Replies to post #30043 on NorthWest Biotherapeutics Inc (NWBO)

[antihama]

My belief is that an upgrade to automated manufacturing won’t require another confirmatory trial. I’m guessing that either a Changes Being Effected in 30 days (CBE-30) i.e. A supplement to the NDA/BLA, indicating the intention to make a change to a filing, and that the proposed change will be put into effect in 30 days. Distribution of product can occur 30 days after submission of the supplement, barring notice from FDA OR a Prior Approval Supplement (PAS) i.e. Submission detailing a change that requires written approval from FDA before the change can be implemented, is needed. Whichever supplement they choose would validate and compare the new automated process to the existing process. All the critical tests that you use to ensure the existing process would be used to ensure the new process is equivalent. However, if you change the secret sauce then all bets are off.