The single only reason for approval - and it isn't enough

Discussion in 'BiogenIdec' started by anonymous, Apr 19, 2021 at 11:57 AM.

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  1. anonymous

    anonymous Guest

    The FDA may look at all the options and conclude that with no breakthrough progress having been made in any therapeutic approach other than the targeting of amyloid beta and misfolded tau, it is time to open up the treatment to the public, and the market to the pharmaceutical industry, given its (just about) demonstrated ability to slow decline of Alzheimer's.

    Unfortunately, this just isn't enough to have a drug approval and for the wrong reasons. The enormous lack of efficacy data is clear.

    FDA will ask for an additional phase 3 study that Biogen will refuse to do. FDA usually does the right thing and in this case, should require the additional study.

     

  2. anonymous

    anonymous Guest

    There really is no other reason. The data is flat and obviously cherry-picked. The FDA knows this.
     
  3. anonymous

    anonymous Guest

    Dude go find a woman to pass your time. You seem to have way to much time to waste.
     
  4. anonymous

    anonymous Guest

    You are going to make a statement to them like that? Really? LOL thanks for giving us all a great laugh. You are on here taking time during the day reading posts and even just left a post. GO AWAY YOU COMPLETE JOKE! Thanks "Dude."
     
  5. anonymous

    anonymous Guest

    This is likely never getting approved the data is horrible. On top of that if it did somehow get approved we will try to price it at a premium but then based on the lack of efficacy insurance will never pay for it.

    Its about as good as placebo. That said after watching the government pander to Covid vaccine makers nothing will surprise me.
     
  6. anonymous

    anonymous Guest

    Dude you writing an emotionally charged novel on here filled with your personal opinion shows you are a waste of space. Nobody cares. Now go get lucky if you can. Hell pay for some if you must. Hahahahaha......
     
  7. anonymous

    anonymous Guest

    Wow there are some very immature people on here. They just posted an interview with FDA Commissioner Janet Woodstock and they are inundated with covid issues. This is one point they made:

    Question: Will new centers of excellence for neuroscience and rare diseases be beneficial or redundant to existing centers?

    JW: We are exploring the possibility of other centers of excellence, but the Agency is under so much stress now… Adding new centers could take a few years to put in place, and then you have to socialize them so everyone knows how to work with those systems. We have a wall of work in front of us, so we are avoiding disrupting things right now.

    Question: There’s a perception that some drug reviews are being delayed, some accelerated approvals are receiving a second look, and flexibility is inconsistent regarding clinical trial evidence. Is the FDA taking a more stringent approach to reviews?

    JW: I don’t think so. What’s happening is that science is moving drug development into fields that typically haven’t seen advances like we’ve seen in cancer, so some adjustments must be made.
     
  8. anonymous

    anonymous Guest


    LOL that's EASY. WSJ - Opinion. Won't even list an author! Completely biased and states FDA's Woodcock was criticized for going against Advisory Committee twice and they were positive. That is WRONG and they ended in disasters. No mention of complete lack of data. Opinion articles are rubbish and complete garbage and hold no weight. Enough for you?
     
  9. anonymous

    anonymous Guest

  10. anonymous

    anonymous Guest

    hey dumb: the by line is the Ed Board.




     
  11. anonymous

    anonymous Guest

  12. anonymous

    anonymous Guest

    So Agree! I find 'Opinion" articles so pathetic. The reputation of the WSJ just took a tumble. Shame on them. This was simply an advertisement piece. Disgusting how they try to post this as news. Completely biased. ADU won't be approved.
     
  13. anonymous

    anonymous Guest

    thank you, CEO of nowhere!


     
  14. anonymous

    anonymous Guest


    Keep drinking that Kool Aid and hiding your head under a bushel. Good for you! I say keep doing what you are doing, don't provide yourself with safety net, and wait till Biogen comes to you!