Hold the champagne srin - this was another meeting with FDA on the answers to the last group of FDA questions that BIEL announced they would provide answers to before yesterday's meeting . . .
I have assumed since that they are addressing Special Control protocol and label and insert texts. Those, when agreed to, will then require final review and agreement by the parties, then drafting of communications, legal, schedules, media PR's, political announcements, all negotiated, all agreed to, all in final form. All those take time.
What I'm looking for is intel that the tsunami continues to build toward landfall. Some tsunamis move at 800mph, government agencies do not. That's fine with me as long as we have forward movement. Patience, and stay thirsty . . . . "shortly", was what the FDA stated as the timing of the possible decision to move toward the 510(K) route . . . shortly works for me just fine . . .