Upcoming FDA Panel: Will It Pass?

Discussion in 'Chelsea Therapeutics' started by Anonymous, Jan 12, 2014 at 11:24 PM.

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  1. Anonymous

    Anonymous Guest

    Is this another useless run or will Chelsea be told for the last time, NO Thank you!

    Any thoughts.
     

  2. Anonymous

    Anonymous Guest

    16-1
     
  3. Anonymous

    Anonymous Guest

    Approved :)
     
  4. Anonymous

    Anonymous Guest

    Will FDA approve it in February?
     
  5. Anonymous

    Anonymous Guest

    It already was approved.
     
  6. Anonymous

    Anonymous Guest

    No, that was the advisory panel. They recommended it the last time and the FDA rejected it. Will the FDA allow the patient testimony that was given at the advisory meeting to be included?

    With a 16 to 1 vote does this look like a lock?
     
  7. Anonymous

    Anonymous Guest

    I don't know - I"ve heard its pretty much 50/50 and if they don't get approval shares will plummet. Also, Chelsea doesn't have that much cash in the bank.
     
  8. Anonymous

    Anonymous Guest

    is co recruiting for sales force or waiting first for approval with fda?
     
  9. Anonymous

    Anonymous Guest

    Waiting for approval first, then they are going to hire a contract sales force for launch.
     
  10. Anonymous

    Anonymous Guest

    they are also hoping for approval with the idea of having some of the big pharma companies bidding up the stock price for a takeover
     
  11. Anonymous

    Anonymous Guest

    Maybe, I hope my company buys this product. I hate that they are going contract because I would take a shot if the company was hiring directly.
     
  12. Anonymous

    Anonymous Guest

    Read up on lemtrada. Committe suggested approval yet the FDA gave it a complete response letter. A yes from the committee does not equate to an approval
     
  13. Anonymous

    Anonymous Guest

    Stock is down today so someone must know that the word from the FDA is no go.
     
  14. Anonymous

    Anonymous Guest

    Congrats!
     
  15. Anonymous

    Anonymous Guest

    Now how long will it take for another company to make bid for purchase?
     
  16. Anonymous

    Anonymous Guest

    The first time around they were going after the top reps. If they ultimately went with a contract sales force, it would be a terrible launch
     
  17. Anonymous

    Anonymous Guest

    The CEO said they were going contract if the drug got approved. Pretty smart by the company because being a top rep in Pharma is a myth, if the products meets an unmet need and insurance will pay for it docs will write if not they want.
     
  18. Anonymous

    Anonymous Guest

    completely agree. Especially in today's pharma world where reps have little to no influence over Rxs.
     
  19. Anonymous

    Anonymous Guest

    Any ideas on who the contract company will be?