It was put in over 6 months ago. The clinical trail was expected...

It was put in over 6 months ago. The clinical trail was expected to finish end of July as per the clinicaltrials.gov website - this isn’t always accurate though. FDA website says a PMA submission takes 45 days for filing and 180 days of review without request of amendments/clarification. I’m sure it’s due any day/week.

TGA submission usually occurrs after fda. TGA and MedSafe is easy once fda is cleared.