Replies to post #139046 on Bioelectronics Corp (BIEL)

[JNdouble1]

Well, that may be so.

Also, it may be that the agency "provided constructive feedback" on how to execute the combined 510K. That feedback would likely include some recommendations that Biel would want to incorporate into their package. yes, this could take days, or weeks depending on the feedback they received.

Either way it is a new filing which will need to be considered carefully and fully by both Biel and the FDA. I would like to think that the company will announce when they execute the formal submission.

I think "expedited" in federal agency speak still means 30 days or more (after submission). I am as hopeful as most here, but I would hate to see the unrealistic expectations causing folks to become disappointed when the approval doesn't come as soon as they may want/expect it to.