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EGETIS THERAPEUTICS PRESS RELEASE Egetis Therapeutics AB Stockholm , Sweden , Dec 13 , 2021 Egetis intends to submit a marketing authorisation application for Emcitate® to the European Medicines Agency based on existing clinical data • • • • Egetis concludes , based on recent regulatory interactions , that available Triac Trial I data together with recently published long - term data are sufficient for a Marketing Authorisation Application in Europe Having all clinical data required for regulatory submission already at hand significantly reduces the remaining risk for Emcitate Revised submission timelines will be communicated as soon as all parts of the regulatory dossier are confirmed Egetis will host a webcast today at 15:00 CET ( 9:00 am ET ) Stockholm , Sweden , December 13 , 2021 - Egetis Therapeutics AB ( publ ) ( Nasdaq Stockholm : EGTX ) today announced that after a pre - submission meeting held last week with concerned European regulatory agencies ( EMA's Rapporteur and Co - Rapporteur ) , the Company concludes that the clinical data from the Triac Trial I ( Groeneweg et al . 2019 ) , together with the data from long - term treatment with Emcitate ( tiratricol ) for up to six years in 67 patients ( van Geest et al . 2021 ) will be sufficient for a regulatory review of a Marketing Authorisation Application ( MAA ) to the European Medicines Agency for the treatment of monocarboxylate transporter 8 ( MCT8 ) deficiency . Thus , all clinical data necessary for regulatory submission is already available . The ongoing Triac Trial Il will continue to further establish the effects of early intervention on the neurocognitive development aspects of the disease . " We are delighted with the outcome of the pre - submission meeting , giving us a clear path to our MAA submission , and subsequent regulatory review , based on existing clinical data . Having all clinical data required for regulatory submission already at hand significantly reduces the remaining risk for Emcitate and could also potentially enable an earlier submission in Europe than we had previously expected . This is a substantial opportunity for us and the European patients suffering from MCT8 deficiency . In parallel , as part of our efforts to make Emcitate available as soon as possible , we continue our dialogues with regulatory authorities in other jurisdictions to obtain their views on the available clinical data and its implications for regulatory submissions " said Nicklas Westerholm , CEO , Egetis Therapeutics . In the light of the revised regulatory strategy for submission in Europe , work is ongoing to confirm the content of the other components of the regulatory dossier . As soon as this work is completed , the Company intends to communicate a firmer timeline for regulatory submission of Emcitate in Europe . Results from Triac Trial I ( clinicaltrials.gov identifier NCT02060474 ) were published in the Lancet Diabetes & Endocrinology in 2019 ( Groeneweg et al . 2019 ) , showing clinically relevant and highly significant results on serum T3 concentrations and secondary clinical endpoints following one - year treatment with Emcitate in 46 MCT8 deficiency patients of all ages . The new clinical data published in the Journal of Clinical Endocrinology & Metabolism in October 2021 ( van Geest et al . 2021 ) comes from the investigator - initiated real - life cohort study at 33 sites conducted by the Erasmus Medical Center , Rotterdam , The Netherlands , where the efficacy and safety of Emcitate was investigated in 67 patients with MCT8 deficiency treated with Emcitate ( tiratricol ) for up to six years .