Thursday, December 01, 2016 10:15:25 AM
The FDA did not catch anyone doing anything wrong. You continue to say that the FDA 'challenged' Roth to go to Compliance, but this is just not true. The FDA 'invited' Roth to apply for approval as a drug. Applying for drug approval is optional (ie not a requirement).
These are the facts and they are undeniable. The proof?...just read the FDA letter.
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