Much of that process does not apply to Kevetrin or Prurisol, if both work as expected. With excellent Phase 1 results, Kevetrin will qualify for unmet need against stage 4 highly resistant solid tumor cancers. At the least, it will jump from Phase 1 to Phase 3 since much of Phase 2 is already designed into the current trial. Best case, if Phase 1 results align with animal efficacy and tox studies, it will be designated a breakthrough therapy and immediately approved for clinical use and marketing against high resistance tumors, without further testing.
Prurisol is already entering Phase 2/3a testing in Europe, and with decent results there, should be approved for pivotal Phase 3 testing in the US. So, both drugs are farther advanced in the human testing process than the FDA "Drug Review Process" would indicate.
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