, they have to send the request by hard copy and/or follow-up the request with a "Hold" letter. Such an event would, in my opinion, trigger an 8K filing by Imaging3. As we have not seen any 8K from the Company, I do not believe the mid- / late- April minor language requests would have any affect at all on the review cycle.
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