Replies to post #450095 on NorthWest Biotherapeutics Inc (NWBO)

[DavidW2]

The time was better spent on building out Sawston and getting the facility GMP licensed by MHRA. Now NWBio can get DCVax-L approved in all 4 regions now, the US, UK, Canada, Germany and the rest of the EU.

After TLD and the journal article are released, then NWBio can complete the DCVax-L BLA / MAA submission process in all 4 regions. NWBio will then have 4 to 6 months before DCVax-L regulatory approvals to work on updating the Cognate / CRL CDMO agreement.

According to what you said. Since NWBO has received GMP license from MHRA, NWBO should release TLD NOW. What other reason company hold the TLD news? publication? took 17 months to prepare an article? Who believe it?

[Poor Man -]

Is waiting 4 to 6 months to negotiate a CDMO production contract prior to approval best practice?

Learned something new - I thought the mfg facility already has to be in place prior to approval.

Thx

NWBio will then have 4 to 6 months before DCVax-L regulatory approvals to work on updating the Cognate / CRL CDMO agreement.