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SidVicious

05/26/15 11:22 AM

#114649 RE: JJAAMMAANN #114647

Typically 90 days for FDA to respond. My guess is that the FDA did respond either with a NO to ODD or that they wanted more info from the company before making the decision. I don't believe AMBS needs to release the result of the FDA just as the company doesn't need to let us know they submitted the application.