We were probably expecting AN announcement/update by now, but THE announcement is really hard to put a timeframe on. It looks like the Directors of OSL have learnt a lesson re over-promising an under-delivering in terms of the previous CE Mark review. Having said that, as a device, it would be an extremely detailed review covering not only the device/delivery mechansim but also the just-in-time manufacture, transport, and handling of the 'hot' payload. So, where the 'average' device approval takes c16 weeks, this may well be an outlier...
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