FDA's B Dunn

Discussion in 'BiogenIdec' started by anonymous, Nov 9, 2020 at 4:23 PM.

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  1. anonymous

    anonymous Guest

    Evercore’s Umer Raffat hinted that there might be another reason for Mr Dunn’s enthusiasm over adu. “There’s feedback going around some investors that he may be looking to leave FDA; he’s very incentivised to be supportive of [adu],” Mr Raffat said during his weekly investor podcast.
     

  2. anonymous

    anonymous Guest

    Very Fishy
     
  3. anonymous

    anonymous Guest

    All eyes will be on him so if he wanted approval because he is leaving the FDA that fact will come out. The argument that something should be approved because there isn't anything just doesn't hold water. There have been many patients that clearly did not benefit at all in the studies and that is an incredible disappointment and an all-time low to these poor individuals. To financially burden Medicare can't be justified with such little efficacy.
     
  4. anonymous

    anonymous Guest


    The vote sets FDA drug reviewer Billy Dunn, who clearly voiced support for Biogen's drug during the meeting, against the panel. If the FDA bucks the opinions of its advisers, its reputation for data-driven decision-making could be damaged at a time in which the agency's credibility with the public is as important as ever: Critical regulatory decisions for experimental coronavirus vaccines and treatments are likely to come soon.
     
  5. anonymous

    anonymous Guest

  6. anonymous

    anonymous Guest

    Billy Dunn is now under the microscope. The Advisory Committee's recommendation should not be ignored.
     
  7. anonymous

    anonymous Guest

    Yes seems like he was planning to leave the FDA. The media is looking at this very closely.
     
  8. anonymous

    anonymous Guest

    Doubt it gets approved now because
    of the scrutiny, unless the final
    data is overwhelming positive.
     
  9. anonymous

    anonymous Guest

    What is this guy's relationship with Biogen? He appears to be too close to Biogen and seems determined to approve regardless of what the panel said. Some have said the FDA had already made the decision to approve aducanumab prior to the advisory committee. That the advisory committee was just for show and appearances sake where they were going to approve regardless what the panel said.

    Approving this drug that has not shown the ability to repeat the efficacy results in a second study will hurt other drugs coming to market.
     
  10. anonymous

    anonymous Guest

    Please “B Dunn” with this joke of a drug, already.
     
  11. anonymous

    anonymous Guest

    They say he is going to approve no matter what and already made that decision before advisory committee. People will watch what he subsequently does. Leaving FDA and joining pharmaceutical industry.
     
  12. anonymous

    anonymous Guest

    I don’t see how pushing for drug approval would increase his pharma career prospects unless he gets a job at Biogen.
     
  13. anonymous

    anonymous Guest

    Good for him. The only problem is that he’s not the division director. Can you say overruled?
     
  14. anonymous

    anonymous Guest

    Yes but have you ever witnessed a time when the FDA released so many positive comments about ADU prior to the Advisory?
     
  15. anonymous

    anonymous Guest

    Will this drug get approved or require another study? I thought it was imperative to have two phase three trials that show efficacy. Otherwise, it just shows that any results if any were just random. Safety is a huge concern when there aren't two well controlled trials.
     
  16. anonymous

    anonymous Guest

  17. anonymous

    anonymous Guest

  18. anonymous

    anonymous Guest

    Just as everyone expected. There should be an investigation as to the relationship of Dunn. To be fair and ethical, more data must be developed before there is any kind of approval.
     
  19. anonymous

    anonymous Guest

    So is he being investigated and temporarily replaced within FDA?
     
  20. anonymous

    anonymous Guest

    Lmao. You're dreaming. Hell no he's not being investigated or replaced.