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HDGabor

03/29/15 10:14 AM

#46164 RE: rafunrafun #46154

raf-

1.) They could sue for SPA, but the Judge will dismiss the case immediately, since - meanwhile it looks like idiotic - they have to go through the full process. ie. you could not start any case at Supreme Court to get the final decision "immediately".

2.) They could get (if the case will be allocated to the same judge), but could not request. The NCE's Judge is not familiar with the SPA case. The parties are the same, but the topic is different.

3.) SPA / ANCHOR: Binding SPA means that ANCHOR has to be approved by FDA, however ANCHOR could be approved w/o SPA. (I fully agree w the AMRN's decision - did not continue the appeal process - since it was not realistic to expect a positive decision by FDA and the case could take years. Judgement could not be expected before interim result and not a bold prediction to say before 2018.)

AMRN could request of the reimbursement of their legal cost (both for NCE and ANDAs), but could not request additional three years exclusivity.

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biowreck-

Judge Moss and his team do not want to BO AMRN, so I do not think they did a full DD. They could be aware the SPA / ANCHOR issue, but not as a legal issue.