The End­points News poll: Should the FDA pan­el back an ap­proval for ad­u­canum­ab, or should they send Bio­gen pack­ing?

There’s been a con­sid­er­able amount of back-and-forth over the rel­a­tive mer­its, or lack there­of, in Bio­gen’s ap­pli­ca­tion to mar­ket the Alzheimer’s drug ad­u­canum­ab.

Bio­gen ex­ecs have been ab­solute­ly stead­fast — at least af­ter their sec­ond take of the da­ta — that they’ve proven that a con­sis­tent high dose of their drug can mod­er­ate dis­ease pro­gres­sion. Crit­ics say it’s a post hoc mess filled with bias and blown so far off track that Bio­gen can’t come close to meet­ing the agency’s re­quire­ment of pos­i­tive da­ta from 2 well de­signed stud­ies.

Endpoints News

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