This is my understanding (obviously you should be doing your own research).
The co had a meeting with FDA at beginning of year, to clarify what exactly is required for them to gain approval. It will involve a clinical study and timeframe is projected to be 1-2 years to complete and gain approval. Clinical studies in this area are not overly complicated (compared with those testing a new drug). That said, things often take longer than expected.
This is my understanding (obviously you should be doing your own...
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