Replies to post #773135 on NorthWest Biotherapeutics Inc (NWBO)

[attilathehunt]

2:40:52
but I'd like to reassure that we're not prioritising new applications over backlogged applications, so that we have written individually to all companies
2:41:04
with outstanding applications within the backlog recently and some of them,
2:41:12
a small number, have got major objections which do preclude approval at this stage
2:41:17
and they are going through CHM, our Commission on Human Medicines, and as soon as the outcome is clear from the CHM meeting, those will be communicated
2:41:28
to the respective companies. We have put in place new communication routes, so just looking at how do we communicate
2:41:36
and with additional resources in that vein to ensure much more transparent communication

[dennisdave]

well said. I keep repeating it. Im 90% sure the reason for the DCVAXL MAA decision delay can be read in this article. What also can be learned from this article is when the beginning of the end of the delay is starting, if you know what I mean.

https://becarispublishing.com/digital-content/blog-post/uk-s-mhra-issues-draft-guidance-use-rwd-external-control-arms-clinical-trials