Replies to post #257562 on NorthWest Biotherapeutics Inc (NWBO)

[TopelRoad]

I suppose there have been years to prepare for BLA submission and inspection. Perhaps they are at a plug and play status, pending TLD.

[laser777]

I would assume this is all in Dr. Duffy's wheelhouse.

[hyperopia]

Ha ha TopleRoad, that’s a good oneI If anyone thought the SAP was a ginormous task, it’s NOTHING compared to a BLA filing. IF Northwest Bio isn’t bought out or agrees to a partnership, they will have to hire consultants and contract that out, as it is WAY beyond their competence. It takes a dedicated and experienced team 3-6 months or more to file a BLA, but preparations (that Northwest is doing now) usually begin 12-18 months before. I wouldn’t even want to imagine how long it would take Northwest. . . .

Guidance for Industry
Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER)

https://www.fda.gov/media/77755/download


FDA’s Pre-Approval Inspection (PAI) Program and How to prepare for a successful outcome

https://www.fda.gov/media/94064/download