News Focus
News Focus
Followers 232
Posts 26887
Boards Moderated 0
Alias Born 01/12/2013

Re: Babr post# 238626

Sunday, 01/05/2020 11:04:53 AM

Sunday, January 05, 2020 11:04:53 AM

Post# of 448085
Babr-

weak marketing to say the least so far.



Agree. But Amarin first needs to get approval through The Office of Prescription Drug Promotion (OPDP).

Here’s more about OPDP:

https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp

We know the above process is ongoing because Amarin has stated its ongoing and FDA hasn’t been brave enough to release REDUCE-IT clinical trial snapshot here:

https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots

Is Amarin 100% satisfied with label...my opinion is no; FDA should have had a lower TG and prevention of cardiovascular death in indications. Again, this is just my opinion and I don’t care to waste time on nuances of label wording...my only point FDA & Amarin will spend too much time on OPDP process because CDER f’d up labeling....hence marketing delayed until end of Q2.

BB


If you're not good at being yourself, then maybe that's being yourself!

Volume:
Day Range:
Bid:
Ask:
Last Trade Time:
Total Trades:
  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y
Recent AMRN News