Based on the additional info asked for by the FDA their initial request and pausing of the review process last September seems rather capricious.
They asked for additional data comparing the mixing pressure done by hand with the current device relative to pressure applied mechanically by the GO device.
I don't believe they asked for pressure data for the original approval, which seems to me odd they'd ask for it now. The endpoints were met in both cases with whatever pressure was applied so the question seems a bit pointless to me.
In other words, think they should have gotten approval last December. Assuming Avita has addressed the question satisfactorally no reason it shouldn't get approval in May.
But see my capricious comment above. Nothing guaranteed with the FDA. But it should be approved.
Based on the additional info asked for by the FDA their initial...
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