Replies to post #775980 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

Not good because they should have submitted an evidence submission by now, not because I believed the fairy tales.

Eh, that's cloudy at best.

Do I tend to lean towards the camp of 'it should have been submitted already'? Yes. But do I see an argument for it not being submitted? Absolutely yes.

Mainly, if they submit the evidence package, it starts the appraisal process. At that point you've got like 3 months-ish before it's being heard by the appraisal committee and guidance is being developed. With a trial this edgy, you almost certainly want the MHRA to have levied a positive response to the MAA prior to the review. It could get hung up in review or have a negative response/heavy draft guidance if it doesn't have approval by the time it gets to this point.