Friday, November 06, 2020 7:18:25 PM
How important is today’s FDA 8-1 (2 uncertain) rejection of Aducanumab given the letter that the Alzheimer’s Association circulated on Biogen’s behalf?
What light does that put on the AA going forward? Now it’s understood where they stand on getting a treatment for this disease: they did not remain impartial in the affairs of the FDA but rather lobbied for a certain treatment which they felt would be promising and beneficial to treating this disease.
Personally, I was appalled that they took this giant, public, step on behalf of an unproven and dangerous drug candidate. This is not opinion given the 8-1 margin citing failure to show efficacy.
The AA has never given any accolades nor attention to Anavex’s efforts. They have not given our company funding to advance our drug. Perhaps, after today’s void in the field of AD from BP and our CTAD results from a trial which is largely indicative of carry over to Alzheimer’s Disease, as attested to by 10 world renowned experts in a live presentation at a well respected forum, the AA will recognize our efforts?
Personally, I lobbied the FDA at the rate of 5+ emails per day for past several weeks in an attempt to get objective facts in front of their eyes. I, and probably others, were relentless in our efforts to present every facet of Biogen’s trial’s shortcomings in reaching the threshold of safety and efficacy.
(Would be off topic to do the data dump on this board)
I have reached out to AA in the past regarding our drug’s promise. I would hope that they will now continue to work on helping AD patients via novel drugs which show greater safety and promise going forward.
If you support AA and have helped their mission in the past, please remain relentless in your efforts. They have set a precedent with Biogen’s drug which I think should benefit us down the road.
Work on all fronts to win. Thanks all,
Biostock
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