Thursday, January 20, 2022 2:20:43 PM
Doc logic, I believe that you and I are in agreement. From a strategic, operational, efficiency and production capacity standpoint, implementing Flaskworks into the DCVax-L manufacturing process is very important. But, I don't believe it is absolutely necessary to incorporate Flaskworks before initial regulatory approvals.
However, the sooner Flaskworks is incorporated, the better. I believe that NWBio and Advent are working as quickly as possible to get the comparability studies and equivalency tests done. It is possible that all of this will be completed prior to DCVax-L regulatory approvals. But, I do not believe this is a requirement for initial regulatory approvals.
These are my opinions.
However, the sooner Flaskworks is incorporated, the better. I believe that NWBio and Advent are working as quickly as possible to get the comparability studies and equivalency tests done. It is possible that all of this will be completed prior to DCVax-L regulatory approvals. But, I do not believe this is a requirement for initial regulatory approvals.
These are my opinions.
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