JL, Raf & BB
Reading the FDA Law Blog, it clearly mention the below:
"Under that regulation—the validity of which Eisai does not challenge—the exclusivity period for a new drug begins when the FDA issues its letter approving the drug, even if the drug’s manufacturer must await DEA’s scheduling determination before it can bring the drug to market. The regulation does provide for an exception under limited circumstances. But the FDA has interpreted that exception narrowly, and the Court is bound to defer to the agency’s reasonable interpretation of its own regulation."
The regulation does provide for an exception under limited circumstances----could it be the case for AMRN, an exception which will make up the lost period of no decision and later NME decision...just a thought, what do you think guys?
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