Saturday, June 09, 2012 11:21:42 AM
What is also encouraging is that another meeting is scheduled in July. FDA isn't putting BIEL on the backburner - they have set up another meeting one month away. That is a good sign as well.
Sounds like FDA is willing to reconsider the Allay application at this point. If Allay is approved, than Actipatch would seem to be easy (already have a predicate device in place). The only reason RecoveryRx needs a separate meeting is because it's a different product with a higher power level that can only be prescibed by physicians.
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