You're exactly right. But what's most telling to me, more than all of the analysis about the substantive questions and issues that have been asked by the FDA, is the request by the FDA for an electronic submission of the application. If you watched that video I linked yesterday, produced by the FDA to explain the 510(k) process, you will recall that the last step of the process for an approved application is for the FDA to create an electronic version of the application to log into their system, UNLESS THE APPLICANT PROVIDES THE APPLICATION TO THE FDA ELECTRONICALLY. The FDA only needs the electronic version to enter into its system UPON APPROVAL. The only possible reason the FDA would ask Imaging3 to send the application to them in electronic form is to save the FDA the time and effort to convert it for purposes of loading into their system. If they were going to ask for more questions / information or they were going to deny the application, why on earth would they ask for the electronic version?
Rather than parsing the substantive questions, just ask yourself why they would make the request for the electronic version? I really think we are done.
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