FDA Rejects NDA Filing

Discussion in 'Acorda Therapeutics' started by anonymous, Aug 29, 2017 at 8:26 AM.

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  1. anonymous

    anonymous Guest

    What an idiotic failure to execute a simple 505(b)(2) NDA!!!!!!

    Is "Leadership" collecting a bonus this year?

    SCOPIA where are you when we need you!
    They were so right; another company is better position to bring inhaled levodopa to Market.
     

  2. anonymous

    anonymous Guest

    Minor set back - a clear misunderstanding that will be easily resolved. Ron is tight with the Agency, highly unlikely that they will be anything but helpful and encouraging on our resubmission. Hey everybody hits a bump in the road now and then.
     
  3. anonymous

    anonymous Guest

    Minor setback? Ampyra lost it's patent protection and IS going generic and now the FDA refuses to accept this new filing. Time to start looking for a new job folks this company will be sold (if anyone will buy it) and you may or may not have a job. Ron may not even survive this one.
     
  4. anonymous

    anonymous Guest

    Really?

    Yes, let's have RC call Bastings and see how that goes?
     
  5. anonymous

    anonymous Guest

    .... and now the end is near
     
  6. anonymous

    anonymous Guest

    You are a complete imbecile.

    This is only a minor setback for Merck, BMS, JNJ or NVS who have multiple revenue streams.

    For Acorda, this is a BIG F-up. You didn't know you had manufacturing deficiencies? You hoped they wouldn't be called out? Somebody needs to be fired over this.

    As far as Ron having any better relationship with the FDA than any other CEO, keep smoking your ANTIFA cigs, because it sure as hell doesn't look like it at the moment honeybunch!

    Now that you are being sued by multiple investment groups, you might want to beg the CP monitor to scrub your BS PR posts because if they can prove Ron is having this crap put out there when it is misleading, it will be piled onto the misleading investor calls and bank communications.

    Face it--Acorda is screwed!
     
  7. anonymous

    anonymous Guest

    Total incompetence on the part of CMC, Regulatory and Project Management - the bucket of SH#T obviously stops with the CEO.
    Lucky for him the BoD has a soft spot for their good friend. But, that might not be the case for Rick, Tom, Sue and Burhardt.
    This would not have happened under the leadership of Brian Walter and Bonnie Pappacena: that NDA would have been FLAWLESS.

    Sad events. Very SAD!

    FIX THIS !!!!!!!!!!!!
     
  8. anonymous

    anonymous Guest

    Whoever writes anything positive above this is a liar and a moron. This is a complete debacle and a disgrace and shows poor execution. This company will now be forced to sell its assets and the board of directors will force a sale!
     
  9. anonymous

    anonymous Guest

    Friends please channel your anger in to finding a path forward. This is our company, Ron has always had our back through good time and bad. Now its our time to have his back and work through our set back. Together Each Achieves More TEAM
     
  10. anonymous

    anonymous Guest

    Well Said ! No Time For Excuses Or Whiners !
     
  11. anonymous

    anonymous Guest

    Enough of your rah rah bullshit.

    I don't want to hear another word from you until you show results.

    You are an idiot, delusional or both. Now STFU!
     
  12. anonymous

    anonymous Guest

    Like the press release that came out from Acorda HQ ? It had plenty of excuses for a major failure to execute on a simple 505(b)(2) NDA on well known levodopa.

    Recognize, own and fix quickly your mistakes; very costly to both patients and investors alike. Neither group is happy.

    If it was up to me, I would have Scopia take over and appoint a new management team that is capable of getting this NDA done without anymore glitches.
     
  13. anonymous

    anonymous Guest


    Here is fact and consider it truth:
    1. ACOR will not survive.
    2. Investors are tired and have no faith
    3. Law firms are already looking for shareholders to sue company
    4. Poor decisions
    5. Nepotism - yes guess from who and she hires shitty people from her crap past and now we are stuck
    6.The field will have deep cuts end year
    7. decisions will be made to cut CVT or sell company assts
    8. truth not being told about other reasons FDA will not move foreard
    9. No faith in our company by Wall Street or investors
    10. The industry laughs at us
    11> More of a voluntary exodus coming to join the many that already departed
    12. The BOD will roll heads on this one and demand a restructure and firings. MANY to blame. Poor decisions in medical, regulatory, manufacturing and commercial.
    13. RUN FOREST RUN!
     
  14. anonymous

    anonymous Guest

    Hi! There is a huge disconnect between Chelsea and Ardsley and it is SHOWING!
     
  15. anonymous

    anonymous Guest

    I am from a different pharma company and coming to your page in light of the recent NDA rejection to share something. How stupid can you be to screw up a 505b2 on levodopa?!?!?! Your company has been the laughing stock of mine this week. Never have we felt better to be where we are, than to be at a company who can't file a freaking levodopa 505b2!!! Isn't this the only product you have going on? Get your shit together. And by the way, since you will all be looking for jobs in a couple months, stay away from a Northern NJ based company because we do not want stupid incompetence here. I don't know too much about Acorda, besides what colleagues say who knew the people there. Two words frequently used: arrogant and narcissistic.
     
  16. anonymous

    anonymous Guest

    yikes!
    you killed it!

    arrogance and narcissism are not good traits for neither POTUS nor a CEO

    unfortunate set of events, indeed

    more unfortunate that the company has not given much information to its shareholder other than the usual "request a Type A Meeting"; makes one wonder whether in addition to the amateur mistakes whether they have a (or any) strategy to deal swiftly with the situation

    we at Sunovion are celebrating!!!!
     
  17. anonymous

    anonymous Guest

    Add narcissistic and liar. Poor legal and regulatory. Poor commercial and medical!
    We will be bought. Heard hands are being slapped and BOD is demanding a sale of assets. No one wants to buy the low grade company as the people cannot execute.