Usually reserved for unmet medical need or when new drug is a major improvement over SOC ( standard of care )
Fast track enables an FDA rolling review of clinical data , more FDA meetings , faster FDA review ....think development of drugs to treat AIDS
CCX168 is an improvement over the existing steroids currently used by Kidney disease patients.
Many patients complain of the side effects ...mood swings , puffy face etc so CCX168 would enhance patient compliance
Not sure it would qualify for Fast Track but if it did it would certainly speed up the time line to FDA approval ( assuming good P 3 results .
JMO
Kiwi
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