FDA issued a complete response letter to a Biologics License Application submitted by Telesta Therapeutics Inc. for MCNA. FDA said that additional phase III clinical trial for MCNA would be necessary to adequately establish MCNA’s efficacy and safety.
How’s this for a paradox: The better cancer centers become at keeping patients alive, the more expensive cancer care becomes. This brutal tradeoff hits harder in rural areas, where the cancer burden is higher and the investigator and clinical trial representation is lower.
