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Re: bobby1151 post# 155231

Saturday, 10/20/2018 11:36:01 AM

Saturday, October 20, 2018 11:36:01 AM

Post# of 329202
The entire decision by the FDA relies on the statistical analysis of the back pain clinical trial. There is nothing else to discuss. The Actipatch for the knee is already approved and all they have to do is to change the picture on the box product for multiple use.

In the past, BIEL analyzed 5000 real world cases on the back pain specifically for the FDA, and the FDA requested the clinical trial. Now they get it and it is mind boggling why it is taking them that long to make a deterministic decision for saying YES or NO.

The fact they had questions and BIEL was able to send them a reply is GREAT NEWS. This means there is nothing that is very critical and things can be addressed within the 90 days based on FDA countdown.

It is coming on or before NOVEMBER 2nd.