Published: 30. June, 2022
Cessatech A/S announces that the pivotal trial 0205 has obtained regulatory approval and thereby…
Cessatech A/S announces that the pivotal trial 0205 has obtained regulatory approval and thereby green light by the authorities and is now ready to initiate patient recruitment. The trial will investigate the postoperative analgesic efficacy of CT001, in adult participants following impacted mandibular third molar extraction, a randomised, double-blind placebo controlled trial with 220 patients.
Comment from Jes Trygved, CEO of Cessatech
We are very pleased with finally being able to initiate this important trial, and the company is now moving into a different stage with its pivotal study – great work and effort by all the people involved in the preparation of this trial. Unfortunately, it has taken much too long a time and we are disappointed that the approval process, in particular with the Ethical Committee, is so cumbersome and not in favour of an innovative company and industry. CT001 is getting closer to the market and its potential patients and the period ahead will be extremely interesting.
See full press release 220630 – Regulatory green light trial0205