Neuro, Dr. Stoll said the histopathologists had never seen anything like the cellular changes caused by CX-717 (and the fact that they were caused by the drug and were not an artifact was confirmed by their dose dependent reappearance in the rat study). That may be why the FDA apparently didn't notice the cellular changes originally, before the Phase 2as - no one had seen anything like it before, so they weren't looking for it. What we really need to worry about now, along with everything else, is what a thorough tox reexamination of Org-24448 might reveal.
Unfortunately, one can now start to make an argument that Cortex may belong in the "broken biotech" portion of one's portfolio, ie - the seriously flawed companies. I don't know, to me this feels considerably worse than the Shire rejection of CX-516. CX-516 was merely a very weak compound, and everyone already knew that. The question now is whether there is a fatal class wide problem with the low impacts generally. Think I need a beer...