(RTTNews) – Seelos Therapeutics Inc. (SEEL) said it received a positive review in the designated country of European orphan drugs for SLS-00five in Sanfilippo syndrome of the Committee of the European Medicines Agency (EMA) for Orphan Drugs (COMP).
The positive opinion issued through the COMP will be sent to the European Commission, which is expected to grant the designated orphan country within 30 days.
Under the orphaned country designated in the European Union, Seelos deserves to have the wonderfulness of various incentives, such as protocol assistance, regulatory cost relief and market position exclusivity. European rules for the designated country of orphan drugs cover ailments not exceeding five out of one in 10,000 US in the EU.
In April, SLS-00five won a country designated by the Food and Drug Administration (FDA) for Sanfilippo syndrome.