If you look at the trial timeline, then they will go onto OLE...

If you look at the trial timeline, then they will go onto OLE (Open label extension) & have access. If the drug is approved, then can go onto whatever is approved into each jurisdiction. It is an ethical consideration that trial patients continue to get drug that is helping them. They can get access up to 2 years of the drug I believe BTB, to give time for approvals for patients who have kindly participated in our trials.

That would be incredibly poor if they need to come off treatment before a drug approval, it can happen with some trials & can be an ethical question on whether some PI’s at trial sites will accept a trial or not, as patients come first, & if benefiting & going backwards.

DXB has always offered compassionate supply via Special Access Scheme scripts via the TGA, at least since Ph1/2A that I have been aware of.

What happens here is compassionate supply with Special Access Supply Scripts, then once the drug is approved can be ‘Grandfathered’ across to PBS, or whatever the relevant process is in other jurisdictions. So compassionate supply from the company. Hope that helps. There is mention of this in Ph3 ACTION ANNs.