Anavex Life Sciences Corp (AVXL)

[nidan7500]

Thx...BUT, we should note the AXX covering text from the PR. This is code for a very sloppy process review was conducted...(NOTE: N.J. IS home base for BP in USA.)

The FDA, in a statement, said the “decision to approve Aduhelm was based on our scientific evaluation of the data contained in the application, which is described in the approval materials.”

Biogen, in a statement, said it “stands by the integrity of the actions we have taken.”

FDA process findings: The committees’ review of the FDA’s and Biogen’s interactions over nearly two years found that an internal agency review concluded that the FDA’s work on a briefing document with the drugmaker ahead of a November 2020 advisory committee meeting “was not an appropriate approach” given the lack of consensus within the Office of New Drugs on the regulator’s position. Advisers overwhelmingly voted against recommending Aduhelm’s approval.

Committee staff obtained documents showing that FDA staff and Biogen officials held at least 115 meetings, calls and “substantive email exchanges” from July 2019 through July 2020. The agency acknowledged that the total number of meetings in that timeframe is unknown because the FDA lacked a “clear record” of informal interactions between regulators and the drug sponsor.

The FDA in its statement pointed to an internal review that found the actions were appropriate, and said the agency has already started implementing changes consistent with the committee’s recommendations, including examining the use of a joint briefing document.
“While we all support the search for new cures and treatments to address devastating diseases like Alzheimer’s, we must ensure that expediency does not take precedence over protocols that ensure the independence and scientific rigor of FDA,” Energy and Commerce Chair Frank Pallone (D-N.J.) said in a statement.


The FDA, in a statement, said the “decision to approve Aduhelm was based on our scientific evaluation of the data contained in the application, which is described in the approval materials.”

Biogen, in a statement, said it “stands by the integrity of the actions we have taken.”