Bioelectronics Corp (BIEL)

[Simpsonly]

That the new FDA Class II designation will happen, I think, everyone is confident of, since the FDA itself initiated this process. That said, it is a certainty that, on publishing of the Final Rule in the Federal Register, BIEL will apply for Class II designation approval for its products ASAP and also apply for OTC approval, I would think, simultaneously.

As to the timing of the process, the FDA staff have communicated that they are aware of the importance of this, that they are working on the drafting of the Final Rule, and stated that they hope to have it completed in a "timely fashion.". All meaning the timing is speculative. I believe their self-mandate is 180 days following the publishing of the Proposed Order in February and I think that was up around August 22nd, given that an FDA "Day" is defined as running business days, but excluding project hold days, requests for further info and data and the like and, to our knowledge, this baby has not been on hold. Wish I could say more fbs. To do so would be biased and misleading speculation, either for or against.