Well, there's no such thing as a sure thing, however, - years...

Well, there's no such thing as a sure thing, however,
- years ago I saw the statistics that something like 90% of drugs that successfully completed Phase III trials got approved. (I think the stats were something like 33% passed Ph II, 50% Ph III then 90% of those got approved, so Ph II and Ph III being the big barriers). That's a sweeping generalisation across all categories but shows that, in theory, approval shouldn't be impossible.
- Telix have already gone through the process with Illucix and so should have the corporate memory to go through the whole thing with less issues.
- the rolling review process means that the issues should have been identified and solved before the final submission.
My only counter to that is
- perhaps the familiarity and precedent of Pylarify made the process of getting approval more straightforward for Illucix, whereas Zircaix is the first product in its space and so the FDA may be more cautious.
Finally, I'd note that a single digit tail commission is still going to be pretty good money and not to be sneezed at. You'll probably make the sort of money that Neuren is making in royalties with its (admittedly very different) product.