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

    Well, strike number 2++++ for the CEO, Mike Derkacz. His incompetence leads to another delay and and yet another round of layoff's for Braeburn. He has fired more hard working, dedicated and stellar people in a year and a half than he has has generated a single dollar of revenue. But we are sure he and all the VP's will be fine with their golden parachutes and year long severance.

    Meanwhile, if you got what we got a year ago, plan on being unemployed with maybe a month of severance. That's what he did to us. This jackass walked around the office with an unprecedented arrogance, calling out other people for everything they do wrong that doesn't meet his ridiculous expectations, yet the result is the same, and he continues to fail the employees and the patients fighting this awful disease. He is the sole person responsible for this outcome and the sole reason why those of us who did all the work the way it should have been done, got screwed.

    So who is the real problem Mike Derkacz? Not anyone but you because leadership starts at the top, although we know you don't think your shit smells, we can see how you have no regard for anyone who did the work required and got fired, yet you still have a job. Meanwhile, our families suffer because of your incompetence. So glad he brought in all of his own folks. They will still all have a job. The rest that didn't lick his balls will be gone. Just shows the pure incompetence mentioned above. He cares more about himself than anyone who works their ass off for him. He could not care less about anyone but himself, and those few buddies he has hired. They will stay employed while anyone who is not his pet is let go, irregardless of how well they did their job to bring this lifesaving product to market.

    The thing that sucks is he has such little empathy for anyone that works for Braeburn, unless you are one of his pets, that he doesn't give a shit about you or your family.

    All he cares about is himself, and only himself. What an ego for someone who continually fails to launch products here or at Teva successfully. What a dick. I have never had the misfortune to work for such an incompetent, self-serving, narcissistic dick who thinks he knows everything, but results prove the opposite.

    Merry Christmas you Son of a Bitch. We hope someday, someone, somewhere will take your livelihood away from you and your family with the utter disregard for humanity that we experienced during our time at Braeburn.

    We hope you will pay someday for your treatment of the fine folks who made and make up the Braeburn team. Somebody on the board needs to realize Paul Johnson is the only reason most people stayed after we got let go. He is the only competent person on the executive leadership team. There was only one person who seemed to actually have empathy and care for people, Paul. Not Tom, not David, no-one in market access, not any of the executive team. Great job folks. I hope your Christmas sucks just as badly as the folks who know they are getting fired on Wednesday, and only because Mike is such an arrogant jackass and thinks he is so much smarter than everyone else, yet his track record is the opposite. I sincerely hope that any other company that researches Mike Derkacz, CEO of Braeburn, for future employment reads this post. It is 100% accurate, and don't even get me started on how out of bounds he is on compliance. He cares so little that he is willing to put every person that would have been in field as a target for the FDA. He is one of the most, if not the most, non-compliant senior executive to work in this field. If I were one of you about to get the pink slip, I would run to a lawyer and the FDA and DOJ and describe all the shady shit he is trying to pull over the agencys' eyes. That's probably why you didn't get approved AGAIN!!! Jackass with no feelings for anyone but himself and the arrogance and low EQ to not even know it. How sad for all the good people that worked so hard. If it wasn't for Mike, this would not have been a problem!!!!

    Good luck to those of you about to get the boot. There are way better people and companies to work for than one led by Mike Derkacz. I am having a blast working for competent management that takes into account what the people and their expertise is actually valued, instead of being looked down upon as peon's. Go fuck yourself Mike. Have fun with all your money while the rest of your poor team deals with unemployment due to your incompetence!!! Ho, Ho, Ho you evil bastard
     
  15. anonymous

    anonymous Guest

    Well, strike number 2++++ for the CEO, Mike Derkacz. His incompetence leads to another delay and and yet another round of layoff's for Braeburn. He has fired more hard working, dedicated and stellar people in a year and a half than he has has generated a single dollar of revenue. But we am sure he and all the VP's will be fine with their golden parachutes and year long severance.

    Meanwhile, if you got what we got a year ago, plan on being unemployed with maybe a month of severance. That's what he did to us. This jackass walked around the office with an unprecedented arrogance, calling out other people for everything they do wrong that doesn't meet his ridiculous expectations, yet the result is the same, and he continues to fail the employees and the patients fighting this awful disease. He is the sole person responsible for this outcome and the sole reason why those of us who did all the work the way it should have been done, got screwed.

    So who is the real problem Mike Derkacz? Not anyone but you because leadership starts at the top, although we know you don't think your shit smells, we can see how you have no regard for anyone who did the work required and got fired, yet you still have a job. Meanwhile, our families suffer because of your incompetence. So glad he brought in all of his own folks. They will still all have a job. The rest that didn't lick his balls will be gone. Just shows the pure incompetence mentioned above. He cares more about himself than anyone who works their ass off for him. He could not care less about anyone but himself, and those few buddies he has hired. They will stay employed while he anyone who is not his pet is let go, irregardless of how well they did their job to bring this lifesaving product to market.

    The thing that sucks is he has such little empathy for anyone that works for Braeburn, unless you are one of his pets, that he doesn't give a shit about you or your family.

    All he cares about is himself, and only himself. What an ego for someone who continually fails to launch products here or at Teva successfully. What a dick. I have never had the misfortune to work for such an incompetent, self-serving, narcissistic dick who thinks he knows everything, but results prove the opposite.

    Merry Christmas you Son of a Bitch. We hope someday, someone, somewhere will take your livelihood away from you and your family with the utter disregard for humanity that we experienced during my time at Braeburn.

    We hope you will pay someday for your treatment of the fine folks who made and make up the Braeburn team. Somebody on the board needs to realize Paul is the only reason most people stayed after we got let go. He is the only competent person on the executive leadership team. And Paul seemed to actually have empathy and care for people. Not David, Not Tom, not any of the executive team. Great job folks. I hope your Christmas sucks just as badly as the folks who know they are getting fired on Wednesday, and only because Mike is such an arrogant jackass and thinks he is so much smarter than everyone else, yet his track record is the opposite. I sincerely hope that any other company that researches Mike Derkacz, CEO of Braeburn, or future employment reads this post. It is 100% accurate, and don't even get me started on how out of bounds he is on compliance. He cares so little that he is willing to put every person that would have been in field as a target for the FDA and DOJ. He is one of the most, if not the most, non-compliant senior executives to work in this field. If I were one of you about to get the pink slip, I would run to a lawyer and the FDA and DOJ and describe all the shady shit he is trying to pull over the agencys' eyes. That's probably why you didn't get approved AGAIN!!! Jackass will make a million dollars this year and next, all the while firing the rest of you. What a sad, pathetic little man with little man syndrome. I hope you are proud of yourself. Tearing people's live apart, all because of you arrogance and incompetence. How in the hell did you not see this coming?
     
  16. anonymous

    anonymous Guest

    Can still launch the weekly. Don’t think patients want a weekly injection though.
     
  17. 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.
     
  18. 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.
     
  19. anonymous

    anonymous Guest

    Can still do the weekly
     
  20. anonymous

    anonymous Guest

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