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Farmas USA

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Farmas USA
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#51260

Re: Farmas USA

un post usano sobre la situacion actual:

"... Currently we are in a vacuum .
Amarin has another 19 days to decide if they are going to continue the appeals process . If they proceed with the appeals then the FDA delays their final decision on the Anchor indication until all appeals are exhausted ...we sit in limbo

If Amarin gives up on the appeals then the FDA moves to their final decision on Anchor ...which will be a CRL .
The CRL will outline ways that Amarin may modify their application or possible open an avenue to discuss allowing some of the Anchor trial data on the prescribing info sheet.

Without the Anchor data on the prescribing info, Amarin will have a tough job selling Vascepa off label and insurance co's may increasingly refuse to cover for off label use.
So the worse case scenario is no Anchor data , insurance resistance to off label use , company tries to survive to interim analysis early 2016 . Based on cash on hand its unlikely they make it to interim analysis data without severe cuts or trying to raise funds . ....so almost dead man walking

What could change ...well FDA could allow some Anchor data on the label to expand sales .
AZN may need to make a deal with AMRN because of their Epanova infringing Amarins patents "

AMRN

#51261

Re: Farmas USA

Déjalo en hígado graso a secas, son los futuros blockbuster, si no, mira ICPT
Compre 11k Amrn a 1,16 paciencia

#51264

Re: Farmas USA

Juega con mis sentimientos la irlandesita...cuando me quiero olvidar de ella,me pega un toque y me da esperanzas....una calientapo*** en toda regla.

Amrn...marcando mi vida ...