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Re: None

Thursday, 02/23/2017 12:34:23 PM

Thursday, February 23, 2017 12:34:23 PM

Post# of 16885
EMA

So, if you look at pages 16-20 of this Guidance for Applicants Seeking Scientific or Protocol Advice, the EMA has a mandated turnaround time to provide an Advice Letter of either 40 days or 70 days. If the meeting with Titan occurred in December, they should have already heard or be hearing soon.

http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004089.pdf
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