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clock Created with Sketch. 26/09/22
09:28
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Originally posted by Okanemochi:
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Well I agree with ART, and we know there are issues as Derek clearly told us (in his famous webinar) there was a manufacturing problem effecting the quality of the product due to Particle Aggregation. He even went so far to say that: the poor sales figures from Europe were directly attributed to this issue and that it had not been resolved.
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I contacted the company directly about this and the issue raised by Derek had been resolved..the biggest crux is Common Lists approval requirements, which, had the company been more nimble earlier in 2021 could have jumped in with the EUA approvals when the pandemic was at its peak hysteria... Now the medical device approval process is strict and onerous, for good reason.
(20min delay)