NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

I don’t think it works as you suggest. I think they likely stopped submitting questions or comments at some point, which is how the FDA “approves” NDA’s and updated SAP’s.

But, if they decide in the process of approval that they preferred something else, the company is in a difficult spot having said “they approved the update”. It is not in their interest to communicate that info given the litigious nature of things in the US market.

Where the regulator communicates that approval, it’s not the company’s fault if the regulator changes its mind later. The FDA’s job is to keep for itself a maximal range of options in terms of its assessment, and they do not really care what that might mean for the companies. They are focused on efficacy and safety, period.