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HDGabor

09/23/14 8:19 PM

#35206 RE: raistthemage #35205

Amen.

Unfortunately we won't see the order within 6 months (if they continue to appeal it will be still at FDA) and FDA did not breach the SPA, it was terminated entirely by them.
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ziploc_1

09/23/14 9:02 PM

#35209 RE: raistthemage #35205

The Anchor FDA stated that the Anchor sNDA would be accepted for review ONLY AFTER the R-IT study was 50% enrolled. Now the FDA is maintaining that that the Anchor SPA and Anchor sNDA are TOTALLY unrelated issues. Huh? What kind of logic is that?
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raistthemage

09/24/14 2:18 AM

#35214 RE: raistthemage #35205

HD, what is your concieved of sequence of events

Amen.

Unfortunately we won't see the order within 6 months (if they continue to appeal it will be still at FDA) and FDA did not breach the SPA, it was terminated entirely by them.



You seem to be of the opinion the FDA will lose in court but did not breach the agreeement?

If AMRN doesn't appeal to the courts (ie stays within the FDA) how will they ever see a court order.

This is all confusing?