Remember when Amarin (AMRN) said, a little more than one week ago, that the Food and Drug Administration was “unlikely” to convene an advisory committee meeting to review data on an expanded use of its heart drug Vascepa?
Wrong. On Thursday, Amarin reversed course, announcing that, indeed, the FDA has scheduled a Vascepa advisory committee meeting for Nov. 14. The agency’s deadline for making an approval decision on the heart drug will also likely be extended into late December from Sept. 28, the company said.
Amarin shares fell 22% to $13.50.
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Interesting reading!
How come you don’t mention the fda telling the CEO to keep the adcom notification under wraps? What’s up with that? Also didn’t the fda approve the use of mineral oil before the extensive multi year trial that cost amrn millions
How come you don’t mention the fda telling the CEO to keep the adcom notification under wraps? What’s up with that?
July 31st was less than the 60 days prior to the Sept. 28th review date by the FDA. The FDA is suppose to notify AMRIN about wanting to get an AdCom together to assist them on their decision…..THey didn’t extend that courtesy out of Political reasons…..That;s why AMRIN thought the FDA was going to make this detemination on their own…….
I would like to see the SEC do a Forensic Audit on the FDA panel and their family members and acquaintances…Esp. the people that oversee their Blind Trusts….Look at all the options and stocks related to the approvals and Denials by the FDA over the past year…..Follow the Money….I’m sure the SEC would catch a few big fish…..
Otc fish oil contains dha, proven to raise ldl. Results would be significantly better for vascepa if compared to 4g of Otc “whatever is in the bottle” oil.