Replies to post #448668 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Newman,

I'm curious whether the FlaskWorks unit would be certified by all 4 regulators simultaneously, or if they're going after one at a time. In that it's the U.K. where DCVax-L is available under compassionate use, it would figure that the trials of the FlaskWork unit is being conducted there. Hopefully all regulators will respect the work being done, but I don't know that it is certain.

It's my belief that even if only one regulator certified at first it wouldn't take long before the others would concur, it would happen at the same time they approved the vaccine.

Perhaps something else worthy of discussion is inclusion in the SOC. A poster made the point that insurance might not cover DCVax-L until it was considered part of the SOC. I cannot see how a product that improves SOC treatment by a factor of 2, 3, 4, 5 or more wouldn't immediately become part of the SOC, but if people more experienced than me believe this is possible, and that we'd have to fight to make it part of the SOC, I'd like to hear their reasoning.

Gary

[biosectinvestor]

Could be exciting developments down ahead. Fingers crossed! :) obviously we don’t know. But IMHO, seems a decent prospect in my book.

[dmb2]

We know NWBO will need capacity in the thousands after approval and not hundreds as they currently possess. If they have that plan well in progress I don't see approval being held up. But it is very positive if the Flaskworks development is close to implementation. I presume DI means approved when he says certified and I am sure the change to Flaskworks requires a submission, so it would mean the submission was already made. Typically changes like this can be approved in 6 mos so that would align with a summer comparability study. If this is true it is quite impressive, hopefull so.

GLTA