neovir-CoV / Thelma Therap - LARVOL DELTA

Thelma Therapeutics’ Covid-19 drug trial plan rejected (Korea Biomedical Review) - "...the Ministry of Food and Drug Safety rejected its application for a multinational phase-3 study of Neovir in patients with moderate Covid-19....Thelma Therapeutics skipped a phase-2 trial with certainty in the drug’s safety and efficacy and planned a phase-3 trial....The company had reflected the MFDS’ request for revision one or two times but the MFDS recommended a phase-2 study. The company accepted the regulator’s advice and mulled applying for a phase-2 study....Thelma Therapeutics applied for a phase-3 study of Neovir in France and Romania in January and March, respectively. Despite a delay in the phase-3 trial, the company said it would derive study results within this year and roll out Neovir as a Covid-19 treatment next year."

Launch non-US • Non-US regulatory • P3 data • Infectious Disease • Novel Coronavirus Disease