NorthWest Biotherapeutics Inc (NWBO)

[Dan88]

Nonsense. Actually it's hard to believe NWBO after 14-years of DCVax-L PIII trial and numerous major rounds of communications with FDA has not been in a rolling BLA submission to FDA.

Yes the document when done could be one or two millions of pages, but it's utterly naive to think that NWBO can only start writing it after TLD and/or from scratch. It's reasonable out of the presumed million of pages, 85% may have been written which may require no additions, changes or inputs.

When I was invited to give a lecture in Columbia U in 2002, I was asked by a student what was the "trick" for me to have written and published 4 peer-reviewed journal papers and 6 conference papers in 3.5-years of my PhD studies (most students took an average of about 5 years in my school and published about 2 papers at that time), I said well I had various modules and templates ready to use and I only needed to make revisions and additions to the modules with new critical analyses and thinking based on new data/findings and then came up with appropriate conclusions.

For a typical BLA, it may contain the following major parts:

"A BLA must contain the following information:
– Form FDA 356h (cover sheet)– Applicant information
– Product/manufacturing information
• Source material / raw materials
• Manufacturing process and controls
• Formulation
• Facility information
• Contamination / cross-contamination information
• Environmental assessment or categorical exclusion
– Safety, efficacy and use
• Pre-clinical studies
• Clinical studies
•Labeling
from https://www.fda.gov/media/77755/download "

So as you can see, most contents can be readily written and probably have already been written. When TLD is ready and detailed analyses of the data are available, the rest of BLA document can be prepared, and revisions and additions can be made to the already written part wherever and whenever necessary and appropriate, which is not to say the preparation of BLA is not a huge task, but to say in definite term that NWBO cannot undertake such a task or NWBO has not undertaken a rolling BLA is equally arbitary.

BTW, Les' mention of submitting a BLA to UK authority by the end of this year may be an exaggeration, but certainly is not impossible.