Bioelectronics Corp (BIEL)

[markjohn62]

Hey, Art.

This from Paul K.

We are planning to submit both the 510(k) for post operative pain and an application to participate in the FDA's Innovation Challenge. The participation in the Innovation Challenge presents the opportunity to get an indication of use to mitigate opioid use.

We do not have a schedule yet for the Allay product.


Does that mean they will submit the 510k in September? Wouldn't they ask for a pre-submission hearing first? # months to gather entries and then 2 months review them. How long to definitively clear them after the challenge, days, weeks, months? I am all for submitting ASAP. I'll see if Paul can clarify.