Avid Bioservices Inc (CDMO)

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>> perhaps not after a small compelling Open Label Phase I/II.


Unless the drug suddenly has SINGLE AGENT activity, probability is zero! FDA guidance on combination oncology drugs is clear, it needs randomized controlled trial against combination component(s). Two unapproved drugs like durvalumab in combination with tremelimumab for example need 3-arm trial for approval: durvalumab + tremelimumab vs durvalumab vs SOC even though primary endpoint is durvalumab + tremelimumab vs SOC, durvalumab monotherapy arm is needed for registration trial because contribution from components to combination need to be clearly characterized.