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Monday, October 10, 2016 9:38:36 PM
"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 than what was applied for and it is intended to expand the indication. The 510(k) pathway to clearance is 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 USA 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." Soon
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