Unfortunately, DNDN data did not demonstrate actual survival.
I carefully reviewed DNDN data. The data is very weak. By approving DNDN's drug, FDA will undermine the drug approval process supposedly based on integrity and soundness of clinical data rather than on someone guesses or speculations.
Such FDA action will be doing great disservice to cancer patients offering them unsubstantiated hopes.
Your argument ought to be directed to Congress rather than the FDA. As mentioned in #43948, the writers of Subpart H/Subpart E did not anticipate that cancer drugs would initially be reviewed by the FDA based on survival data.
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