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Post# of 1647
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Alias Born 12/15/2011

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Monday, 10/10/2016 11:22:55 AM

Monday, October 10, 2016 11:22:55 AM

Post# of 1647
I posted this on the ihub board a few days ago concerning FDA clearance for Actipatch from my conversation with Andy. Hopefully this clarifies some of the concerns regarding their concerns; He was very easy to contact and pleasant to talk to. I asked him about the FDA, ibex, dilution and sales. He stated that the FDA requested more clinical data, which biel provided this week. He stated that the reason they needed further data was because musculoskeletal use is a much broader application. The 510k path is still alive and well. There will be a press release from biel giving us an update on some of these matters soon. There is more info to be presented regarding ibex. He couldn't say much more about it. He also stated they are close to not having to dilute any more. Sales are expected to increase with the new store additions. He said with FDA clearance in the us it would take four to six weeks to have product to supply Walgreens and any other stores that would stock Actipatch. He also stated there are continuing studies for bladder related issues. Feel free to post on the liar board. Less

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