'Reg­u­la­to­ry flex­i­bil­i­ty is not war­rant­ed': FDA balks at al­low­ing Chi­na-on­ly da­ta for Eli Lil­ly's an­ti-PD-1 an­ti­body

Ahead of Thurs­day’s ODAC meet­ing for Eli Lil­ly’s an­ti-PD-1 sin­til­imab, FDA said that the Chi­na-based piv­otal tri­al on which the ap­pli­ca­tion is based “rais­es sig­nif­i­cant …

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