Seelos Therapeutics Inc (SEEL): Markkind, After a lot of searching the...

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Dimitrios George

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Dimitrios George

Re: markkind post# 4151

Thursday, 03/15/2012 12:36:29 AM

Thursday, March 15, 2012 12:36:29 AM

Markkind,
After a lot of searching the following appears to be the definitive outline of how the Decentralised (sic) Procedure works: http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/DCP/CMDh-078-2005-Rev3-Clean_2011_09.pdf

We appear to be in the process decribed at the top of page 5 ...but exactly where we are and why it will take until the end of the year is a mystery to me. I thought I knew it but I don't. Damaj said there were questions, presumably from the member states and not the Reference Member State (The Netherlands). Did Damaj say that answers to the questions were submitted back? Are we in the three-month period allowed for answering?

If you or anyone else can figure this out, enlighten me.

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