NorthWest Biotherapeutics Inc (NWBO)

[Truthfan]

Of interest to those following this FDA story on Biogen/Eisai’s recent drug approval:

Public Citizen calls for removal of senior FDA officials in wake of Aduhelm approval


https://www.firstwordpharma.com/node/1838171?tsid=28®ion_id=6


“Public Citizen on Wednesday called for the resignation or removal of three of the FDA's most senior officials in the wake of the agency's decision to grant accelerated approval to Biogen and Eisai's Aduhelm (aducanumab) for patients with Alzheimer's disease. The letter, sent to Xavier Becerra, Secretary of the US Department of Health and Human Services, branded the move "indefensible" and said it "showed a stunning disregard for science."
In the letter, Public Citizen asked for those most responsible for the FDA's decision on Aduhelm to resign or be removed, including Acting Commissioner Janet Woodcock, Center for Drug Evaluation and Research (CDER) director Patrizia Cavazzoni and CDER's office of neuroscience director Billy Dunn. The consumer advocacy organisation suggested that the "litany of flaws" in the regulator's review of the drug is lengthy, while the decision has "eviscerated the agency's standards for approving new drugs."
The letter concluded that Becerra "should direct the next Acting FDA Commissioner to consider whether the agency's approval of [Aduhelm] should be withdrawn."