Toleranzia AB (the "Company" or "Toleranzia") announces that the process for the Company's clinical trial application is proceeding in accordance with the medicinal agencies' usual course. On January 8, the Company received a request for supplementary information from the European Medicines Agency (EMA), which is an expected step in the application process, and the requested information has now been prepared and submitted.
The clinical trial application submitted to the EMA in early October has now been evaluated and in early January the company received a request for additional information. This request is a normal and expected step in the application process. Together with our clinical contract research organization, we have prepared and submitted the requested information. A response from the EMA regarding the application in its entirety is now expected before the end of February.
"Although the EMA's request for additional information came somewhat later than we had hoped, I am pleased that we were able to respond quickly and efficiently," comments Charlotte Fribert, CEO, Toleranzia.
For further information, please contact
Charlotte Fribert - CEO, Toleranzia AB
Tel: +46 763 19 98 98
E-mail: charlotte.fribert@toleranzia.com
About Toleranzia AB (publ)
Toleranzia AB (publ) develops drugs that harness the power of the immune system for the treatment of autoimmune orphan diseases. The drugs, which target the cause of the disease, can cure or significantly alleviate the disease and not, like current treatments, merely reduce the symptoms. They have the potential to be the first long-acting or curative therapies that act specifically on the underlying cause of the autoimmune orphan disease for which they are being developed. Toleranzia's shares are listed on the Nasdaq First North Growth Market and Mangold Fondkommission AB, 08-503 015 50, CA@mangold.se, is the company's Certified Adviser.
