NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

What gave you the indication of improved manufacturing? While I agree that this is a possibility, I am curious what indications were given. I have read some of the post about the German sites but I don't have as clear of a picture as I would like. Was it from lessons learned with Direct about proper maturation of DC Cells or something else? -- Survivor 1x

1. Patent grant dates. Including this one. https://www.prnewswire.com/news-releases/nw-bios-patent-portfolio-further-expanded-with-manufacturing-automation-patent-223111161.html

2. Fraunhofer started manufacturing for UK (June 2013) just three months prior to the above grant, and Fraunhofer started manufacturing for Germany in June/August 2014.

3. Europe patent for TFF system, which partially encloses the entire process, claimed there was at least one country demanding a more closed system than nonTFF process to prevent potential contamination.

4. You had to be here, but waiting for Germany to get online was a cumbersome process and might be explained by manufacturing modifications. (Note: Much to the surprise of many, manufacturing changes are common during trials.)

5. Direct started manufacturing using the above patent June 2013, the same exact time Germany started manufacturing DCVax_L for trial patients in the UK.

6. Who would not utilize 10X more potency patent(s) that were filed a long time ago and not try to incorporate them into manufacturing optimization?

7. Royal Society white paper suggesting increasing potency should be treated like dosage increase to avoid prolonged adaptation and restarts to trials when new advances made. In other words, quit being so damned inflexible.

8. Dr. Pazdur told AF and other media onstage sometimes companies cannot share reasons for certain actions, and the agencies can't be completely transparent with public due to proprietary manufacturing considerations.

9. This trial is so old that Northwest Biotherapeutics may need to be named North by Northwest Biotherapeutics due to continental drift. The age of the trial suggesting analysis of the second half of enrollment, after German manufacturing initiated, was more critical than in typical trials.

10. Old 2012 interview from LP stating comparing contrasting two sets of data -- one from NorthAmerica and the other from Europe would be really important.

.....those are just a few I thought of in a couple minutes.