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rocky301

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rocky301

Re: None

Thursday, 03/10/2011 7:43:25 PM

Thursday, March 10, 2011 7:43:25 PM

Post# of 92948
Mail ? on todays PR,


"when ACT receives Orphan approval can we start trials in Europe?

No. The EU requires a CTA to be filed(clinical trial authorization). This is similar to filing an IND here in the States like ACT did with both SMD and AMD.

To understand the similarities and differences between the
EMEA and FDA requirements for initial submissions of new
medicinal products
http://www.pharmatek.com/pdf/PTEKU/Sept232008.pdf
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