Wednesday, September 20, 2017 1:09:35 AM
I am not a die hard AW fan but I do love my ActiPatch and AW made that available to me so I will provide a rebuttal:
<<1. Promised a $50 million licensing deal done as soon as FDA clears>>
This statement was made with the assumption of Full Body Muscoskeletal Clearance. We got Knee and Foot so the deals AW may have cooking are not going to be triggered yet. Taking the Knee and Foot Clearance was the right thing to do. After years of battling the FDA BIEL needed this Win and I am sure Goodwin Proctor told AW the same thing. I was concerned that that the FDA would Clear but leave us in a Prescription only status so breaking the OTC Barrier is the big Win here IMO. Full Body will be a breeze compared to the OTC issue.
Remember BIEL is the first and only PSWT (formerly PEMF) device to ever gain FDA OTC Clearance. Anything else currently on the market that is PSWT of PEMF is a "Wellness Device" with no research by the FDA as to effectiveness. FDA Clearance is the Gold Standard around the world for medical devices.
<<2. Chain stores sales, specifically CVS, in 3rd or 4th qtr. 2017. (99% chance a lie.)>>
I would agree that if CVS was in the bag BIEL would be promoting it now.
Once again we have the Knee/Foot vs Full body issue. The move to one Body Generic product is an attempt to let the consumer know that ActiPatch can be used wherever pain occurs. Also 3 months and 11 days until the 4th quarter ends.
<<3. In over 8 years he never started a clinical study for Back & Menstrual pain. That's why no full clearance from FDA.>>
IMO BIEL was relying on the Oxford Back Trial which was initiated in 12/2015. Obviously it has been delayed by Oxford as it is still not complete 20 months later. One could argue BIEL should have done their own Back Study 5+ years ago. The good news is a BIEL sponsored Back Trial is underway and will be complete by Q1 2018 if not before.
There was a 91 participant Menstrual Study done in 2013 by BIEL that showed a significant pain reduction. Apparently the FDA does not consider Female Parts as important as Backs.
http://www.bielcorp.com/biel/wp-content/uploads/2013/03/Allay-Clinical-Study-Ian.pdf
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