Replies to post #569425 on NorthWest Biotherapeutics Inc (NWBO)

[Poor Man -]

WW

In your opinion, what are those formalities and how long would those steps take to be resolved?

I assume those formalities will not take very long, almost by definition.

Thx.

[skitahoe]

WW,

This shows how multiple people can hear the same thing and come away with different meanings. I agree that in the annual meeting the company indicated that the FlaskWork unit can make the vaccine, but I believe they also said they continue to work on optimizing how they do it. I have no doubt that they can produce DCVax-L but they're still working to get it so as to have the greatest throughput with the highest quality. Once they've determined what the best way the FlaskWorks unit should be set up, then they'll submit to the regulators and hopefully can gain approval in a matter of months, I hope.

I don't have any idea just what the regulators will require of the FlaskWorks unit. Will making 5 vaccine runs satisfactorily do it, or will it be 10, 20, .... Will they do it with one unit, 5 units, .... I don't believe any of us know what the regulators will demand, nor how they'll judge the vaccine which is made, will they demand one made from the same tumor using manual methods for every batch they run. Will the vaccine come from living patients who'll be able to use the vaccine in treatment, or from frozen products provided by people who're no longer with us. Clearly the company may know the answers to how this is to be done, or perhaps it remains to be established.

My point is, we don't know and I can't be certain the company knows. I don't know that anyone can say that the regulators will do it together, or if each must be independently convinced the FlaskWorks unit will meet their commercial production demands.

Gary