Synektik: The FDA has approved the assumptions of the phase III clinical trial of a cardiotracer

Synektik has successfully completed consultations with the US Food and Drug Administration (FDA) as part of the Pre-IND meeting procedure, the company announced. The consultations were aimed at obtaining confirmation of the proposed strategy for the development of a cardiotracer molecule intended for PET-CT myocardial perfusion studies by accepting the main assumptions of the phase III clinical trial protocol in the United States.

“The pre-clinical and clinical trials, as well as the main assumptions of phase III, were subject to consultations. In the opinion of the company’s management, the positive opinion of the FDA is another important milestone in the cardiotracer project.

The Synektik Group provides IT solutions, modern technology and a full range of services and support for medical facilities in the field of radiology, oncology, cardiology and neurology. Synektik was established in 2001, since 2011 the company’s shares have been listed on NewConnect, and in 2014 they debuted on the regulated market of the Warsaw Stock Exchange.


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