Replies to post #139769 on Bioelectronics Corp (BIEL)

[seven-up]

While RecoveryRx is already US FDA cleared and available for treatment following eyelid surgery, the expanded market clearance would allow use by millions of Americans annually, who undergo a surgical procedure including hip and knee joint replacements and general surgery. RecoveryRx provides an adjunctive or alternative treatment to analgesics for postoperative pain and can reduce the need for opiate analgesics during postoperative recovery. 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.

Of course, this is going to save a lot of time, money, and will lead to a quick clearance.

[art2426]

There is absolutely, positively NO WAY anyone can interpret this, or twist this into being anything BUT POSITIVE! There is no NEED for a meeting. The path to FDA clearance, in how to submit a 510k for obtaining surgical post operative wound care for the Recovery RX, is already understood by the company due to prior relationship with FDA and similar products. The Recovery RX HAS BEEN CLEARED previously. This is only for clearing the product for more uses in post operative care.

It is obvious that the company feels more comfortable with its relationship with the FDA due to previous meeting and dealings with them for prior clearances, to see no need for another meeting. They are confident on how to proceed. Yes it is not a clearance YET, but neither was the meeting for similar context of clearing Smart Insole and Knee Patch --- and we all know what the result was, of that.