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Right now we give sNDA approval about a

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MedResCollab   Thursday, 07/11/19 10:49:27 AM
Re: A deleted message
Post # of 339101 
Right now we give sNDA approval about a 40% - 50% chance. However, that is if no AdComm. If an AdComm is announced, that drops to ~25% - 30%, especially if the stated "Agenda" on FDA.gov regards the efficacy/trial design/placebo choice. And then if the AdComm vote comes back majority "no," chance of approval falls to less than 10%.

Still, in any scenario, it could of course happen. Then we see a loss in the consolidated patent litigation for Amarin being >85%.

If they do not get sNDA approval (either in late Sept or late Dec if PDUFA is at some point extended 3-months), and are issued a CRL instead, perhaps requiring DDI studies to exonerate mineral oil in the perceived malabsorption of cardiac medications before granting approval, as our first Citizen Petition requests, then the stock will likely fall below $5, and then continue to below $2. If they get approval, but then lose the patent litigation case, stock will probably also fall below $5, and continue lower to <$2. If they lose both, it will certainly fall below $1, and it won't be long (maybe 12 - 18 months) after that that they are delisted (relegated to OTCBB), and then not too long after that, they will likely cease to be a going concern.

All this from the lofty current market cap of $7.2 billion. Amazing disconnect the market is showing for this ticker.

Regards,
-MRC


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