An MHLW panel held on 8 Feb discussed approval in Japan based solely on foreign clinical data in some exceptional cases. MHLW has proposed specific conditions: 1) Pivotal clinical trials have already been already conducted outside Japan, 2) If additional clinical trials in Japan would not be feasible due to very small numbers of patients, and 3) Efficacy and safety data indicates that benefits would outweigh risks in Japanese patients. Please watch the space!
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