I hate to sound flakey, but the 60 days could be up anywhere from June 7 to June 15. The math on the 60 days is just as fuzzy as it was when we thought it was a 30 day review cycle. The two things we know are that: (1) the count is not triggered until the FDA receives the package, not when Imaging3 sends in the package; and (2) we are dealing with calendar days not work/business days. Even though we sent the package both electronically and by hard copy, the FDA did not process and announce receipt of the package until April 9.
Here's where it gets a little less certain. The first uncertainty is whether it's just 60 days or 60 days plus the extra admin days we have heard about. We have been told that the 60 days does not include some administrative time for processing the application, processing the final vote, updating the FDA's system and processing the response to the applicant. We have heard this admin time takes up about 8-10 days, but I believe that includes days on the front and the back. Since we already factored in 4 days at the front (package sent on the 5th and receipt announced on the 9th), I think we can just add 4 or 5 days on the end rather than 8 to 10. So I'm going with 65 calendar days.
The next uncertainty, is what day we actually start counting. Assuming the clock works at the FDA like it does for most every other bureaucratic agency, the 60 day count is triggered by receipt, but does not start until the day after receipt. Since receipt was announced on Friday, April 9, the next day was April 10, a Saturday, so it's likely the FDA starts counting on the next Monday, April 12. So I'm going with 65 calendars days beginning on April 12, which works out to June 15.
Since I used the conservative assumption in each scenario, I would consider June 15 to be the outside of the window (i.e., the latest possible date that the FDA could claim they achieved their 60-day goal). Taking the least conservative assumptions; i.e., (1) the clock starts on April 9 (the day the FDA announced receipt of the package); and (2) there are no admin days because the response will be sent by fax not snail mail, we would count 60 days from April 9 (including April 9 itself), which gets us to June 7.
So I say the 60 days is up anywhere from June 7 - June 15. Or in terms that are more important to me, starting 6 trading days from today.
There are three other points that I want to make. First is, the FDA self-reports that it meets this goal 90% of the time. Bureaucracies are not efficient. They do not have a high success rate. Achieving something 90% of the time is extraordinary for a bureaucracy. The only way they are really hitting this target 90% of the time, is if more often than not, it takes them far less than 60 days. It is highly unlikely that they are meeting their goal 90% of the time by getting right up to the final date in most cases. That is bolstered by Dean's repeated statements that in his experience the final review is usually completed in 30 days. It makes more sense to me that the FDA tries hard to, and does in fact, get most done in 30 days, if it is able to hit the 60-day goal 90% of the time. That's why I continue to believe that it is "any day now" not just June 7 - June 15.
We have also seen in our own experience on this Board that most announcements of Approval / Clearance come on Fridays. There are 3 more Fridays before and during that June 7 to June 15 window: this Friday, May 28, the following Friday, June 4 and the Friday after that, June 11. I will continue to put my money on a Friday approval, and those 3 Fridays look great to me.
The final point, and the one I hate the most, is that this 60-day review cycle is JUST A GOAL / GUIDELINE. For 10% of the applications sitting in the exact same position as the DViS application, the FDA review takes longer than 60 days. There is no recourse for the applicant and no consequence for the FDA if it takes them longer. It wouldn't be the first time and it won't be the last time if it does take them longer. I continue to be confident that our announcement is imminent, but there is nothing that requires that to be the case.
All of that being said, I think we will hear one of the next 3 Fridays and I think it will be positive for several reasons:
(1) Since filing the application on April 5 with at least two positive Radiologists' Reviews, Imaging3 has had a couple of brief phone calls and emails with the FDA during which the FDA made informal requests for "minor" issues, which have been reported as two minor language changes in the manual and a request for the full application in PDF form, a format that can no longer be edited or redlined.
(2) Dean responded to those 3 minor requests immediately, and has not heard a peep out of the FDA since.
(2) Dean posted new 3D imagery from the DViS. Dean has insisted for as long as I've been following Imaging3 that he would not produce any new 3D imagery until he had Approval in hand or some virtual guarantee that it was in the bag.
(3) The FDA has loosened it's strangle hold on radiation device applications, and we have started to see radiation devices get approval again.
(4) The bashers have gotten more desparate and more frequent.
It's going to be good news and it's going to be imminent. Good luck to all.
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