I am not certain, but I'd be pretty sure that unless the FDA agree / audit your results they would not announce anything , it would be foolish to announce them to the market before that. Just think of the backlash you'd encounter if the FDA came back and said sorry try again and you had to announce that to the market.
If I was the one making the call whether to announce results or not I'd wait for the nod from the FDA ... but I could be well off the mark.
IMU Target $2.00 - Not Ramping !!!, page-119
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