Replies to post #493258 on NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

Per the PR and the shareholder letter it sounds like before the end of the year we will have RA approval then commercial manufacturing certification.

[exwannabe]

GoodGuyBill I am a bit confused. It says an application has been submitted, but also says after the therapies receive regulatory approval).
So has it been submitted or will it be submitted after regulatory approval???
TIA

The application that has been submitted is for Advent to manufacture commercial products. It says nothing about DCVax-L.

In the same PR, they say no submission of a BLA/MAA for DCVax-L has been made. They have provided no guidance on the issue, not even saying they plan to submit it.

[FeMike]

Application for manufacturing has been submitted.

The bolded portion was to imply that with the manufacturing certification, they will be able to manufacture DCVax/cell therapies but only if those have received regulatory approval.

Basically it's saying that manufacturing will be ready to roll as soon as an approval is granted.

[GoodGuyBill]

The application has been submitted but the license will not be implemented/received until AFTER approval. This is my assumption... could be wrong.

My focus was that approval is very near!

[DJPele]

I believe they meant:

"Manufacturing will commence only after DC-Vax is approved".

So even if we get our manufacturing license, we'll still need regulatory approval for DC-Vax.