![](https://investorshub.advfn.com/uicon/496411.png?cb=1505403973)
Wednesday, January 11, 2017 4:36:32 PM
Release a Company Update or Press Release, Ed, and state in no uncertain terms: is the 510(k) still active, or has the application changed to de novo?
No more of this Safe Harbor "we submitted a 510(k)" smoke-and-mirror hype. We know you submitted a 510(k). We want to know the FDA's "pathway determination." We know they told you. Now tell us.
Also, Ed, what did BIEL file with the state of Maryland a few weeks ago if not a R/S or A/S increase?
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