Our client was committed to applying a deep understanding of axon regeneration and neuronal signaling pathways to transform the lives of patients afflicted with neurotrauma or neurovascular disorders; its lead product was in development for acute cervical spinal cord injury. The client required FDA advice on its intended Phase II trial design and other non-clinical aspects on the program and therefore required support in preparing for a Type B meeting with the FDA's Division of Neurology Products.
Solution:There were several key areas on which the client required FDA response to, these included:
- Clinical: To reach agreement with the Agency regarding the design of a Phase IIb trial
- Chemistry, Manufacturing, and Controls: To discuss plans to re-derive the product Master Cell Bank following discovery of the use of animal-derived products as well as minor proposed modifications to the downstream processing
- Nonclinical: To discuss the whether the nonclinical toxicology package is sufficient to support approval.
- Introductory and Administrative Information Section
- Brief Background Information Section
- Specific Questions for Discussion Section
- Overview of Development Program To Date
- Proposed Phase IIb Trial Protocol
- Proposed Investigator’s Brochure
- Proposed Data Monitoring Committee (DMC) Charter