There's no doubt, I think, that this program, the SAP, can fill gaps a bit better than perhaps is happening right now. For really ultra-rare drugs.... I mean, let's face it: Canada is a small country with a wide geography, and sometimes converting an SAP access into an actual ongoing open-label clinical trial.... That's another option: to convert patients not just into an approved drug in the country but to actually enrol them in the longer term in a clinical trial.
It's not that patients who are enrolled in an open-label extension trial always must have participated in the initial randomized control trial or experimental trial, so rather than necessarily using the apparatus to push through a drug to its commercial realization, one could imagine other exit strategies out of the SAP.
Of course, ultimately, as you say, getting the drug approved in a formal process would be ideal. Where the SAP could be better, in my opinion, as I mentioned in my talk, is in trying to fill the gap between Health Canada approval and the pCPA process. I think we need to shine some real light on whether that's an access pathway in the short term during evidence review.
Those are my thoughts around the longer term. Let's move people into a clinical trial setting and gather data from them, or perhaps move it into a marketed product.