Thank you so much for sharing and breaking down! So much clarity and extremely positive!!! They haven’t gone as “public” with their moves this time around, which I actually appreciate and is likely a strategic move at some level :)
What part of "As part of a PRE SUBMISSION meeting process" " This review typically takes SEVERAL ITERATIONS and we will continue with biocompatibility testing in parallel", don't you understand? If you keep reading it I'm sure you can convince yourself it will be approved for human testing any day now. LOL. It's months away from applying for human testing at best.
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