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hoffmann6383

03/11/22 12:06 PM

#450559 RE: Maverick0408 #450556

Don't forget we have decided to go with the TLD AND publication. I agree it is rare for TLD to be this late. You leave out the other part of the equation, which is the publication. The publication, while most likely over the average 300 days that is cited around here, is not significantly past that average when you consider NWBO's timeline includes covid and unlike the BP that took part in this study, NWBO is a small company with limited resources.
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iwasadiver

03/11/22 1:05 PM

#450590 RE: Maverick0408 #450556

How much do you know about clinical trials in general and this DCVax trial in particular. If you haven’t understood what has occurred in full detail then perhaps you don’t know enough to make substantive criticisms about the process. A BLA is not going to occur before announcement of TLD. Period. You have basically a project management team at NWBO and there are multiple things going on all at once, in several different spaces be they regulatory, statistical, manufacturing, and economics. What about the BLA gets announced right after TLD because it’s been ongoing in parallel. It doesn’t sound to me you have a clear grasp on this trial nor on project management. If you do I’d love to hear how you’d do it given the circumstances. I’m a manufacturing engineer and have been involved with multilevel projects so I give them the room they need because I know what’s involved.