Bioelectronics Corp (BIEL)

[jaysolano]

DewmBoom - read my post.

My assumption and opinion is either:

- They could have provided more information with their PR, if they in fact did apply for FDA EAP. Not sure they would leave that off, as it would be an EXCITING thing to convey to investors, and being approved would help suggest that even the FDA considers Actipatch a "Breakthrough" device.

On the other hand....

- Maybe they did discuss EAP and for one reason or another were told it may not or would not meet the eligibility requirements and rather than apply and being denied (bad publicity) because FDA did not consider it to be a "Breakthrough" (TERRIBLE publicity), they opted for the "TRADITIONAL 510(k)" filing as they mentioned in the filing announcement PR.

All my guesses and speculation here.


I guess it's a simple phone call or email to ask your BIEL contacts for clarification if they filed for EAP or not, or if they discussed with FDA whether or not Actipatch for the expanded clearance may be eligible for EAP or not.