Bioelectronics Corp (BIEL)

[yankee55]

Very beneficial to repeat seven-up as it has significant implications for Biel:


Comments to Proposed Order

1. "Documented clinical performance testing must demonstrate safe and effective use of the
device. This requirement would mitigate ineffective treatment." (Special Control #4)
a. Clinical Data are Not Necessary and Should Not Be Required as a Special Control
for Concerns of Ineffectiveness.
Regenesis does not believe that FDA should require clinical performance testing as a special
control for nonthermal SWT.
FDA's stated concern is that clinical data are needed as a special control to address a stated risk
of ineffectiveness. We respectfully but firmly disagree that new clinical data must be required,
because substantial valid scientific evidence already exist to demonstrate a reasonable assurance
of effectiveness for nonthermal SWT.