Just read CELG's C transcript, and they blatantly avoided answering a question about whether they needed to do a a two-year carcinogenicity study in animals for ozanimod - they claimed resubmission of NDA expected in Q1/19, but didn't explain how they're going to achieve it. They have a big problem on their hands in my view - the metabolite that's the problem is only created in humans, not animals - so to fully test it to meet FDA's concerns they'll have to synthesize the metabolite, if that's even possible - might be more difficult than they think.
These kinds of problems with man-made chemical drugs is one reason why V is such a wonderful drug - made by nature, safe as hell, no hidden problems lurking underneath the surface - and I'll bet someday high dose EPA will be shown to have cancer protective properties as well (instead of possibly causing cancer like ozanimod).
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