NorthWest Biotherapeutics Inc (NWBO)

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flipper44, just a summary of current thought:

You are hitting on the many complications of this disease and this trial. Backing up for a minute FDA (RA's in general) expect the sponsor company to understand their product's MOA and all directly related biological effects and explain such in the BLA via science inferencing but mostly science referencing and studies. FDA can and will pose many related questions in this regard. As we all know this is greatly complicated in oncology disease on several levels such as concomitant treatments.

When a trial such as this has a complicated pathway to results the sponsor has one level of challenge to unwind and explain the relevance of the pathway to the results. When a trial has complicated results to explain the sponsor has another level to unwind and explain, relative to the MOA,... The reasons NWBO years ago stated they are hitting on many new frontiers are all these board discussed challenges and they were so right. They are working with new trial regulations and designs, new diagnostic and mfg technologies, and, constantly growing RA expectations for treatment biological explanations.

The good news is that these greater RA expectations grow exponentially when there are safety concerns, which have been greatly minimized by the lengthy trial results. Just like all the milestones and achievements listed by other posters recently I find it beneficial to remind myself when a relevant post occurs of the deep and broad challenges NWBO has tackled to bring this therapy to market.

The great news is that involved practicing oncological physicians want DCVax-L because they know it is the best therapy they have experienced. It is up to the company to clear all the hurdles, both old and new, to bring it to them. One by one it appears they are getting it done. We are I wish we had some visibility into their BLA creation but we will have to judge by the upcoming article and presentations as best we can.

It is fair to say sufficient time has now passed. The window of opportunity, created by a lack of big pharma focus to date will close rapidly given the trial results which will lead to much development work by many.

GLTA