Based on the circumstances we find ourselves in (i.e.: (1) a submission following a second or later additional information action request; and (2) the FDA has already consumed 90 cumulative days of review time across all the previous and the current submission), the FDA's goal for getting Imaging3 a response would be 60 FDA days from receipt of the submission (a goal they achieve 90% of the time). We know that the FDA announced receipt of the package on April 9. Based on my analysis, that 60 FDA days period expires anywhere from June 7 - June 15.
We have also observed that most approvals come out on Fridays (probably because the Board meets to vote on the review teams' recommendations on Thursday afternoons or Friday mornings). The only Friday during that 60 day window is next Friday, June 11. If I were a betting man, and I had to pick a date, I would go with June 11. I also wouldn't rule out tomorrow, the last Friday before the 60-day window starts to close.
Anything after June 15 and the FDA has no credible claim that they achieved their goal/guideline. Of course, that and $2 will get you a cup of coffee at Starbucks.
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