NorthWest Biotherapeutics Inc (NWBO)

[kabunushi]

The FDA has issued specific guidance related exactly to the issues such as using historic comparisons in immunotherapy trials including trials with no placebo group. In some sense that is the case in this trial because everybody who progressed was given Dc-Vax if they requested it and most did. I don't have a link to the FDA guidance release but that was discussed here and you should def be able to find a link if you care enough to search for it. It was under the previous FDA head who resigned after not long in the position, IIRC. I would be amazed if they would not use exactly the same SAP for all 4 RAs. In any case when they registered the new SAP that was not an event that required specific approval from the FDA. They could have submitted it, waited 60 days for comments and even if comments were received it would still be up to the company to modify the SAP or not.

Imo it's very reasonable to assume that NWBO chose not to disclose the new SAP because they wanted to spring it when the TLD was disclosed just for tactical reasons. The new SAP would certainly be material however it's not a problem with the SEC as long as the information was never leaked to anyone. I'm not a regulatory expert by any means but I believe that WRT to such regulatory affairs and they are complicated by dealing with 4 separate agencies, that the company has considerable discretion about what has to be disclosed when. JMO.