I don't think that is quite correct.
First of all FDA approval has has not been mentioned recently and second it will be the better part of 6 months once they make application.
Now my last inquiry into this the company had not made formal application and that was about a month ago.
TGA and EU applications and approvals have had a lot of fanfare of late. Nothing has been stated about the FDA.
So I'm not sure where you got that from.
Still a long way off
Cheers
BW
fda approval, page-5
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