Replies to post #195536 on Amarin Corp Plc (AMRN)

[ggwpq]

BB, JW also said, ""The FDA hardly talks about this, but we're really talking about what is the cost of failing to approve an effective therapy versus the cost of making a mistake and approving a therapy that is not effective," she said. "There may be thousands of lives to be lost if you delay for another three years or whatever it takes to get more definitive evidence."

Vascepa's expanded label has been delayed for six years. How many life were lost as a result?

[KevGee59]

Hey BB...

To get me clear - Priority Review gives us a 4 month earlier PDUFA date...ie...September 28th

But Accelerated Approval means that the September 28th...the PDUFA date...could be earlier than Sept 28th.

Two different items...yes??

KG ;)