Bioelectronics Corp (BIEL)

[srinsocal]

Moving The Goal Post

The "Usual Suspects" have been hammering away at BIEL for months saying "the 510k is dead", "just look at the Investor Updates", "they say nothing about the 510k", "just FDA Market Clearance", "this means they had to switch to a DeNovo".

Today we get a PR that begins by listing the attendees,"the three reviewers for the ActiPatch® Musculoskeletal Pain Therapy 51O(k) premarket notification".

There it is, in print, an official statement from BIEL, cleared by the lawyers, saying "three reviewers for the ActiPatch® Musculoskeletal Pain Therapy 51O(k) premarket notification".

Why would the FDA be paying 3 reviewers for the BIEL 510k to attend a meeting regarding a 510k that has been denied? If it has been denied there is nothing to review, they are off of the BIEL 510k and reassigned to other applications.

The answer is the FDA would not have three reviewers there unless it was an active application. So what do our "suspects" do? They change the narrative to, "too many meetings mean the 510k is dead". These boys should go into politics. I am sure Hillary and Donald could put their spinning talents to use.