November 24, 2020 08:37 AM EST
Bioregnum
FDA+
Opinion

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eigh­teen days ago, vir­tu­al­ly all of the out­side ex­perts on an FDA ad­comm got to­geth­er to mug the agency’s Bil­ly Dunn and the Bio­gen …

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