Smooth Drug Development July 2023 News Release

We are working on the following new projects:

• We were awarded with 6 bioequivalence trials with Gliclazide, Liraglutide, Vildagliptin, Dolutegravir and Empagliflozin 10 mg and 25 mg.
• We were awarded with a Phase III study in pain with a cream based on bioactive concentrate.
• Smooth is preparing a contract for medical writing and data management services with Nebivolol.

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

• A safety report was prepared for 50 patients in India in the international phase III clinical trial of the original drug for patients with chronic myeloid leukemia. We are waiting for a regulatory decision. DSMB was performed and decision is to continue the trial.
• We prepared CTA submission documents for the Bedaquiline trial.
• All patients were randomized in the trial in adhesions during surgeries.
• 800 subjects are enrolled in the observational program of multivitamins in pregnant and childbearing women.