Replies to post #798773 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

What people here keep missing is that if an ATMP review expands its CMC package (in this case Flaskworks/Eden) during an ongoing MAA review, then the standard 210-day review timelines no longer applies is out of the window.

OK.

So when we hear in 6 weeks that NWBO has not yet started the testing on Eden needed to be submitted for the MAA change, how does that play out in the timeline to approval?

And why did NWBO slow play this?

[meirluc]

While agreed that there is no MHRA delay, a recent CMC expansion
requested by NWBO would cause an approval delay. Would that delay
not be material information that NWBO would have to PR?

Well, where is that PR?