They stated from todays PR...While the FDA response to our De-Novo application is very past due, we just submitted answers to the FDA concerning our RecoveryRx post-operative pain and edema application. Even though most of the FDA questions focused on the technological side, the questions were both straight forward and very reasonable. Therefore, we responded with complete, direct answers. We hope to reach clearance soon.
When I talked to IR they said via the FDA this was all that was needed and a decision should come soon. Again ...we shall see..
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