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Benny7459

10/21/14 8:51 PM

#37023 RE: Biobillionair #37022

Since Jenkins wasn't man enough to make decision on his own and had to run to CDER panel that included Woodcock. Why would they have to appeal to her again? Seems like they should just be able to go right to Hamburg herself and get same answer we have gotten over past year. Thoughts?
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HDGabor

10/21/14 8:52 PM

#37024 RE: Biobillionair #37022

It's fifth, fourth was mine :-)

NCE also gives Amarin new avenues of PDUFA appeals according to Regulations.


PDUFA appeals? What do you mean exactly? Especially the "Regulations".

NCE does not effect SPA / PDUFA or anything (FDA) else.
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jessellivermore

10/22/14 8:04 AM

#37047 RE: Biobillionair #37022

Will..

The NCE is a separate issue than the SPA...At this point the NCE issue is less than one hundredth the importance of the SPA.

Enough...":>) JL