Replies to post #710467 on NorthWest Biotherapeutics Inc (NWBO)

[JTORENCE]

DocLee It's usually the FDA that leads the way in approval. Other countries feel that if it's good enough for the FDA it's good enough for them. Why she decided to not submit to the FDA first, is a question that should have been asked at the ASM.

[sentiment_stocks]

I don’t believe that any MA has been filed with FDA, but as you mention, it’s possible that a regulatory inspection by the MHRA in the US could help later when the FDA does have the application in hand.

[beartrap12]

DocLee, MHRA is almost certainly conducting inspections in the US for our MAA in the UK because the vast majority of the trial sites for DCVax-L were in the US.
However, I believe the FDA will appreciate any observations and conclusions that the MHRA draws from their inspections when they are ready to evaluate DCVax-L for approval here. As we all know, the MHRA is building close relationships with many countries around the world, including the US, through agreements to share data on new drug trials and MA applications , all so that we can get successful new drugs to market faster.

[martyDg]

Stop your conspiracy theory. FDA is not sticking its nose yet.