The FDA could indeed care less about the financial realities for the companies that make innovation possible (if charity and government funding were the only funding then very little could happen). This is true.
The fact that patients die horribly and have no other hope and are dead anyway the fact that the phase 1 portion did address the safety issue and the fact that plenty of other safety data exists from UCLA puts the safety issue to bed and makes approving DCVax-L the utilitarian thing to do.
The political backlash from rejecting DCVax-L will be much greater than approving it, especially given that this is a dread disease that kills quickly.
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