Bioelectronics Corp (BIEL)

[askjsell]

"THERE IS NO SUCH THING AS 100 day mark. "

You are incorrect.

From the FDA website:
"If FDA does not reach a MDUFA decision within 100 FDA days (i.e., 10 days after the MDUFA goal), FDA will issue a Missed MDUFA Communication, which is written feedback to the submitter to be discussed in a meeting or teleconference, including the major outstanding review topic areas or other reasons that are preventing FDA from reaching a final decision, with an estimated date of completion."

Thus, the FDA has communicated the reasons for not approving the 510k to BIEL....BIEL knows the truth, they are just not sharing it.