NorthWest Biotherapeutics Inc (NWBO)

[HyGro]

NWBO press release on data lock was 10/5/20 made no reference to protocol change. Not until 3/31/21 was an announcement of change in protocol but not details. That's five months later. Repeated it in 3/31/22 SEC filing it. The public details were not made public until May, 2022 TLD.

They may have filed the protocol change with the FDA, but FDA won't approve it until they do a application for approval. That was confirmed by NWBO. As they said: "There can be no assurance that regulatory authorities will allow a product approval to be based upon this approach." In other words, FDA hasn't approved the "new" protocol, SAP, endpoints and comparator.