GAME OVER ADU

So you are saying there is a chance?? Yes!!!!! Approved!!

 

Absolutely no chance of approval

https://mkus3lurbh3lbztg254fzode-wpengine.netdna-ssl.com/wp-content/uploads/2575.pdf

April 1, 2021

The Honorable Xavier Becerra Secretary of Health and Human Services
U.S. Department of Health and Human Services
200 Independence Ave. SW Washington, D.C. 20201

RE: FDA approval of Biogen’s aducanumab for treatment of Alzheimer’s disease despite lack of evidence of effectiveness would provide false hope to millions of patients and pose an unacceptable threat to the financial health of the Medicare program

Dear Secretary Becerra: Public Citizen, a consumer advocacy organization with more than 500,000 members and supporters nationwide, is writing to call your attention to the alarming circumstance described in our December 9, 2020, letter sent to the Department of Health and Human Services (HHS) Office of Inspector General (OIG) (copy enclosed). We called on the OIG to immediately launch a formal investigation to scrutinize the unprecedented close collaboration between the Food and Drug Administration (FDA) and Biogen that occurred before and after the submission of Biogen’s biologics license application (BLA) for the new biologic drug aducanumab for treatment of Alzheimer’s disease. Such close collaboration — which was made fully transparent in press releases and presentation documents issued by Biogen and in the unprecedented joint briefing document prepared by the FDA and Biogen for the FDA’s Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee meeting on November 6, 2020 — dangerously compromised the independence and objectivity of senior staff and clinical reviewers in the agency’s Office of Neuroscience (ON) in the Center for Drug Evaluation and Research’s (CDER’s) Office of New Drugs during the agency’s review of Biogen’s BLA for aducanumab and key data from two identical pivotal phase 3 clinical trials of the drug. The unbridled enthusiasm of the FDA’s ON staff for aducanumab documented in the PCNS Drugs Advisory Committee meeting document jointly written by the FDA and Biogen and echoed in ON Director Billy Dunn’s presentation at the November 6, 2020, advisory committee meeting was not supported by an objective review of data from the pivotal phase 3 clinical trials, which had been terminated early after enrollment had reached only 50% of the planned target enrollment because a planned prespecified interim analysis showed the trials were unlikely to yield evidence that the drug was effective for treating Alzheimer’s disease. In a very brief, pro forma letter dated January 11, 2021, the OIG responded to Public Citizen’s December 9, 2020, letter and stated the following:

 

There is no chance. It won't be approved.

 

Only the most poorly informed and desperate took a job to sell this drug. There is one chest thumper on this board talking about how good and elite they are. Everyone else is ashamed and having difficult conversations with their family about how they might be out of a job.