Replies to post #414970 on NorthWest Biotherapeutics Inc (NWBO)

[trocprofit]

agreed. My take on the delay is that once data was locked, a new process was employed. Where in years past, the data tables and endpoints, curves, comparisons were done in a pretty standard fashion, this changed with our trial. Adding external historical comparisons slowed the process. Then, while evaluating, the SAB, Experts, peer-review, etc...were looking at a trial from a different perspective than ever before. There were likely more questions and requests, therefore, the delay. I think we are close now though. Just will be Journal timeframe now.

[Gus McCrae]

A couple of things: First, the Lancet article and draft guidelines were recently published...the expression of those thoughts, in those documents, appears to be something that NWBO was waiting on, based on some of the summaries of conversations with DI that have been posted here. If the FDA had already accepted the endpoint changes back in October, why would NWBO care about convincing the public that historical controls should be used for its trial? Why is LL advocating for the use of historical controls during her presentations? If the FDA was on board last October, why not release TLD and include a statement that the FDA had accepted the endpoint changes?

Second, the fact that those documents exist does NOT mean that the FDA has accepted that line of thinking for NWBO's request to change endpoints, or at least that they have already accepted it.

Third, with respect to Orbis, if NWBO is counting on Sawston and its 500 vaccines per year, then we are in big trouble (with respect to Orbis only...I'm all for the 500 vaccines and don't mean to downplay the significance of being able to achieve this). 500 vaccines per year doesn't move the needle on anticipated demand. They need a new manufacturing agreement with CRL or they can't satisfy the capacity and rapid manufacturing demands of Orbis, as I understand them. Hopefully a new CRL manufacturing agreement is part of the barrage of PRs LG has alluded to after the release of TLD.

Lastly, if you think datalock means that the new endpoints were accepted, great. I don't know that this is the case. But, if the datalock means with 100% certainty that the new endpoints were accepted, then I don't see why the company needed to wait for the new historical control guidance to come out in the late summer or for a journal article explaining the full trial results.

Look, I don't have any idea what is going on, none of us do. But I do know that what is happening here is unprecedented. There is a reason that no pre-revenue biotech has EVER released trial data in this way. Is it because the results are so good that they need over 13 months to tell us about? I don't know...I certainly hope that is the case.

[foxhound02]

The question is whether they have accepted NW's endpoints, not the overall concept of accepting historical controls.