Replies to post #3391 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Sorry Ou, I had to run off before doing a final edit on that last post. There were a few typos.

I'll be here and there over the next few days, so I'll likely not post during that time.


I just wanted to add this last opinion before my brief hiatus.


That is, I think NWBO's prior timeline was messed up by the German approval process. It required far more man-hours than previously thought; moreover, I think it required an enrollment slowdown. (Its just my hunch, but I think the Germans might have some predetermined minimum amount of patients contributing to the 312 phase III trial.) I think the German delay made all the timing go off course. For instance, NWBO was ready to share enrollment status updates from March 2012 forward, but when the Germans made their enrollment start date impossible to establish, NWBO had to just grin and bare it. Likewise, the enrollment end date had to be pushed back. Likewise the Final results had to be pushed out to early 2015. Likewise, NWBO probably does not want to upset the apple-cart with Direct until those German clinics actually open. European involvement is quite critical to NWBO's 2 continent plan, and the German regulators have, in my opinion, not been moving fast enough. People are dying. I arrived at this overall opinion after reviewing all NWBIO material for the last 18 months, poster comments, outside analysis and my gut.

[ou71764]

Flipper, even though 15 patients per quarter sounds low given what we know about the vaccine now, I suspect that initial enrollment was less than that for the first few quarters.

I don't have enough data to guess what the stats were in December. I think it's likely that the data was very good but hadn't reached statistical significance yet.

If the data is coming in as good as I hope, and the only reason we get the "continue" instead of the "halt" is because there weren't enough patients yet, then a halt at the 2nd interim analysis becomes far more likely.

I wish we could see the data and not just get the DMC's recommendation.