NorthWest Biotherapeutics Inc (NWBO)

[Love Boat Captain]

You are correct Override but here is some ChatGPT food for thought:

If a company develops a platform technology that is proven to be effective across multiple tumor types (tumor-agnostic therapy) and submits it for FDA approval, the Payment of PDUFA fees can vary depending on the type of application and the specific circumstances. Typically, each application for a new drug or biologic would require its own PDUFA fee. However, if a therapy is approved under a broad indication that encompasses multiple tumor types based on a common biomarker or mechanism of action, it might potentially reduce the need for separate applications and fees for each tumor type.

In practice, the FDA may evaluate the submission based on the clinical evidence and the proposed indication(s) for use. If the therapy demonstrates efficacy across multiple tumor types under a single indication, the company may seek approval for that broader indication, potentially streamlining the regulatory process and associated fees.

Ultimately, the determination of PDUFA fees and regulatory pathways would depend on the specifics of the therapy, its intended use, and how it aligns with current FDA guidelines and policies for tumor-agnostic therapies.