Bioelectronics Corp (BIEL)

[Chyna9]

I don't think there's a 'winner' but rather a group (of unknown quantity) of entrants that get selected at some point in November for extra assistance to get the product to market. This would include significant support direct from FDA or an affiliate to get 510k expedited, etc.
There will be multiple entrants chosen in November and any entrants that successfully complete the necessary process post-selection will be labeled a 'breakthrough device' by the FDA.

No idea on how many applications there were (that window has closed), how many will get accepted (will be announced at some point this month), and how many will end up on the market (will take some time but will be fast relatively speaking to the norm).

IF BIEL were to get accepted, that would obviously be a huge success. If they got accepted AND successfully completed the process post-selection, that would be mega huge success.

IMO you are absolutely correct that IF they do get accepted into the challenge, that would be a mega event. It would not make the product 'fda approved/cleared' but would get the ball rolling very faster than normal. And entering the challenge was said to be done for exactly that reason.

MHO is that they won't get accepted to proceed but hope they do for investors' sake. Would/should be good for pps, which appears to suck more and more.

Q3 numbers will be out soon. If they are decent it might stop the bleeding in pps. Dunno if any more dilution lately, haven't been watching but I assume there's been at least some.



glta