Pretty sure thats whats happened. They had discussions with...

Pretty sure thats whats happened. They had discussions with Medsafe and then said they would need further trial data before marketing. No announcement was ever made in regard to the Medsafe discussions and no announcement of a formal submission. Then the news that they had called in experts to review the results which were accepted as "relevant" but didn't meet the criteria for significance.

So the trial has been declared a success on the basis of safety and sufficient indications of efficacy at the 80mc dose to allow the DSMB to permit a future phase 3 trial. But since Medsafe hasn't given permission for them to sell it in NZ, the patients can't be asked to fund their own treatment. So now it seems they will need to find a someone with deepish pockets to cough up the necessary funding for a trial.