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This critical step in the drug approval process typically requires 6-12 months of intensive effort to assemble all the safety and effectiveness data generated throughout preclinical research and clinical trial phases

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Environ Res 185:109428

In a Complete Response Letter, the regulator stated that Aldeyras New Drug Application did not demonstrate efficacy in treating ocular symptoms associated with dry eyes and informed the company that at least one additional adequate and well-controlled study would be required to demonstrate efficacy