FDA approval is a given its just the timing. There was a post on another thread (may have been RAP) that has a report from FDA deNovo approvals being held up due to 2019 applications volume. They had increased approvals last year by 18%, but due to volume this year, they are delayed. It will happen but may happen when we are already making good revenue in UK, SG, Japan & NZ and even in Europe
PD will let us know soon either way. Lets hope we are high in the list anyway
FDA approval is a given its just the timing. There was a post on...
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