NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I wonder if once we provide the BLA to the regulator if they'll want to employ an advisory committee. Frankly, these committees are questionable when they are nearly unanimous in saying a drug should be approved, and it isn't, or vice-versa almost unanimous in saying a drug is ineffective and shouldn't be approved, and it is as recently happened with the Alzheimer drug that was recently approved.

I believe that our results will be so strong as to not require a committee, but if there is anything I've learned from the regulators over the years it's that you never know what they'll do, or what they'll demand. I believe they're much tougher on the tiny Biotech's than on BP's, but you can never be certain of how they'll react in a given situation. I believe we'll have a BP partner before a decision on approval, if we do, I think it greatly improves the odds of approval without delays.

Gary