Davethedog,
It could just be misinformation. They do no know. They keep harping about 300 patient trials over several years. This is NOT an FDA trial it is a CE Mark.
This will be cleared once the meeting is held between the three parties. The Device works and meets and exceeds the minimum requirement for a CE Mark Approval.
OSLwill then move on to the much bigger trial in the US which I am sure will take time and money but hopefully will achieve the same excellent clinical data as it has achieved in these smaller trials.
Davethedog,It could just be misinformation. They do no know....
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