The results of Regen's study will provide the safety profile data required for filing of an Investigational New Drug (IND) application for the product with the US Food and Drug Administration . Regen intends to file an IND Application in the fourth quarter of 2012 and conduct Phase I/II clinical trials during 2013 and 2014.
Isn't Dec 31st 2012 marks end of fourth quarter of 2012? Any idea when we can expect positive news?
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