Bioelectronics Corp (BIEL)

[Daytime_Lantern]

Of course, the following statement is taken from BIEL's most resent PR: "As a side note, the Company is preparing to file its response to the FDA’s request for additional information on the postoperative pain 510(k) application, within the next week." What????!
Why is there always "additional information" requested of BIEL during the FDA clearance process? Is the culprit the FDA, or is it BIEL? Though it's JMO, but I would tag the latter. By now, wouldn't a reasonable person think BIEL should know exactly what data/information the FDA expects to receive, in order to give clearance? This is ludicrous folks! BIEL has at least one PHD on staff who is intricately involved in the development of their product, and they can't figure out what to provide to the FDA to obtain clearance. Something is seriously wrong here folks!!

GLTA!!!