NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I think your worst and best are right, but I do believe there is a middle ground that if DCVax-L fails to be approved is more likely. I suspect if it isn't approved it won't be because the data isn't impressive, it will be because the regulators insist on more. Because so many in the trial can be put into subgroups, the regulators may say, no single subgroup is suitable for approval.

The good news in this scenario is that the data would still almost certainly be worthy of a partnership, and the partner would provide all the needed funding to do the trials on both DCVax-L and Direct, even if the partner had no interest in Direct.

I'm not saying this will occur, but if it should, the partnership will take the stock to a new trading range, and it will do so well before any action by the regulators. I expect enthusiasm to be high after top line data is reported, and typically it's a year or more between top line data being reported and filing a BLA and regulator actions. Remember, the FDA gets 6 months to evaluate a BLA, so nothing happens that quickly regardless of how good the data looks. From the FDA standpoint, they feel great if they act in 5 months when they have 6, so nothing simply happens in weeks, it takes several months, and sometimes years when they have questions, even more if additional trials are required.

Gary