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Not Allowed to Market in US!

Discussion in 'Braeburn Pharmaceuticals' started by anonymous, Dec 23, 2018 at 3:25 PM.

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  1. anonymous

    anonymous Guest

    From FDA: Not allowed to market in the US??? So we are all out of a job?? WTH
     

  2. anonymous

    anonymous Guest

    Why?
     
  3. anonymous

    anonymous Guest

    Indivior lawyers grasping at straws again...


    "With the tentative approval, Brixadi has met all regulatory standards of clinical and non-clinical safety, efficacy and quality for US approval. However, final approval of a monthly depot is according to the FDA subject to the expiration of an exclusivity period granted to Sublocade™. The restriction period may not last longer than November 2020, but both the scope and duration could be reduced if successfully challenged.
     
  4. anonymous

    anonymous Guest

    This sucks. How could the company Not see this coming??
     
  5. anonymous

    anonymous Guest

    Indivior has been granted exclusivity by the FDA for their once-monthly injectable. exclusivity not to exceed 11/2020. However, Braeburn could challenge and possibly shorten the timeframe.
     
  6. anonymous

    anonymous Guest

    Maybe they will challenge and if not successful, go forward with launching the weekly.
     
  7. anonymous

    anonymous Guest

    These patients dont want a freakin shot every week!
     
  8. anonymous

    anonymous Guest

    Second time trying to launch this damn thing. So new hires get sent home again?? For the second time??
     
  9. anonymous

    anonymous Guest

    Doesn’t say we can launch the monthly?
     
  10. anonymous

    anonymous Guest

    I don’t understand how this was never looked at as an obstacle moving forward.
     
  11. anonymous

    anonymous Guest

    FDA's tentative approval of a drug product is based on information available to FDA at the time of the tentative approval letter (i.e., information in the ANDA and the status of current good manufacturing practices of the facilities used in the manufacturing and testing of the drug product) and is therefore subject to change on the basis of new information that may come to FDA's attention. A new drug product may not be marketed until the date of approval.
     
  12. anonymous

    anonymous Guest

    It actually says cant launch a depot period. Says nothing about monthly or weekly.
     
  13. anonymous

    anonymous Guest

    They’ll challenge and win!
     
  14. anonymous

    anonymous Guest

    This thing is dead in the water. No way in hell this patient type would even go for a weekly injection let alone treatment beyond that. It is hard enough getting these patients in for treatment when there are so many other highs they can get on the street for less money. There is also another factor that goes with approval for this product. Patients will have to show up for weekly counseling and addiction therapy by an approved addiction specialist. Good luck with that when most of these patients will be impossible to get to those counseling sessions.
     
  15. anonymous

    anonymous Guest

    Challenge and Win? How in the world can we challenge and win this. It will cost 100's of thousands of dollars to challenge this and if I'm not mistaking, we are still being funded by a group of investors or hedge fund. Have you looked at the stock market lately? There isn't revenue rolling in right now and who will pay for these court costs? Commercialization of this product is what the investors are banking on to start bringing in capital. Mark my word, these investors will start to bail. Time to cut the losses.
     
  16. anonymous

    anonymous Guest

    Can still do the weekly
     
  17. anonymous

    anonymous Guest

    Camurus has $$. They’ve got skin in the game just like us.
     
  18. anonymous

    anonymous Guest


    Weekly???? Good luck with that. Half of this patient population don't want the help and those that do will have to rely on caregiver services or that of a gov't / outreach organization to get them to a treating physician on a weekly basis. How long will that last? Those in long term treatment centers won't be able to afford or are already on less expensive treatment options.
     
  19. anonymous

    anonymous Guest

    What now?
     
  20. anonymous

    anonymous Guest

    You’re never gonna get a patient into the office for a weekly injection. Good luck.