Replies to post #433070 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

sukus,

Manufacturing and regulatory guidance changes have been the biggest concerns since 2015 I believe with manufacturing being the biggest concern for NWBO to deal with directly. When I posted about manufacturing issues after the halt I remember getting some unexpected positive responses on the message board from folks I had not seen respond before. Project Orbis and rGBM changed the manufacturing need trajectory in a big way perhaps and probably goes a long way towards explaining how much of the timing between TLD/journal article, Sawston Specials, Flaskworks comparability studies and commercialization ramp readiness that flipper44 mentioned in a post about a month ago needed to be lined up. Charles Rivers Labs just announced readiness and that’s a big green light for regulators after the GMP cert at Sawston. Let’s see if they can get someone to set the type on the old manual printing press so the new regs can get published. Best wishes.

[Maverick0408]

Why can’t they just activate contract with CRL? They have the scale and the credibility. I don’t think manufacturing readiness is a strong reason in my mind to keep delaying anymore. If they dangle Flaskworks certification carrot now for not releasing TLD+publication then that strengthens the bear argument and I for one will not be around because I don’t believe in that strategy. However, I don’t think they will do that. They can always work on Flaskworks certification in parallel or post approvals as phase 2 expansion.