NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

As I understand it, many issues brought to the FDA and other regulators function on presumptive approvals after a specified number of days. I believe this is the case when filing an IND, and likewise a change in the SPA. The presumptive approval isn't iron clad, the regulator can come back after the presumptive period and still request a change, but generally a company is entitled to proceed after the presumptive period.

I got to thinking about how different our lives would be if we operated on presumptive approvals. Let's imagine the presumptive approval time was 30 days. Can you imagine on the first of the month remarking to your wife or husband that you like the new Corvette, or Tesla, etc. and on the first day of the next month you drive home in one. It certainly would make life interesting, all you have to do is mention something you'd like to do, or have, and you're significant other is on the clock, if they fail to say no or discuss it in the 30 days, you're fine in just going out and doing what you mentioned. Of course, if after you've done it they don't like it, you're on the hook to undo it, but they were wrong in not acting earlier.

It's a hell of a way to live, it wastes a lot of time if the key people could sit down and make a decision in minutes, hour, or days. Perhaps more importantly, if a decision is made it's documented, it doesn't mean it can't change, but at least someone's on the hook for saying I accepted it, sorry I was wrong. It also does document the fact that something was submitted for consideration.

The FDA lives in a world where they're allowed 6 months to decide how to make 4 minute eggs, and if 6 months isn't enough, they just say, I'll take longer. If we really ever want to cut the cost of product development and approval dramatically, we need to knock those months down to weeks. A presumptive decision, if they insist on them, should come after a week, not 30 or more days to act.

Gary