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Re: Simpsonly post# 37239

Thursday, 04/24/2014 2:28:18 PM

Thursday, April 24, 2014 2:28:18 PM

Post# of 328753
Thank you Simpsonfly for taking the time and effort to thoroughly detail how Biel can address the new proposal outlined by the FDA! It also seems apparent to me that Biel has the innovative technology backed up by numerous clinical studies to treat a broad spectrum of pain issues. All the points that you state are indeed what the FDA desires to embrace going forward. The beauty is that Actipatch is a safe and effective device which is all the better in the eyes of the FDA....a low-risk treatment device if you will. The FDA will look at the 501k submission soon and be very pleased imho! Thanks also Raven for the great find!