I think less than a year for FDA Remplir approval Speckled. They passed the 510K pilot animal study in April 2021. If its another year from here, that would be a disgrace. Suspect the upcoming 24 month full Remplir nerve results will provide a basis for some sort of fast-track approval with the FDA, particularly given they are TGA approved and had already met the FDA's pre-requisites for 510K (I think not just taking 510K a strategic error, but hopefully they prove me wrong).
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