Replies to post #483777 on NorthWest Biotherapeutics Inc (NWBO)

[tryn2]

Public Disclosure of the Filing of New Drug and Therapeutic Biologics Applications With the US Food and Drug Administration
Harinder Singh Chahal, PharmD, MSc, David Szeto, PharmD, MS, [...], and Peter G. Lurie, MD, MPH

Additional article information

This cross-sectional study reviews New Drug Applications for new molecular entities and Biologics License Applications for new and biosimilar biological products submitted to the US Food and Drug Administration to assess how frequently applicants disclose applications in the media.

Current regulations prohibit the US Food and Drug Administration (FDA) from publicly disclosing the existence of pending New Drug Applications (NDAs) or Biologics License Applications (BLAs) unless previously publicly disclosed or acknowledged.1 Applicants may disclose applications in press releases, Securities and Exchange Commission (SEC) filings, or in other media; how frequently they do so is not known.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6547098/

[biosectinvestor]

I do not believe an application is a required to be disclosed material event, but a flat denial would be. Most companies PR, but there could be reasons such processes are quiet. I believe the Project Orbis process may be confidential, as also the UK’s new accelerated program may have elements that are confidential and that plug into FDA programs as well.