NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Marty,

I think at times we place perfection above everything else, so any perceived flaw results in delay. I say perceived because many may not think of it as a flaw, but someone does, and until it's resolved it sits. I like the expression that in every project there comes a time in which you must shoot the engineer, and proceed. I believe we're approaching the same position.

I remember a discussion of music in which it was asked if the music stopped, could you name the next note. People agreed that they could, but the notes would be different. That was the point, perfection is different for all of us. Hopefully we're at the point where the company is willing to say the submission is good enough. It will never be perfect to multiple people reviewing it as we all view perfection differently.

If the FDA or other regulator wishes to nit pic anything submitted to them, they can find something to base it on. On the other hand if they're looking at what's best for patients with the diseases being fought, they should avoid the nit picking and approve products. They can always do post approval Phase 4's, or insist on confirmatory trials for full approval if there are any real doubts on their minds.

In our case, with or without the regulators wanting more trials, I believe we'll have them. I believe we'll be going for the tumor agnostic label and we and others will want to co-sponsor trials to demonstrate other products which make DCVax-L far more effective, but where the other products don't work well without DCVax-L.

Gary