NorthWest Biotherapeutics Inc (NWBO): Go ahead a read: http://www.fda.gov/d...

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highwayman4life

Re: Adam_Feuerstein post# 65660

Tuesday, 06/28/2016 1:22:04 AM

Tuesday, June 28, 2016 1:22:04 AM

Go ahead a read:

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125650.pdf

Pages 9-10 specifically pertaining to public release of "briefing materials" subject to FOIA.

With regard to certain topics discussed at advisory committee meetings (for example, issues relating to the approval of a pending New Drug Application (NDA), Biologics Licensing Application (BLA), Premarket Approval Application (PMA), 510(k), New Animal Drug Application (NADA), or a supplement to any of these), some of the information listed above might be considered confidential commercial information at earlier stages of the product development process.

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