Guidance is GUIDANCE. You try to beat people up with narrow readings absent contrary evidence and context, and the guidance is not hard and fast and they themselves say so. They make exceptions all the time, where it makes sense and in rare diseases. But the reality is, they did prespecify, it just was not in a manner that would be done NOW typically, but as I just explained, in another post, your posts insisting on rules that are not rules, and requirements that are not hard and fast requirements, just blows smoke up everyone's rear ends. You harp on notions that have been fully addressed, just not practically possible at the time they started the trial but appropriately addressed in a manner likely worked out directly with regulators... You are not a regulator, and of course you can insist on rigidity, but that's not the reality of regulation in such contexts. The FDA is not going to make them start a P3 all over again, when there are reasonable ways to address the issue. I know it fits within the notion that some like to promote, that regulators are inflexibly stupid and impractically minded, but that's not typically true. But in order for shorts and Adam Feuerstein to "look like they know something", such viewpoints have to be CONSTANTLY reasserted and rehashed. I see Ada resurfaced as have you.
I own NWBO. My posts on iHub are always posted expressly as just my humble opinion (IMHO) and none are advice, just my opinion. I am NOT a financial advisor, and it is assumed that everyone is responsible for their own due diligence.
AI
