Seelos Therapeutics Inc (SEEL): European Approval of Vitaros is imminent...

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daviscupper

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Monday, 02/13/2012 7:33:43 AM

Monday, February 13, 2012 7:33:43 AM

European Approval of Vitaros is imminent. It could happen at any moment.

We filed an MAA (marketing Authorization Application) in Europe on April 27, 2011. It was accepted on june 28th. We filed in accordance with the decentralization procedure (DCP) and are using the Netherlands as our reference member state (RMS). Under this procedure we can receive identical commercial marketing approvals from several member states.

Now, why is approval very likely to be announced at any moment? Well, the entire process takes around 240 days. Yes, it can be a bit longer or shorter. Now, let's do the math. The MAA was accepted on June 28th. Now 240 days is approximately 8 months. That puts acceptance in late February, plus or minus a few days. Hence, Vitaros approval in Europe could be announced at any moment.

A European approval of Vitaros could be Dr. Bassam Damaj's surprise Ace-the-hole and the reason institutions gobbled up the 4.94 million units in a nano-second. Cheers.