General Forum, page-970

Hey @robrob , glad to see contributions from the likes of yourself. I suspect there are a great many, like you, watching from the sidelines, waiting for FDA clearance and the de-risking of the business that comes with that clearance before taking a position again.

I don't for a moment deny the effort required to get this through FDA, and the risk that comes with it. Should we achieve it, the competitive moat it creates is significant. I'm not privy to the process to date, and where the concerns are .... but my guess for what it's worth :

1) Trying for Over the Counter designation which entails a much bigger clearance hurdle. The predicate device, Oscar 2, is not OTC. We may now have opted for presecription only clearance ... as per the predicate device.
2) Several new biometrics as output from the Conneqt Pulse, again, not on the predicate device. I imagine a decent body of evidence is required around each measure.

Craig & Niall have continued to invest in the company infrastructure that supports the market launch of Conneqt Pulse ( people, call centre's. logistics support etc. ) My logic says that you would withhold this spend if you had concerns around the product being available in the market in the near future.

The FDA process for 510k clearance is there for all to see, the commencement of the Interactive Process ( part of the Substantive Review ) means that you have cleared the Acceptance Review . During the interactive process, the reviewer can request additional information at any time. The process then waits for the additional information to be supplied, and then once supplied, it kicks off again.

In the quarterly the comment was :

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.

The half yearly comment was :

The Company made good progress during the period in relation to regulatory approvals required for the Pulse.FDA has acknowledged receipt of the Company’s application for review and an interactive process commencedwith the lead reviewer where additional information has been requested and provided by the Company.The Company anticipates receiving clearance in the coming months

The difference : Half yearly says " provided " vs " providing "

I take that as the requested info has now been acquired & provided to the lead reviewer. There was significant costs attributed against regulatory process in the HY accounts, I suspect we had to do some significant quant type research to get the clearance over the line.
Hopefully, that's if for additional information requests, and we are getting close to clearance now.

Look forward to having you and @sam11212 back on the register soon.