NorthWest Biotherapeutics Inc (NWBO)

[Umibe5690]

What has been communicated, to me as well, is that the UK, Germany(EU?) and Canada have accepted the latest endpoints and the trial will be measured in accordance with these endpoints.

The FDA is a different story. They don’t formally approve or “buy-in” to these revised end points. If the FDA does not question or provide comments with respect thereto, the FDA has not objected. But, the FDA retains maximum flexibility and the lack of questions or comments does not necessarily guarantee that the FDA will evaluate the success or failure of the trial based upon some or all of these end points.

Due to the FDA’s retaining maximum flexibility wrt to these revised end points, as explained hereinabove, and IMHO, updating of the clinical trials by NWBO is not so meaningful and could give the mistaken impression that the FDA has indeed “formally bought in.” Hence, in an abundance of caution, NWBO has elected not to update this database. JMHO.