NorthWest Biotherapeutics Inc (NWBO)

[Smitty5150]

In short: Seeing the excellent safety profile and stellar results of the PH3 Study, once DCVax-L is approved by the FDA, these other trials may will be accepted for approval even though they are smaller in size and short in duration. To make an educated guess, if we are seeing 50+% OS in these combo trials, the FDA will approve in short order once data is generated and shown to the FDA.

The FDA is migrating from the old-school large N, long duration trials that cost millions, too smaller, shorter trials, particularly in deadly disease realm. GBM and Alzheimer's are at the top of the list. Most retail investors fail to realize these changes and are not taking into account on what the 2023 FDA will/will not approve, and just how quick approval can happen. The landscape surrounding drug approval is changing, big time. I have friends at the FDA Oncology Center of Excellence, so I know this to be fact.