Replies to post #682717 on NorthWest Biotherapeutics Inc (NWBO)

[DJPele]

I've been saying this.

We will need a footprint in the US for the FDA to be comfortable, imo. We know this is already in the works from the previous 10k's.

This is what I believe is needed before FDA submission:

1.) MHRA Approval

2.) US Based Contract Manufacturing

3.) Flaskworks Approval (added bonus)

Also, the logistics and planning for our eventual ramp-up of DCVax to the public will take time, money and will come with several lessons learned; it won't be instant and it won't be easy. The UK is the best place to start and learn.

Once we have that set in stone, an eventual rollout in the US will be much easier.

[HappyLibrarian]

This is almost right. MHRA does establish a visible minimum in that we are not going to apply to FDA until we get MHRA approval in the bag.

[manibiotech]

True
And it’s absurd that some are touting FDA approval soon , when there is no clarity about status of FDA application , leave alone submission .

[flipper44]

It seems like the timing, by now, would have led everyone but Sawston planning to start with Eden, or whatever the commercial version will be called.

[drugrunner]

Is that the new BASHER talking point …

Production capacity ??

That means u expect approval based on efficacy.. something u deny existed in the past

FDA will look foolish denying DCVAX under any circumstance once approved in the UK..