All the regulatory evidence confirms CE "progress" ended shortly after the "expedited" review in October 2015 - over 8 months ago. And US "progress" spectacularly stalled in early January 2016 with the FDA disapproving the proposed IDE study.
There is insufficient cash to complete the required trials to secure approval in Europe or the US.
Could non-existent governance and an egotistical management team with poorly matched skill sets have resulted in this epic fail? The evidence is clear to all who chose to see it. The emperor isn't wearing any clothes.
OSL Price at posting:
12.5¢ Sentiment: None Disclosure: Not Held
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