NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Lykiri,

Great post.

Frankly it's sad but this is very much like other Govt. departments, like the IRS operate. You can go to the IRS for an opinion on tax laws and follow their advice, but if Tax Court says your filing is incorrect and you owe, it won't matter that you followed the guidance from the IRS in preparing it, you're wrong and you must pay.

I would suspect that the reason so much time was spent before the trial was locked was to work to get as positive an opinion from the FDA as possible. I really believe that if the other regulators approve, the FDA will also approve, the question is, will they work together and do it together, or will each act independently. I believe the BLA will be filed in the near future, but probably not this year. If I'm right the PDUFA date will be in the third quarter of next year, but the decisions could come sooner.

Gary