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