Word for word from QR:
’Evidence of a satisfactory safety profile overall with no CONVINCING evidence of SIGNIFICANT safety concerns or unexpected/serious toxicities associated with the investigational device’
So my interpretation is that there was clearly some evidence of significant safety concerns.....
It’s just as OSL stated, no convincing evidence. That to me is a possible foot in the door for the CE Mark crowd to withhold approval.
I’m genuinely after people’s opinions as I’m looking into taking a position in OSL but this point stood out in my eyes when reading the QR.
