So once and for all, is this crappy drug getting approved?

How the hell did you even get this job? It's VERY widely known, and accessible, that the PDUFA date is March 7th. I don't even know why sales still exists. Good god.

 

Bunch of pathetic bastards. Lol

 

Maybe they were the only ones left after you killed everybody else with covid.

 

And? What does that prove and where did you get your information? The drug should not get approved. The efficacy data is embarrassing and they should go with the advisory committee. So...

 

Move on. Maybe you can land another job soon and not be so bitter.

 

FDA wouldn't be discussing label without the intent to approve.

 

Where are you getting this information? I heard absolutely no

 

Read the news. Samantha recently made comments that indicated they were discussing the label. If you heard absolutely no from anyone in sales or marketing, you shouldn't listen to them. Sales and marketing don't know what they are talking about.

 

Really? This is what you guys are talking about? Marketing can talk all they want about a label but it still doesn't mean there is going to be an approval. Wow people are so stupid. Approval would be a complete disaster for the whole system on something that does absolutely nothing.

 

Agreed! People just want to hear what they want to hear

 

Or people want to keep posting the same things from their moms basement. Get a life/job loser!

 

So...Are you into milking?

 

Funny coming from someone that clearly reads and posts on this thread relentlessly. Don't you have a life? Apparently not.

 

You really are a dufus. Are you saying you are not on here “relentlessly” and you don’t post the same redundant crap over and over???. Lmfao

 

He forgets, ADU didn’t work for him either

 

Why do people on here think it is the same people???? I know plenty of people that think it is a go, but at the same time plenty that think it is a no go. Who cares what the AA says or didn't say. It is a 50/50 shot. No one knows more than that. No one.

 

Dude I am not a hater just a realist, it’s 75/25 against at best right now. Even if approved the label will be so restrictive allowing managed care to not cover its a death sentence either way!

 

Well the Alzheimer's Association made sure they got a dedicated day with the FDA and arfe determined to get it approved regardless of the efficacy or lack thereof

This message is sent to all Alzheimer's Association and Alzheimer's Impact Movement board members, all Alzheimer's Association staff, and volunteers and supporters of AIM and the Alzheimer's Association.
Last week, the Food and Drug Administration (FDA) heard the heart-wrenching personal stories of individuals whose lives have been devastated by Alzheimer’s disease.
The Alzheimer’s Association worked directly with the FDA to arrange this session as part of our advocacy for new treatments. We were deeply concerned that the voices of those diagnosed with Alzheimer’s and their caregivers had not truly been heard during a recent advisory committee meeting on aducanumab, an Alzheimer’s treatment developed by Biogen, now under review by the FDA.
On behalf of the millions of Americans facing Alzheimer’s every day, the speakers candidly and powerfully used their voices to communicate the immediate need for treatment to FDA leaders. We are deeply grateful to each of the speakers, who so openly, and often emotionally, talked about the crushing impact of Alzheimer’s on their own lives and the lives of their loved ones.
Hearing the staggering realities of living with Alzheimer’s, with no treatment available for its underlying cause, the FDA participants were certainly engaged and expressed their appreciation for the speakers’ openness and honesty.
I told the FDA leaders that the Alzheimer’s Association, as a science-driven organization, continues to believe what we have told them previously, that aducanamab should be approved.
If approved, it would be the first treatment to potentially change the progression of Alzheimer’s, not just the symptoms. We believe the accumulated science, the publicly released data on aducanumab and the absence of any other treatment addressing the cause of the disease justifies FDA approval, accompanied by a Phase 4 post marketing surveillance study.
Be assured, we will keep working on this on behalf of the millions affected by Alzheimer’s until a decision is made. And then, whatever the decision, we’ll continue to work relentlessly until we realize our vision of a world without Alzheimer’s.
I will share more news with you when the FDA makes its final decision. As always, thank you for everything you do to advance our mission to make a difference for others — today and tomorrow.
Harry Johns
Chief Executive Officer

 

This association doesn’t have to deal with the attorneys that are lined waiting for an approval and the lawsuits will cripple Biogen if approved