Yes, but the value of an ODD is recognised only once a drug is approved in that indication - the value being market exclusivity for a time and a priority review voucher to be used or sold (FDA, not sure about UK).
So if we get approval for IIH, we lock in the benefits of the ODD that was assigned to that indication. But the new ODD then becomes worthless.
So this new ODD, while still awesome news and recognition, is really only of value if we are unsuccessful in IIH but eventually successful in TBI.
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- Ann: Invex Granted European Orphan Drug Designation for TBI
Ann: Invex Granted European Orphan Drug Designation for TBI, page-46
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