2020, page-3

I agree, there has clearly been issues getting the FDA clearance. I'm banking on us getting there, but for whatever reason ( " perhaps shooting for OTC at this stage was one step too far " ), clearly the lead reviewer has asked for additional information during the process. In fact the quarterly stated as much. Hence, buyers ( other than us LTH's ), are waiting in the winds for Conneqt Pulse to massively de-risk.

From the quarterly :

The Company continued to make good progress during the quarter in relation to regulatory approvals required for the Pulse. FDA acknowledged their receipt of our application and has accepted it for review. We kicked off the interactive review process in Q4 where we are corresponding with the lead reviewer and providing additional information as requested. We anticipate receiving clearance in the coming months.

These are carefully selected words by Craig, and relate directly to the FDA guide on the process ( see below ).
Essentially, the process kicks off once the official review period starts with a substantive review
However, if "additional information" is requested, the official review period goes on hold until the additional information is provided by the applicant & accepted by the lead reviewer.


So, my summation & guess, we had a request for additional information back in late Q4, we then had to acquire that information and submit it.
I'm guessing this has been done, accepted by the lead reviewer, and the process has re-commenced.
Hence the " Q1, 2023 " launch date on Conneqthealth website and Craigs constant "imminent" comments.
Of course, what he can't be sure of, is if the lead reviewer asks for additional information again.
Again, I'm guessing, but it could be that the move from OTC to prescription has eased the requirements from the Lead Reviewer somewhat.