Replies to post #39666 on Bioelectronics Corp (BIEL)

[Dubb10]

Well, at least mostly not what he was saying.

REDZONE is confident that Biel will gain FDA OTC clearance by July. If you know the FDA process, you know they don't work that fast, especially when the FDA hasn't finalized the Proposed Rule yet and that rule hasn't become effective. After the Finalized Rule becomes effective, Biel would have to evaluate all of the criteria for the special controls in addition to the regular criteria and then submit their 510(k). Then the FDA would begin the review cycle. As a trend, the FDA takes in the neighborhood of 5 months to fully review (and clear) 510(k)s according to Emergo Group:
http://www.emergogroup.com/research/fda-510k-review-times-research
I have seen cases where the FDA granted clearances in less than 90 days. Keep in mind that this is an area that the FDA and other government agencies say they feel they need more data on.

IMO, there is no way Biel gains OTC clearance by July. I believe they eventually will, but I don't see how anyone can make precise predictions when no one knows the final requirement by the FDA, and whether or not Biel satisfies those requirements. That's unless REDZONE has inside info on both the FDA and Biel.