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Latest News - ADU won't be approved

Discussion in 'BiogenIdec' started by anonymous, Oct 19, 2020 at 9:26 AM.

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  1. anonymous

    anonymous Guest

    Sure she did.
     

  2. anonymous

    anonymous Guest

    Truth!
     
  3. anonymous

    anonymous Guest

    Anyone who took a job here with the public knowledge of the failed pivotal AD trial showed a tremendous lack of judgement, initiative to research the company, or both.

    Big red flag when they are let go and try to interview for a new position.
     
  4. anonymous

    anonymous Guest

    If true, good for her. Cares about her reports, even if there is some risk of blow back by not sticking to the corporate line. People over company folks.
     
  5. anonymous

    anonymous Guest

    THIS.
     
  6. anonymous

    anonymous Guest

    I think it's going to get approved but have strict limitations. to mild/moderate ad. There's a clear benefit for some patients but does it out way the cost of med? That's the biggest question. Once you get this diagnosis it's not commercial patient anymore. patient will fall under Medicare. Federally funded just like FDA. The FDA will have to collaborate with Medicare and AARP. If priced out of line, could strain or bankrupt the whole system. But if you can prolong nursing home admission by 4-5 years. That could be a substantial amount of cost savings as well as patient living with independence.
    Why did RBC put together a mock committee? It's not coincidental they unloaded institutional shares prior to publishing that. So was there financial gains before October 31. YES
    I believe we made some sales/marketing moves that are unclear. Vumerity all day, all night. Forget about selling the portfolio. That I can't understand. It blows my mind we have Tysabri. One of the best drug onthe market.
     
  7. anonymous

    anonymous Guest

    Go Away. If you don't like to read these comments, then don't troll the board. It is that simple.
     
  8. anonymous

    anonymous Guest

    Biogen Bet on Alzheimer’s Drug Faces Poor Odds, Says UBS

    UBS now giving it a 5% likelihood of approval: A survey of regulatory experts by UBS concludes that FDA approval is unlikely, however, after two clinical trials of the drug reached two different results. Biogen declared one of them positive, only after initially declaring that trial negative. The positive revision relied on analysis that imputes values for data that is actually missing, says Bristow. He concludes that aducanumab’s chances for approval are just 5%.

    Net/net - The studies failed. Biogen (aka Michel) hoping for a moonshot to save his job as he has invested billions in these ALZ programs while deferring to use that capital in real BD / M&A. Think about all of the companies that Biogen could of purchased with commercial and/or commercial-ready assets to stave-off the generic erosion of the MS business (e.g. Avexis, Alexion, Sarepta, etc.).

    Oh...and don't forget the billions in stock buy-backs to keep the share price high so that the executives can line their pockets as they sell off their shares.
     
  9. anonymous

    anonymous Guest

    This x1000. Need to think of the big picture. If early AD patients can prolong independence even a bit it will have massive ripple effect of entire system and reduce cost burden. The data shows that with specific population at specific dose, the drug does work. It is clear as day. Will that balance out with cost of treatment? Up for debate, but 15 disgruntled reps on Cafepharma sure as hell aren't the best source to rely on.
     
  10. anonymous

    anonymous Guest

    CRL is best case scenario. The drug dies a quiet death after that.
     
  11. anonymous

    anonymous Guest

    5% chance for approval based on independent analysts - 95% chance if you are on the ADU team you will be fired shortly - don’t blame reps.
     
  12. anonymous

    anonymous Guest

    There is not a “clear benefit.” There would be if they predefined there would be a benefit in that study population and then powered the study to show it from the beginning. Finding a glimmer of something positive after the fact in a sub group means close to nothing, other than it’s a place to start for next phase 3 study.

    I’m not expecting you to understand statistics, but you have been sold a huge bill of goods when you took this job.
     
  13. anonymous

    anonymous Guest

    I don’t think that person saying there is a clear benefit is a sales Rep. There are a lot of people from R&D on cafepharma and I find they have a hard time separating reality from minor glimpses of hope in a tough research field. Most of R&D are a very delusional group of people that think any small insignificant positive sign in study data read outs = likely FDA approval + blockbuster potential. Trust me, I’m there and they think everything works and everything is the next best drug. I heard it for years about the recently cancelled Opincinumab and the pain drugs that can never get off the ground and running, and stroke and Tau And PSP and on and on...
     
  14. anonymous

    anonymous Guest

    So if the FDA accepts the filing, will you and others on here still be skeptical of the data?
     
  15. anonymous

    anonymous Guest

    From the guy who never got an interview because his resume was weak blahhahahaha
     
  16. anonymous

    anonymous Guest

    nope. If FDA accepts it I will accept. They have a legion of people going over it.

    lol good luck. Your. Pivotal. Failed.
     
  17. anonymous

    anonymous Guest

    Says the gal who was a 4th choice and soon to be fired but is still on here bragging about it - hahaha
     
  18. anonymous

    anonymous Guest

    This person has a clue. The Alzheimers financial burden on families and healthcare is projected to be over $1 trillion in the next 10 years without something on market. No drug is perfect.
     
  19. anonymous

    anonymous Guest

    You're, all, pharma reps. You chose to be a rep as a career. No one gives a damn about your decision making process.
     
  20. anonymous

    anonymous Guest

    Funny and true