NorthWest Biotherapeutics Inc (NWBO)

[Umibe5690]

Reiterating a post I made about a fairly recent conversation with LG, we discussed the SAP and comments involving the FDA. First, LG made it quite clear that reg approvals/blessings, etc. we're NOT required before submitting the SAP. He also did not specifically say that NWBO received any comments from the FDA or any other regulatory authority.

He did say that the FDA reg guidelines were, in his opinion, a "four corners" response to NWBO's SAP and appeared as a public yet direct response with this SAP in mind. In his opinion, this is "huge" for NWBO. He did say that both Hahn and Pazdur were supportive and eagerly awaiting the results.

In response to why it was taking so long to data lock and TLD, he said that NWBO was being very careful and leaving no stone unturned covering every angle. The opposition forces will be looking for any opening to discredit the results because they are "so good". In response to whether the tail is long AND robust, he emphasized both. They are looking for overall blanket approval from the RAs. The U.K. Is waiting for results and will expedite review with determination within a 3~4 month time frame. When asked whether he was confident of good results, he said...look around, the evidence is there and the guidance is written as though it is responsive to the SAP, However, he did say that, in his opinion, the U.K. will approve first. That will put pressure on other RAs.

FWIW.