Your question is a naive one in that you are assuming approval. Just because a drug shows better safety, or strong indications of efficacy along with safety, doesn't mean that the FDA will sign off on it. As many posters on this board could second, I wouldn't hesitate to demand Citicholine if I (or anyone I knew) suffered a stroke. Problem is, it was never even filed with the FDA. (See Dr. Tracy's website for details.) And I guarantee you that, had it been approved on its available data, no physician would have hesitated to administer it to me.
I posted a long message on the PTIE board addressing this and other PTIE-specific issues. Thought it germane to reply here as well because the point made above is a relevant issue to all biotech investors. What one company, the public, and/or the medical community think may be sufficient (for approval of a new drug), does not necessarily mean the FDA will hold the same view. The advent of SPA trials has been a significant improvement in this regard, but the FDA can still prove to be pretty rigid regarding products, like Oxytrex, that don't have the benefit of a SPA.