NorthWest Biotherapeutics Inc (NWBO)

[Chiugray]

MID, Your comment the FDA may decide to approve DCVax on its own without using an external Advisory committee got me thinking if there is another reason why the release of TLD is tied to the release of a journal.

Pondering here, let's just say the FDA has seen the results and wants to approve DCVax, but it has to maneuver around these considerations:

- DCVax trial is complex, not simple, and offers a new paradigm in treatment that will need explanation
- Potentially disrupts multiple revenue models across many big pharma companies
- These financial interests will push back and "how" can be unpredictable and from internal and external sources
- A release of TLD alone, a year ago, might have pressured the FDA to form an external Advisory committee to review early on and make opinions, that given above, might be crowded with conflicts of interests (maybe even sabotage).

So the FDA and NWBO, maybe early on and together, recognized the right answer is to approve DCVax outright and in a decisive manner. Take the 2021 year as a quiet period. Use it to simultaneously prepare a BLA and a journal. A journal backed by 60+ practitioners from a respected medical journal could be important "cya". Afterwards on release and publication, an FDA approval can be quick and concrete.