biosectinvestor,
I think a correction is in order and it’s not just semantics about the way the halt played out but it could almost seem like it. I believe you are correct about German concerns and that those concerns were shared with NWBO or NWBO knowing of the concerns shared the blended/blinded data or a DSMB look was shared which led to a closer look by regulators. I wish I could find where I read what I am about to say but it’s buried in old notes somewhere I think but have not found. What I do know is how clearly what I am about to say stuck with me.
When I was reading up on regulatory actions I found that if the German regulator imposed a halt they would likely make public the reason for it but if the sponsor voluntarily imposed their own halt they would not. NWBO clearly stated that outside of the US the halt was imposed by NWBO so I think that NWBO was in the process of having German concerns be reviewed by FDA who either were slow to impose the halt after NWBO had submitted their voluntary halt to the Germans or just slow to acknowledge and announce their own halt because they were trying to figure out how to handle it to maintain the blind which the German update to their clinical trial site then forced their hand on. Once NWBO started making press releases and giving numbers that started with a mention of about 300 and ended in 331. That’s when confirmation of the light bulb that went off came. Continuation of enrollment told me it was good news. Keeping remaining SOC/placebo out told me very good news about the product.
What I did not know at the time for sure but suggested was a manufacturing issue was somehow possibly related to outcomes being noted and though the halt may not have had much to do with German “optimization” at the time, the link back to manufacturing issues always kind of stuck with me about the possible need to account for more demand than originally anticipated at some point. Best wishes.
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