Replies to post #139801 on Bioelectronics Corp (BIEL)

[markjohn62]

I was just about to post the same thing Art. I'm glad i read through the posts first. How can it be a "let down"? The alternative was have the meeting, wait a few days to get a PR saying we have a path forward. We skipped ahead, consider it a meeting with a positive outcome.

[srinsocal]

100 Percent Art,It takes a couple of months to get an FDA meeting. BIEL submitted their Pre-Submission documents and scheduled the 5/29 meeting to go over the details and any changes the FDA might request.

The FDA got back to BIEL and said, Your RecoveryRx Pre-Submission data looks good proceed with a 510k application. There was no need for the meeting, FDA gave the Green Light based on BIEL's Pre-Submission materials.

"Upon its review of the submitted information the FDA has provided written feedback and guidance for a 510(k) application to obtain expanded market clearance for treatment of postoperative pain."

We have the same outcome as after the 5/9 Back Pain Pre-Submission Meeting except the FDA saved the time and expense of the meeting by approving the 510k Path for RecoveryRx via the Pre-Submission data.