Replies to post #215342 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

Lykiri,

The projections that sentiment_stocks gave us indicated that no optimization effect could be much noted by 36 months as her projections based on the methylated vs unmethylated minus the early patients projected out well. If potential optimization affects only best responders then longer term data can improve but earlier data with regard to medians and 1 and 2 year data would not. The 3 year data seemingly pointed to improvement and yet the 3 year survival rate still fell right in line with sentiment_stocks projections. The question then becomes whether or not the 4 year data is improving. Based on comments from various employees of NWBO, not just Les, data is expected to get better and that means late data from the last few patients without actual 3 year data expressed in the KM chart and data from 4 years and beyond might be expected to do this.

The argument that AVII77 makes about late pseudos entering this trial has some validity but these patients do not represent huge numbers. A concentration of proneural methylated will probably be noted but they would be mixed in with other strong reaction DCVax-L responders. My guess is that there was a pretty good reason that the pseudo arm ended enrollment early besides the company not wanting to spend more than they had to to make a solid determination about effect. With this being a potential clue then those late pseudos AVII77 is complaining about, which won't all be proneural by the way, may actually be those who have the best potential to be cured from this treatment. I believe those are the patients we as investors have been stretched to the limit to support and Linda Powers and Les have done everything in their power to prove they are benefitting. Best wishes.

[meirluc]

Lykiri, were most of the last 108 mostly German patients? Were the last 30 or so patients American or Canadian who received their vaccine and placebo from Tennessee?

[doingmybest]

Let me provide an easy example of how optimization could have occurred but not be considered a change. When processes are first developed they have tentative specs until more data is gathered. With the benefit of more process and product quality data are gathered it is possible to conduct correlative analysis as well as process control capability and a target sweet spot for processing of future batches can be set and validated. Say a tentative spec is set at 50-100 measuring units and after a good batch set of say 20-50 batches run it is seen the optimal product performance target is 80 because it has shown the optimize the output of the product measured by product attribute or by patient performance. Say Fraunhofer also applied some automated control to the process to enable NWBO to hold the specified parameter to 70-90 measuring units vs the original 50-100, it would be considered an optimization and not a change. However the product is truly better at an 80 centered range with a tight control around it vs the original 50-100 which may not have been well centered at 75 but may have been allowed to wander between 60-120. Technically this is not a process change unless the optimized spec is found to be outside of the original range but it may be true that the optimized spec leads to much better product/performance.