NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

foxhound02

It’s one thing to be be pessimistic based on normal experience. It’s quite different to be pessimistic under these circumstances when the company probably knew they had a winner in 2015. The FDA has been working closely with NWBO because this is an orphan indication and because NWBO has been willing to be very cautious and deliberate about each step that they have taken. For them not to have been working on a rolling BLA having all this time would be paramount to a crimminal waste of time. Linda would not do that knowing she has a winner and those 17 missing SOC patients revealed this long ago. Five years is more than enough time to rework the SAP and develop the framework for the BLA while waiting for regulator buyin. They had good reason to believe regulators would from the beginning of their changes because of how their trial was set up for patient benefit. This is also the main reason for using historical comps along with others, especially in a disease where treatment has not moved the needle and where SOC is now known not to be beneficial for all and actually lowers the quality of life even for those showing no benefit when given. Do you think Dr. Linda Liau and others had something to do with getting this figured out? Does she have anything really good to say about Optune? Does she “know” because she is “the expert”? Best wishes.