Replies to post #414980 on NorthWest Biotherapeutics Inc (NWBO)

[VikingInvest]

I can only reply to what I know about. In regard to the CRL agreement, I am assuming based on the mergers and acquisitions I have been fortunate to be a part of, that the NWBO/Cognate agreement that was in place, will be assumed by CRL with terms identical to the original agreement. I highly doubt anything to the contrary, as it would have to have been known at the time these agreements were entered into that Cognate could be acquired at a later date and NWBO did not want to be in a position where it would have to look for new producer of their product. These clauses are in place to protect both parties. So I doubt that they will have to PR a new agreement with CRL. They could include a note that CRL will assume the responsibilities of Cognate and that there is a production agreement that will run x amount of years from date of approval.

[flipper44]

The timing of the draft guidelines would suggest they were initiated much earlier. Remember, before the guidelines were published as drafts at least one company used an external control arm to obtain approval. Data in this the DCVax-l trial was locked 13 months ago, don’t you think that it’s much more likely they got the tentative endpoint change “buy-in” (which is not announced “acceptance”) and then the FDA went about drafting guidelines to formalize its thinking whilst NWBO/UCLA/et al went about developing the journal article format in line with the guidance being drafted, and prior to either coming out, a test case went through the approval process on such basis? Do you really think the FDA fought to fight itself by drafting those guidelines?

No, there was likely buy-in way back by early October, 2020. This does not mean they made anything like a peremptory marketing approval decision, it simply means they bought into the different approach (Aka: adding external/synthetic arm) that must be considered with delayed response trials exhibiting potential crossover confoundment; and, in addition to that psPD confoundment in information arms and other real world data.

Third, regarding manufacturing, manual would probably handle any brief time window between MHRA (potential) approval in the UK, and the NICE price evaluation, then, as if you forgot, there has been a five year development, and another six months of batch runs on the automated closed system patented manufacturing device. It could probably start producing months after approval but concurrent with a NICE decision. (NICE/Orbis/MHRA just conveniently provided such a temporary exception for companies meeting certain requirements) Next, CRL’s Cognate has already been given GMP certification associated with DCVax-l production.

Finally, Dr. Pazdur thinks most manufacturing expansion readiness needs to be in place or imminently ready for expansion if some new SOC is to be ready for increasing global demand. Project Orbis.