NorthWest Biotherapeutics Inc (NWBO)

[ilovetech]

I'm not well versed, as are some others here with regard to the newer regulatory initiatives around expeditious review processes for serious unmet disease treatments. Do these programs require a full ensemble of documentation before any approval consideration takes place? If so, then I would SMH, because really, it would defeat the purpose for creating the programs entirely. Besides the long average wait times for DL, the other absurdly long endeavor is submitting the MAA. If these programs are not meant to intervene before the MAA submission, assuming there would be a lot of consultation, coordination, and collaboration, it would lend one to believe such a preemptive intervention can be made in good faith. If what I've described is not how things are meant to work, then those programs are pie in the sky, because we already have a process called expedited review, which cuts the review time from 10 months to six. Are we to believe that all the hoopla was to cut down the review process another two months or so? It doesn't add up. What am I missing?

ILT