The FDA does not backward license for a condition that is no longer scientifically defined in the manner originally intended. It’s not just words or language. The redefinition has real implications. If the drug were not efficacious for either of the newly defined conditions that came out of the process, that would be a problem. But an unsolvable problem and the result of a lack of effectiveness, and they’d have some choices to make to fix the situation or not.
I believe in this case, the opposite is the result, in terms of efficacious indications. But NWBO still needs to discuss the science, as it exists now, in the context of their trial results. They will be asked and that is an unfortunate reason why the FDA gives no guarantees on NDA approvals for the SAP or even why after they negotiate a special protocol assessment (SPA), it is still no guarantee that they won’t change their mind. Things change. They won’t be held to an outdated way of thinking just because someone ran a trial on that basis.
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