BrainStorm Cell Therapeutics Inc (BCLI)

[midastouch017]

BrainStorm Announces Feedback from FDA Type-C Meeting on Future NurOwn® Manufacturing Plan
FDA provided guidance on introducing semi-automated manufacturing in the future for commercialization

https://finance.yahoo.com/news/brainstorm-announces-feedback-fda-type-140000475.html

NEW YORK, Feb. 9, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today that it recently concluded a Type C meeting with the U.S. Food and Drug Administration (FDA) to review specific aspects of the company's planned manufacturing modifications to support the development of a semi-automated commercial manufacturing process for NurOwn® (MSC-NTF cell). The meeting included a detailed review of the requirements for comparability testing to support future modifications along with geographic considerations in the sourcing of starter materials and future manufacturing production.

"We are pleased with the outcome of the type C meeting and the actionable guidance on FDA's expected requirements for a future semi-automated process," said Chaim Lebovits. "As we consider potential paths toward a regulatory submission for NurOwn, we believe it is prudent to validate and seek guidance from the FDA on our manufacturing plan. The transition from a manual manufacturing process to semi-automated manufacturing is a very important opportunity to increase capacity. It also incorporates measures that are designed to mitigate risk in the manufacturing process. This meeting was a positive milestone toward implementing a new process."

Brainstorm has generated extensive feasibility data on the semi-automated process, the design of which is now at an advanced stage. The company will incorporate feedback from the FDA meeting and its experience from Phase 3 manufacturing to finalize a robust comparability plan that enables semiautomatic manufacturing to be introduced at the appropriate time in the future. It will also finalize the remaining steps necessary to proceed with running NurOwn® conformance batches.

The FDA also provided comments on several key aspects of the current manufacturing process, which BrainStorm will use as the company continues its work to enable operations at its commercial manufacturing partner, Catalent.

"As we review our clinical data with the FDA, we will also continue communications on manufacturing to ensure our plans remain aligned with the Agency's expectations as we advance the development of NurOwn," Lebovits concluded.