Waislitz in Australian, page-43

Re "The words “in parallel” would suggest pre-approval, no?"

Yes, you'd certainly think so and I remain of the view they will need to run this trial before approval. Nonetheless, as is so often the way with this company, the suggestion that the 2nd trial will start after approval has been left tantalisingly hanging around.

Much like the tantalising promise of the test for "overwhelming efficacy" to bring forward FDA approval for the CHF treatment.

That little pearl would have emptied a few pockets in the run up to the market being unapologetically told that it was essential that no trial results at all be released and, with that, the overwhelming test was impossible.