Amarin: Prepping for FDA Approval Decision
BEDMINSTER, NJ (TheStreet) -- An Amarin(AMRN) primer ahead of Thursday's expected FDA approval decision for the company's prescription fish-oil pill AMR101:
What time will the FDA decision be announced?
Impossible to say. We may hear in the middle of the day, like we did Friday with Onyx Pharmaceuticals(ONXX) , or not until evening as with Vivus(VVUS) . If you're trading the Amarin approval decision, my best advice is to be ready for news any time after noon EDT. And don't forget that Amarin may decide to halt trading at some point Thursday ahead of the announcement.
Is there a web site I can follow to read about the FDA decision in real time?
Amarin will issue a press release, of course, but I'll be shocked if the company is first out of the gate with the AMR101 news (unless the drug is rejected, which isn't likely.)
Your best bet for instantaneous reporting of the AMR101 decision is Twitter. Log into StockTwits and follow the $AMRN feed. If/when there's real news on AMR101, you'll see it on StockTwits instantaneously. I have a pretty good track record of having a fast draw with FDA drug approval news, so you can follow me on Twitter as well at @adamfeuerstein.
What's the chance that FDA will reject AMR101?
Tiny. I'd give it single-digit odds, certainly no more than that. Investors expect AMR101's approval Thursday by a wide margin -- and rightly so. If FDA rejects AMR101, the outstanding issues are likely to be relatively easy to fix.
Will FDA announce AMR101's New Chemical Entity (NCE) status simultaneously with approval?
Not necessarily. FDA may not make the AMR101 NCE decision public until the Electronic Orange Book (EOB) is next updated, which means Aug. 10.
Amarin has stated previously, however, that FDA may announce its approval decision and NCE status simultaneously. We'll know Thursday.
AMR101? I thought Amarin changed the drug's name to Vascepa?