The batch consistency issue may have been of some value if REM-L has not been used in Japan for about 5 years and JCR is growing the market remarkably. We’ve had an EAP for many years and according to Dr Kurzberg REM-L was highly efficacious.
FDA wants to make an example and show how severe they can get. By their standards (some learned commentators said their ignorance) applicants are guilty unless proven otherwise.
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