News Focus
News Focus
icon url

stoneroad

08/30/19 6:53 AM

#211877 RE: rafunrafun #211876

Wow. Hope you are correct!!
icon url

ziploc_1

08/30/19 7:59 AM

#211885 RE: rafunrafun #211876

Raf... "I still think that there will be a timely (by September 28) approval."

If you are correct, this would probably mean an approval of the sNDA WITHOUT an even more liberal label for Vascepa, which I believe Amarin has requested,(i.e. to have the FDA issue an approval for Vascepa WITHOUT mentioning Trig levels in the label.)

In that event, the Adcom would have lost its main purpose and might be cancelled...I'm not sure this would be a desirable scenario for Amarin.
icon url

HDGabor

08/30/19 8:15 AM

#211887 RE: rafunrafun #211876

r-

I still think that there will be a timely (by September 28) approval.

Theoretic probability / chance:

.00000001

Reality: 0.00000000%

Best,
G