Replies to post #544946 on NorthWest Biotherapeutics Inc (NWBO)

[dr_lowenstein]

LOL as I have explained previously that is a process document, ie if you are going to submist such data, here is how to do it No where does it say that data will be satisfactory, in other words no change in policy

This guidance does not
address FDA’s substantive review of the RWD/RWE submitted as part of the Agency’s standard
review process.