NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I'm not a big fan of Dr. Padzur, I really hope that he was involved in the decision to accept the SAP and is well aware of the results achieved in the trial, but I don't know that's the case.

Years ago Dr. Padzur refused to look at a BLA submitted based on a registrational Phase 2 Trial done by Roche on Kadcyla. His refusal was based on how the trial had been done, but it was pretty clear that his staff had participated in the trial design. His refusal was more about him telling his staff that they were going too far without consulting with him. I hope we're not in a similar position. By not reviewing the submission by Roche the approval of Kadcyla was delayed by years in completing the Phase 3 Trial and submitting on that trial. We'll never know if Dr. Padzur would have approved the drug on the Phase 2 data, but I don't believe Roche would have submitted it if it didn't meet the guidance provided by his staff. Companies don't criticize as they know they must continue to deal with the same people and the people they're dealing with view themselves as G-DS.

I'm not suggesting that we'll have trouble gaining approval, but rather that Dr. Padzur may not know nearly as much as people believe that he knows. Over the years I've often found him to say the right thing when it came to expediting drug development and lowering costs, but his actions have often not match his words as drugs which were eventually approved were often delayed by his decisions to ask for more, often requiring additional trials. I believe our data is so overwhelming that approval will come in a timely way, but I don't know how much to thank Dr. Padzur, or criticize him for delays in either accepting the SAP or causing greater delays at the time of the earlier trial halt.

Gary