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doi:10.1016/j.pneurobio.2014.11.004

You must understand that the issuance of the 483 is an initial FDAs regulatory action as a result of their inspection and the issuance of a WARNING LETTER is the next level of FDA regulatory action

Regardless of these results (expected in 2016), Phase III trials will be designed to determine whether intranasal glutathione has a disease-modifying effect in PD