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$BIEL Alert....FDA Meeting on May 29 and Earlier on May 9

Buy and Hide your shares deep inside the mattress

May 9 Meeting: Relief of Musculoskeletal Pain Market Clearance Application for Actipatch......WILL BE APPROVED ANYTIME NOW

Dr. Koneru, who led the discussion, expressed confidence in the FDA’s constructive feedback. “We are pleased that the FDA viewed our data and statistical methods favorably. They have provided guidance on how to combine the back-pain study results, along with our previously cleared 510(k), into a single 510(k) submission for obtaining expedited expanded market clearance.”, he said

May 29 Meeting

An additional pre-submission meeting is scheduled with the FDA on May 29th, 2018 to seek expanded indications in a separate application for OTC treatment of pain and edema following surgical procedures for its RecoveryRx® medical device.

http://www.bielcorp.com/investors/fda-status/