Replies to post #545878 on NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

Problem is, DCVax-L is additive to SOC.

False. There is no SoC for rGBM.

Have a good one Ex! by.

[flipper44]

No, if you read the orbis site, they do not have to file with every member.

For cost neutral, you are wrong on both counts. First cost neutral also takes into account improvement in care (it’s a measurement of how it effects MHRA funding dedication in relation to patient improvement), and on your second point, even if the cost impact was like for like, you are wrong, as there is no SOC for rGBM.

I think you know all this.

[dr_lowenstein]

So dccrap is not Soc thanks

[biosectinvestor]

The point of Project Orbis is for all the agencies to share and contribute in one process. They already have many regulations and procedures that have been set in place to have mutual recognition and acceptance. The point is collaboration, not for only FDA to make all the decisions. This is bilateral with all of these countries. Yes, the FDA runs the overall process, once a company is in the Project Orbis hopper, but there are other ways into that hopper.

We’ll see if they go that route, but it seems the most obvious route with ILAP in the UK and their likely being a top candidate for that program as well.