Replies to post #425153 on NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

ccie1024: Thanks regarding after 12/6, but no later than????



ccie1024 Friday, 12/10/21 09:35:42 AM
Re: ae kusterer post# 425145 0
Post #
425153
of 425202
WHEN?

With absolute certainty,

after December 6, 2021.




kabunushi Friday, 12/10/21 09:36:25 AM
Re: None 0
Post #
425154
of 425198
Q&A about commercial manufacturing of dc-vax-l in the US

My question to DI and his answer:

Quote:
Hi Dave,

Question: Given that Cognate had produced a good number of dc-vax doses for the ph 3 trial in the US (in Memphis I believe) and for other patients not enrolled in the trial, for us to now start using CRL for commercial production for the US, can CRL be considered by the FDA to be already qualified for commercial mfg or would they have to go through a full qualification process similar to what Sawston is now hopefully within days of completing? Of course, UK vs FDA qualification itself might be different to some degree (I have no knowledge of either country's qualification process). What I'm really getting at is whether CRL has a huge leg up toward or maybe even would already be fully qualified at the ex-Cognate site where they produced many of our vaccines before?


Quote:

It’s a multifaceted answer with tons of possibilities.
I believe that there is an advantage for cognate/crl due to the fact the have already been qualified under the tougher European standards to make vaccine for the US trial and compassionate use. The question/answer can be multi faceted because of Flaskworks.
If we get the facility certified for Flaskworks by MHRA, does that change the calculus for how CRL proceeds. Obviously are many possibilities.
We have worked with CRL before on other projects and like the way they operate. They are a terrific company that potentially could offer all hands on deck approach once is decided which direction they are headed.
As an example/possibility, would they use current technology to ramp production while they duplicate what we have done at Sawston with Flaskworks. This is of course if they are interested in FW and working with us.
As the options unfold,I hope we will be able to add a lot more color.


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