ADU: Lose Lose, either way

Everyone wants to see this come to an end, regardless of the outcome. Adu will go down in history as the most controversial drug of the entire pharmaceutical industry. The pre-launch has been a nightmare and everyone knows this.
A.) In the event of unlikely approval - The indication will be so narrow and so unappealing that getting patients through will be near impossible making all adu positions miserable. Many have said it will become the worst job you will ever regret.
B.) In the event of denial with obvious request for 2nd phase 3 trial - Everyone will be displaced in a blink of an eye.

 

*eye roll* and the uneducated/outsider opinions continue to roll in... yes there's skepticism but my biggest customers have shown cautious optimism and hope. Two things you'll never find in a cafepharma post. Go home troll.

 

It is pure misery here. Won't be approved

 

Hi Pollyanna. Get your head out of the ground. Nothing has moved forward with a PI. What does that tell you?
It is ironic you are on here and spend time reading these threads. You truly are a piece of work. Have you ever heard the phrase "You're the pot calling the kettle black?" That is you! Unbelievable with your comments of "troll" as you troll the board. If you are super confident on approval, you wouldn't be spending time on this site. It is literally laughable.
Nothing has moved forward with the drug and indications of FDA requesting an appropriate second study are already coming forward. "Biggest customer have shown optimism and hope" is not factual. What is factual is the majority of communication from the medical community has come to a screeching halt.

 

A broad application of Adu would bankrupt American healthcare overnight.

 

When was the last time anyone in this industry has seen expert members from an FDA advisory board continue to push passionately for denial? Never. They published in the most respected journal JAMA. The writing is on the wall. Aducanumab through a lot of fine tuning and extrapolation shifted out a very marginal positive result in one study. This, as experts have explained, post hoc analyses are useful for generating interesting hypotheses to be tested in future trials, the post hoc analyses regarding aducanumab provided limited information useful in deciding the benefit of this new drug and these post hoc analyses should not be the basis for FDA approval. They sent a strong message not to diminish their conclusions.

 

has it ever occurred to any of you that those advisors are paid by Adu’s competitors?

Grow up.

 

This is a joke right? I have just starting reading this thread and cannot believe my eyes. What a moronic statement. Any competition would welcome an approval as it would make a path for their own approval. Yes, these experts in Alzheimer's, who are passionate about Alzheimer's, who have put their names on the line for all to see and be under a microscope, are paid off by a competitor pharmaceutical company. I guess it will be revealed they are all under the paycheck of XYZ pharmaceutical company and there will be this big conspiracy development. lol thank you for giving the entire world a laugh that there really are stupid people like you that exist in the world. Pathetic. Looks like you need to grow up.

 

Is it true that they haven't worked on the prescribing information? If so, that pretty much tells you it isn't going to happen. Probably for the best as the poor drug will have a suffocating REMS and beyond strict requirements to send any normal employee to the loony bin. Frankly, the odds never looked good for this agent. They should have taken a pass on the first attempt when you really look at the breath of data.

 

Heard that too
R.I.P.

 

Agreed

 

It is definitely a lose-lose considering all the time everyone has spent working on this project, but alas it isn't going to happen.

 

I can explain it to you but I can’t make you understand.

 

What? That you're an idiot? Or that we can't understand someone as dumb as you would have this job?

 

Does anyone think there will be any internal opportunities if adu is not approved?

 

Severance packages have already been created in case. Communication will be quick, following announcement. Some employees may be retained for pre approval work on Sage Therapeutics major depressive disorder opportunity, where data is expected 3rd/4th qtr this year.

From home office, things not looking good for aducanumab, surprising no one.

If you choose to be hopeful, consider a back-up plan.

 

Easy Chad! WE ARE WARRIORS!!!!

 

Yikes some of these last few minutes gives us all a feeling this drug is toast. I think I will still hold out before I start to look for a new opportunity.

 

Is this not going to happen? Everyone on my team thinks this isn't going to happen. It is very disturbing to hear that the package insert has not been worked on yet because many of us have rested in the fact that the label is going to be F#cked up and suck. This level of complexity would take months and months to properly develop a label with REMs involved. This alone would have been a challenge in of itself and made the working job very intolerable. Literally every recent article posted on the internet lately has been so negative and validating all reasons not to approve. HCP's are taking note of this too which really is unfortunate. If only the data would have been so much stronger.

 

Actually, they just finished the Package Insert. Under Warnings and Precautions it states “does not work, so not approved, enjoy your 2 weeks severance.”