NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

For your education:

Meeting name and type
After completion (or near completion) of pivotal Phase 3 trials, sponsors typically request a pre-NDA (drug) or pre-BLA (biologics) meeting with FDA to discuss the planned marketing application. FDA classifies these pre-NDA/pre-BLA meetings as Type B formal meetings, i.e., milestone meetings under the PDUFA framework.

Purpose of the meeting
The goal is to review key elements of the forthcoming NDA/BLA, including clinical efficacy and safety data, to ensure the package and format meet FDA expectations prior to commercial filing. Sponsors use the meeting to obtain direction on unresolved issues, data presentation, labeling, CMC, and post-marketing requirements, thereby reducing the risk of review delays or a refuse-to-file outcome.

These are confidential meetings and FDA doesn't publish results of the meeting. If FDA provides feedback that there is insufficient data to meet FDA requirements and which would trigger an RTF response (refuse-to-file outcome), the sponsor can consider future options to remedy potential filing deficiencies or consider options in other regulatory jurisdictions.