NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

vator, there is no need to certify a line now. DCVax-L has not been approved yet, and there are no active clinical trials for DCVax-L in the US or Canada now, except for the UCLA trial that combines Keytruda with ATL-DC (DCVax-L), but UCLA is making the DCVax-L in their own GMP lab on their campus.

From everything I have seen, the basic Agreement between NWBio and Cognate is still in effect until 5 years after the first DCVax-L BLA is approved. But, the NWBio CDMO agreement with Cognate will need to be updated to reflect the updated pricing / cost to pay Cognate for manufacturing DCVax-L, and the amount of dedicated clean room capacity to reserve for DCVax-L production.

I expect that after the TLD is released, and the DCVax-L clinical trial results are published in a top tier peer-reviewed medical journal, NWBio will update its DCVax-L CDMO agreement with Cognate. There is no hurry now, because the current agreement is still in effect, and will not expire until 5 years after the first DCVax-L is approved.

I appreciate your opinion, and the opinion of others like Ex. But, I will stick with the official guidance given to us by NWBio.