NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Biosect,

The saddest thing about this halt was the time it took for the regulators to agree how to proceed. If you looked at the German's reason for wanting all to get the vaccine, namely people living longer, it's a shame that all the regulators didn't review the data to date and stop the trial and approve the vaccine immediately.

I know, the regulators simply don't do such things, and perhaps that's the biggest problem with the regulators. They practically never risk their necks, and take really dynamic actions. It's not something I'd want them to do with a drug for a minor condition, but for a cancer that's deadly for 95% of the patients in under 5 years I believe such actions are worthy, but they're almost never taken.

I believe that it's clear that unless all the regulators are acting on concert with one another the U.K. and Europe will be first to act on approval. None of us are speaking about Canada, which may be following the U.S. lead, but I don't believe the Journal, or anything else will be held up waiting for Canada. I also wouldn't be surprised if much of the rest of the world follows the lead in the U.K. and Europe rather than waiting for the U.S. if the delay here is significant.

I know the U.S. FDA is considered the Gold Standard, but I believe that more and more people are critical of all the time and money it causes to be spent in achieving approvals. It is trying to become more dynamic, but even there it takes years to change even the simplest of regulations. When the advantage of products in trials for many years are really clear, it shouldn't take a year or more to apply for approval, or 6 months to grant it.

I suspect that if back at the time of the halt the 4 regulators had reviewed the unblinded data, they could have ended the trial right then, and approved the vaccine. Instead they spent over a year and finally agreed to the German view that all should get the vaccine up front. This also meant the company would have to modify the trial criteria, which also took time, probably more time than they thought while getting all 4 regulators to agree to each word in the change. No consideration is given to all the patients that can't have access to the vaccine because of the time that's being wasted.

Gary