Replies to post #774232 on NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

Thanks for your input Agree with your assessment 

[barnstormer]

Nicely done Slave! Hopefully your input will end some of the arguments raised back and forth today. Probably not, but one can hope - some egos have gotten involved to the point they'd rather argue fine points than substance. My only addition looks at DCVax-L from the standpoint of someone who might have a friend, relative or even myself who might have to deal with a glioblastoma. They wouldn't care what type of studies or testing was involved - their only concern would be does it work and is it safe to use. That was established long ago, so why would it take 18 months for the MHRA to put together the recent proposed guidance that could have been done at least 6 months or more ago?

[Doc logic]

Slave1,

Great job explaining all of this. Just one more important point and that is the level of subjectivity at FDA allows for greater outside influence in my opinion. This entire discussion for example can be one similar to what a review board might go through with some members claiming that without patient level data the interpretation is somehow more likely to be flawed no matter how well the data interpretation is presented and documented. This gives more room for dissent even if not actually factually based on specific circumstances. This is of very great concern for any small biotech which has no monetary influence like big pharmas do to support it through the approval process and has everything on the line. Best wishes.