RE:RE:RE:RE:RE:RE:We shouldn't be in this positionI'm wishing they provided a clearer understanding as to why they called us to a meeting to discuss the drug, and then pick apart trial sizes, "how it works", if it's suitable as a primary treatment, and a dozen other things. They already knew these numbers and THEY ALONE "FAST-TRACKED" the treatment. Twice, to my knowledge. Once prior to 2010 and once during the BLA review. You can see in black and white the number of patients enrolled. The data hasn't changed. Why bring the treatment to this point, costing TENS OR HUNDRED OF MILLIONS OF DOLLARS, just to deny its approval now?? They could have done this 3 years ago when ENDO handed it back, and saved everybody a lot of time and trouble. I don't buy the sell off. To quote DimSum, "it's a scam". No one brings a successful treatment like this to the brink of approval after fast-tracking it twice and then say no. No one.
Personally, I think Mickey Mouse could have been at the meeting. The proof is in the data. You want a larger sample size?? Approve it! It's not going to kill anybody. But not approving it will...