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Sunday, June 01, 2014 6:07:43 AM
The division’s response was ‘On January 17, 2014’ and ’Our plan is to continue appealing the rescission decision to successively higher administrative levels’ and ‘And the next set is to appeal up the ladder, and that dispute resolution process involves the opportunity to do that next to the Office of Drug Evaluation II. And then if that's not successful, office -- up to the Office of New Drugs, to see the Director and up ultimately to the Commissioner of FDA. So we're in that process right now. … But it does take some time to prepare appeals from each additional level that we hear back from FDA, for the FDA to respond.’ according to 10-K and CC on February 27. – It looks for me they did not submitted the appeal to ODEII at the time of CC, so it took more than a month to submit.
The ODE II’s response was ‘in late April 2014’ according to 10-Q May 9. – so I guess they submitted it during this week or will during next week.
I sent the question to Amarin – submitted or not, if yes, when – but I do not expect answer since they did not answer the same question for the previous level …
Reps. / partner:
The quality is more important than quantity. I do not remember the name of the company (it was mentioned earlier on this board) but they partnered with AZN at launch. They have a new rep. partner by 2014 (who has 230 reps.) and the Q114 revenue was higher than the full 13 delivered by AZN.
Senate / House:
It takes time. It was mentioned on fdalawblog.net, biocentury.com and blogs only.
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