NorthWest Biotherapeutics Inc (NWBO)

[MI Dendream]

I have never launched a me too product, each one has been a new mechanism of action, at least for that disease state. Each one has provided a meaningful benefit to an unmet medical need, although a couple only to a niche group within a population. I work in the US and launch means approval.

Yes, back in my early days of my career, a BLA submission was done with hard copy and it took two semi trucks to transport the package to FDA. It is all electronic now as is the CRF and really the whole Western world. When FDA is motivated by saving lives, they too race to review the package and approve with urgency. Me too products though have to wait until the exact standard PDUFA date and may even be extended at that time.

Two were absolute break-through technologies. One was published in one of the top 3 journals with a corresponding editorial in one of the other top 3 journals calling it the most important medical advance since Dr. Saulk invented vaccines.