ROVI has stopped the Doria regulatory process for 6 months
ROVI has announced that it has required a stop the clock in the process on Day 181 of the EMA process for licensing Doria in order to have time to repeat the bioavailability study (BORIS). The issue is not with efficacy but bioavailability, with the EMA requesting a comparison of Doria with oral risperidone in Europe, despite the company having proved the bioequivalence of the US and European versions in its registration dossier and t ....
02 Mar 2021
Delay in Doria approval
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Delay in Doria approval
Laboratorios Farmaceuticos Rovi, S.A. (ROVI:MCE), 0 | Laboratorios Farmaceuticos Rovi, S.A. (0ILL:LON), 0
- Published:
02 Mar 2021 -
Author:
Ruiz Francisco FR -
Pages:
7
ROVI has stopped the Doria regulatory process for 6 months
ROVI has announced that it has required a stop the clock in the process on Day 181 of the EMA process for licensing Doria in order to have time to repeat the bioavailability study (BORIS). The issue is not with efficacy but bioavailability, with the EMA requesting a comparison of Doria with oral risperidone in Europe, despite the company having proved the bioequivalence of the US and European versions in its registration dossier and t ....