Original PDUFA date was December 20th 2014. It was most likely a CRL sighting the two unrelated CVOT trials using a different class drug in a different study population as a "scientific" means to delay approval.
The FDA has spent zero time other than defending this position, until Amarin dropped/haulted SPA rescindment procedures. Strikes me as odd (CAPRICIOUS) as the FDA agreed the two issues where unrelated.
Now the FDA has to write IMPROVEIT into the review. It happens to support ANCHOR SPA with Vascepa being LDL neutral, when compared to $Billion dollar Fibrates & $Billion dollar Mixed Omegas.
I'd love to get Eric's hard drive to STS;)
It's all very complex to mix and match the lies and excuses...could take another 6 Months easy.
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