1. Gilead’s Kite files for FDA approval of second CAR-T — Merck’s Keytruda gets win for triple-negative breast cancer — The House votes on the Lower Drug Cost Now Act — See more on our front page news

    TRY TWO WEEKS OF OUR EMAIL NEWS HEADLINES FOR FREE
    Dismiss Notice
  2. Think you have witnessed fraud?Ask a Whistleblower Attorney -- a chance to discuss whistleblower-related legal issues with practicing whistleblower attorneys.
    Dismiss Notice

Deficiencies are minor.

Discussion in 'TherapeuticsMD' started by anonymous, Apr 20, 2017 at 6:46 PM.

Tags: Add Tags
  1. anonymous

    anonymous Guest

    Apparently the deficiencies will be corrected before a May 7th. Marketing hasn't stopped as recruiting picks up for Q1 18.
     

  2. anonymous

    anonymous Guest

    The deficiencies are NOT minor. I'm in the home office and there is a lot talk about this product not getting approved at all. Senior leadership people are freaking out.
     
  3. anonymous

    anonymous Guest

    I'm in the home office too, hearing many similar stories.
     
  4. anonymous

    anonymous Guest

    Lies. You're at the home office yet upper mng freaking out? You sound like a scared short. see the 7.5 call options today? . Sales force is packed for approval and launch 1q 18. Have fun living in a tool shed.
     
  5. anonymous

    anonymous Guest

    Can confirm, they received a response from the FDA and will PR this Wend pm. I dont know what the deficiencies were, but I'm told May 7th is still the pdufa date as far as they know.
     
  6. anonymous

    anonymous Guest

    Told you, check zip recruiter.
     
  7. anonymous

    anonymous Guest

    PR this afternoon. Enjoy folks.