Replies to post #153256 on Bioelectronics Corp (BIEL)

[uksausage]

90 days came from the company AW interview I believe .
I expect it should be before the year end there was a ton of data for the FDA to review and they will review every last cell of a spreadsheet.

[DewmBoom]

The 90 days is guaranteed. How you count it is unknown to us. The FDA and BIEL are the day counters.

Assuming no substantive questions, Biel FDA 510K WILL be approved either this week or at most next week.

[Simpsonly]

So right TMW.
90 days is a guideline, nothing more.
Companies making submissions expect questions when FDA is looking for verification of data submitted.

For example the back is nite and day different from the foot and knee. The bones of the foot and knee are very close to the source of the SWT....the ActiPatch. Not so with the muscles of the back and spine where many sources of chronic and acute pain are farther away because of differing BMI and deep within large muscles and tissue (fat).

Whenever differing data shows up, questions are asked and answers given. It's not complicated, but the data itself can be complex to compile and present, just needs to be explained properly so new questions don't arise. One tiny question can add a month or two, it's the way it is. My guess is a question was received after the latest Whelan online interview. That may take us to December.

ActiPatch...imminent Tsunami...breakthrough disruptive technology...