There is no way that the company would have had the opportunity by this date of "gaining or ensuring" FDA regulatory approval via 510k of the BTM. The most that could have been accomplished by now is the lodging of a 510k application, and I know of no one in the public who knows that the company has (or has not) done this.
Have you been given any special insight into this that has not been afforded to the rest of us?
CZD Price at posting:
10.5¢ Sentiment: Buy Disclosure: Held
