the reason why these idiots COULD NOT submit in the US is that the FDA does NOT offer guidelines for an ECA RWD (especially without IPD) based BLA. Why is that so difficult to understand for you? By all means, blame them for their greed, their long history of incompetence I all agree with that, but its as if you are oblivious of what medical trial you actually invested in. God all mighty. Its as if you are angry at a poodle for not being able to wrestle a cobra snake.
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