I only say maybe soon because i don't know the intricacies of the JPMDA process. There's a reason mgmt shared that via Twitter....like a *wink* *wink*
according to the slideshow the audit of fscilities, which includes ISO cert, happens at the tail end of process. Means they already received approval of product and this is the final step for commercialization.
Once cleared in Japan, a large distro deal will follow.
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