Bioelectronics Corp (BIEL)

[Probity]

Want to clear up a few things in getting to your question…

When a company’s FDA - cleared product patent expires…

1. Another company cannot use BIEL’s clearance(s) by simply replicating the product.
2. They must submit via 510(k) process, Premarket Approval (PMA), De Novo classification, or other regulatory pathway via new application(s) for FDA clearance to market.
3. An expired patent for BIEL does not “expire/cancel“ the 5 FDA clearances for BIEL, nor are they transferable to another owner.

BIEL can still sell product as they do now, and with any FDA registered and inspected assembler (currently Chenzen). Again, BIEL owns the 5 clearances; they don’t automatically transfer to another owner.

So, BIEL would not have to do anything different if they choose to pair with a different FDA registered assembler.

That #2 above was a very messy process for BIEL way back when . Another time it was an initial pending clearance for females but not males. Attorneys with FDA specialty cleared things up for BIEL So it could be a messy process, or maybe not, for a new owner.

Flip a coin.