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cyclone101

04/10/10 5:21 PM

#5006 RE: Ecomike #5005

very solid news for us -- we knew is boiled down to ' not enough people in the study', and ceo might have not been my choice for the 'speaker'

but now we kknow we are on a holding patarn until 3q



The Company plans to request a meeting with the FDA on both the design of the follow-on study as well as expanded access program for patients who are not participating in the Company's clinical trial.

Later this month, the Company is scheduled to meet with its clinical expert and the co-rapporteurs as it prepares to submit its Marketing Authorization Application ("MAA") to the European Medicines Agency ("EMEA") for review. Based on their feedback and guidance, the Company expects to submit the application in the third quarter of 2010.