Hey Steve - I don't buy the "scheduling conflicts" of key participants at all. The April 5th meeting involving numerous applicant firms and the BIEL technology was scheduled in November (?), 5 months ago, when all key participants would obviously confirm to the staff member they could attend April 5th. Then, March 8, or so, one or more of those key participants popped up and said, "opps, sorry, busy that day"? Nope, don't buy it. I can't see anyone at FDA risking their credibility by hanging applicant firms out to dry, as well as their colleagues inside who now have that space open.
So, we need to know what is really going on. As I said last week, if the news was to be negative in terms of OTC approval for BIEL and other applicant firms, the FDA would make that determination without the public meeting? A total reversal to be advised later? Nope.
Is is related to a more definitive undrstanding by the FDA of the need or viability of a new device category, which heretofore they did not have a handle on because of a lack of staff qualified to assess PEMF?
Has someone in DC asked what is going on and why all the delays and undercurrents about new categories? I hope so, about time. Is it about face-saving?
The few things we know are BIEL products work, there has been zero information about negative side-effects, the company announces today about new IP patent protection at USPTO (thanks wyatt) and approved for OTC sales in Canada, the UK and elsewhere.
There is someone somewhere who can confirm the reason for the 5 week delay in the public meeting the FDA called by them for April 5th to May 10, if the PEMF matter has actually been added to the May 10th meeting agenda. Someone knows.
