Italian Biopharm Requests Type A FDA Meeting to Discuss Statistical Plan

Newron Pharmaceuticals has received communications from the United States Food and Drug Administration (FDA) suggesting it discusses its proposed statistical plan in a Type A meeting.

A biopharmaceutical company based in Milan, Italy, Newron Pharmaceuticals, has revealed in a Dec. 9, 2019 press release, that it has received communications from the United States Food and Drug Administration (FDA) suggesting it discusses its proposed statistical plan in a Type A meeting.

The meeting is to take place before Newron discloses which participants received treatment in its Sarizotan Treatment of Apneas in Rett Syndrome (STARS) clinical study. Additionally, it is expected the meeting will occur within 30 days of FDA’s receipt of the meeting request and package.

Newron’s STARS study clinical database has been locked and will remain blinded until after the meeting with FDA. The company had submitted its proposed statistical plan to FDA in September 2019 and was granted the Rare Pediatric Disease designation for sarizotan, the product candidate under evaluation, in November 2019. 

Ravi Anand, chief medical officer of Newron, said in the press release, “We look forward to meeting with the agency to discuss their suggestions for the STARS study statistical plan and are eager to share the final results of the study with the global Rett community and markets, once the plan has been agreed with the FDA.”

Source: Newron Pharmaceuticals