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EQRx Price Disruptor Business Model Faces The Costly Reality Of FDA Drug Development Standards

 
• By Cathy Kelly

Start-up firm, with two Chinese-developed drugs for lung cancer in late-stage development, may be particularly vulnerable to the US Food and Drug Administration’s recently stated opposition to the Chinese-only research supporting Eli Lilly’s sintilimab.

FDA Response To Lilly's Chinese-Only Studies Surprised Many In Industry • Source: Alamy

An innovative start-up company that aims to disrupt biopharma’s traditional pricing model with “radically” lower priced me-too drugs is facing potentially significant challenges from the US Food and Drug Administration right out of the gate.

The FDA's concerns over the fact that the pivotal clinical trial for Eli Lilly/Innovent's PD-1 inhibitor sintilimab was based primarily...

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