MSN published "an abridged version" with the same title: https://www.msn.com/en-us/news/us/inside-e2-80-98project-onyx-e2-80-99-how-biogen-used-an-fda-back-chan

MSN published "an abridged version" with the same title: https://www.msn.com/en-us/news/us/inside-e2-80-98project-onyx-e2-80-99-how-biogen-used-an-fda-back-channel-to-win-approval-of-its-polarizing-alzheimer-e2-80-99s-drug/ar-AALzzpL https://www.msn.com/en-us/news/us/inside-e2-80-98project-ony... Excerpts: > Central to their mission was an inside ally: Billy Dunn, the agency’s top regulator of Alzheimer’s drugs. For the plan to succeed, Biogen needed Dunn to become a supportive partner, more than an independent and potentially adversarial regulator. It worked. The FDA played an extraordinarily proactive role, even drafting a road map on how the company could win approval. Several experts said that relationship was not typical and raised serious concerns. > It was previously known that Biogen and the FDA worked together on Aduhelm. But STAT has learned that the relationship began earlier than previously disclosed, in the spring of 2019, when a top Biogen executive quietly met with Dunn — seemingly in violation of FDA protocols — to enlist his support for a long-shot effort to get Aduhelm approved despite the apparent failure of two clinical trials. And a month later, FDA officials proposed using a regulatory shortcut to get the drug approved — though the agency has claimed it raised that option only this past March. To some inside Biogen, the FDA’s tone made approval seem inevitable. > By June 2019, only a month after the crucial meeting with Dunn, agency officials in his Office of Neuroscience were so willing to advance Aduhelm that they proposed as one option a regulatory shortcut called “accelerated approval,” according to meeting minutes read to STAT. The move stunned even Biogen’s top executives, who had considered that out of the question for a host of reasons, including the fact that the FDA had never used the pathway for an Alzheimer’s treatment.