RE:RE:RE:RE:Holding Pattern Did not mean to mislead anyone with my last post, as I truly believe Helius Medical will file any day now.
The meeting with the FDA did happen in early July and they did not require any additional studies. At this point I am pretty sure the submissions are completed and ready to be sent to the regulators in all geographies (management wants to file at the same time).
I am somewhat speculating here, but I have seen this before with another company. There is an administrative follow up required following the meetings with the FDA. Some kind of paperwork has to be completed and sent to FDA, which then has to be acknowledged as received by the regulator before the submission can be sent. With August being the peak season for vacation, I would not be surprised the low staffing levels are leading to this administrative delay.
So next 30 days?
Submission with the FDA, Health Canada and CE Mark in Europe. This will be press released no doubt about it.
I believe the CEP (Clinical Experience Programs) at the clinics should start any day too. Recall, Helius will be treating patients in a real life setting (no sham/control arm studies) in one of the 5 or 6 CEP clinics (which will be the first to launch the PoNS commercially). The data will be open, and thus Helius, the clinics and the payers groups (insurance/workers comp) will be able to quickly assess how much money will be ultimately saved by treating the patients with the therapy (economic benefit).
Prokofiev