Ann: Update to TGA Submission, page-91

no more trials - but they do have to do internal testing - and you'd expect they'd need to provide significant data from those tests as well - hence the "this calendar year" comment. I think it's less supply chain delays rather testing that is the cause of the delay before a resubmission. Any partner working with them you'd expect to be able to crank up the machinery to spit out three batches of product pretty quickly. It's the testing, data capture and validation and presentation of the data that would take the time.

Check back in this time net year...for punters, there's definitely a gamble on this one again in the leadup to the next submission.