Bioelectronics Corp (BIEL)

[srinsocal]

Thanks for posting this letter seven. This Dr. Isenberg & his lawyer have all their arguments presented very well with precedent. It is long but take the time to read it if you are a BIEL investor.

I would say that the Final Order is definitely getting a few changes.

One of my favorite sections:

For the reasons above, Regenesis respectfully but firmly requests that FDA reconsider the proposal to require submission of additional 510(k)s for already cleared and unchanged devices.
We note that, absent any reasonable justification by FDA for requiring new 510(k)'s for these devices (as distinct and apart from new requirements for their compliance with special controls), the agency is bound by its precedents to the contrary. "An agency must treat similar cases in a
similar manner unless it can provide a legitimate reason for failing to do so." Indepen. Petroleum Ass'n of Am. v. Babbitt, 92 F.3d 1248, 1258 (D.C. Cir. 1996), quoted in Prevor v.
FDA, No. 11-1187 (RMC), 2012 U.S. Dist. LEXIS 136569 (D.D.C. Sept. 25, 2012).