Replies to post #369664 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

spartex,

If demand outstrips capacity then operational and logistical considerations come into play hence the approval for Cognate to supply Europe and then CRL plans to expand manufacturing beyond what Cognate was planning to double with an update to future plans expected yet this Spring. Best wishes.

[skitahoe]

I'm frankly not knowledgeable about the use of the Flaskwork device to make our vaccine, but on Investors Village I was advised by a knowledgeable poster that the regulators wouldn't simply analyze the product of producing the vaccine using both methodologies and approve the use of the Flaskwork device. I was told that a new clinical trial would have to be run to prove the vaccine from the Flaskwork was as effective as when done the way it currently is made.

While I believe that there should be an easier way, I'm not certain the FDA will agree to accept that they could try making it both ways and making a scientific determination that they were essentially identical.

I do not know for a fact that the Flaskwork device was not used in the trial, if it were, it may be proven, but I don't believe that's been the case. If a trial must be run, even a small one, it could take years to validate the use of the Flaskwork device.

Gary

[exwannabe]

Why, that quote from 10-K seems to say that the UK facility may not be able to manufacture DCVax products for both the UK other regions, as "this may not turn out to be feasible, for regulatory, operational and/or logistical reasons."

Hence, tap Cognate/CRL to help meet that possible gap.

Yes. Just like any other cellular manufacturer could use CRL to produce product.

NWBO has no relationship with Cognate/CRL anymore. They could go to them as a contract manufacturer. Or NWBO could go to some other contract manufacturer.

NWBO could always have used contract manufacturers that they paid they way anybody does. Setup fee, and cost per batch. But instead they spent 100's of millions building up Cognate.

This board has cheered on these manufacturing developments for 7 years now. As of today, they only facility producing DCVAx-L is the single cleanroom in London able to produce about 5 doses/month.

The resources spent on Cognate and Sawston could have gone into advancing Direct. It would have taken only a couple million at most to run that P1 at Mayo in FL. But that sits idle.

LP is building a cellular manufacturing company. Kool, but that will not be worth anything near what people hope. And she has shelved Direct in order to do this.