Smooth Drug Development June 2023 News Release

We are working on the following new projects:

• We signed a contract for a bioequivalence trial with Edoxaban.
• We were awarded with medical writing and data management services for Tamsulosin bioequivalence trial.
• Smooth was awarded with a phase III international trial with Esomeprazole.

We are happy to reach the following milestones in our projects:

• We continue enrolling patients in EAEU and India in the international phase III clinical trial of the original drug for patients with chronic myeloid leukemia. 50% of subjects are enrolled (50 subjects in Russia and 42 in India). We are preparing documents for a CTA submission to Kazakhstan and Pakistan to boost the enrollment.
• We prepared CTA submission documents for 5 BE trials for our long-term client.
• All patients were screened in the trial in adhesions during surgeries.
• The first subject was enrolled in the observational program of multivitamins in pregnant and childbearing women in Uzbekistan.
• 114 subjects finished therapy in the phase III trial in post-COVID-19 anxiety.
• The site was closed, and CSR was prepared in the Sofosbuvir trial.
• The CSR was submitted to MoH in the trial in COVID-19 for a German client.