Replies to post #514536 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Doc,

As I see it the company could have done the update to clinical trials for many months before they did it, I really don't know why they hesitated as much as they did. Perhaps more importantly trial results have still not been added to clinical trials and probably won't be until such time as we get the Journal, TLD Statement, and perhaps not until the Annual Meeting is held. I can understand not having clinical trials detract in any way from these other things.

Perhaps the reason they didn't upgrade clinical trials was the hope that they could do a single update that included trial results, but without the Journal they were forced not to do it that way. It seems to me that everything is revolving around the Journal and it will continue to do so unless they actually received regulatory approval before it's out. If that should occur I've got to believe they'll tell the Journal that they're sorry, but they now feel free to tell their story with, or without them.

I know nothing that others here don't know, but based on what we know has been done in the U.K. I can't help but believe that we've made a submission to them some time ago. I believe at any day we could be notified that our submission was accepted, and that's what they'll announce. I believe the U.K. is already impressed with what we've been doing over the years, I'd not be surprised with an approval from them in as few as 30 to 90 days after they've accepted our submission. I believe the odds are better than even that we get U.K. approval this year.

Gary

[flipper44]

I think the FDA should not be allowed to make the guideline process and timelines opaque. It’s a flaw in our system of government. You call regulators, and they’re like, “oh man, you can’t get that, jeez, what are you thinking, they’ll move whenever they want to broski, you can’t expect the government you pay for to work for you, no, no, no, they work for someone else, guess who sucker?”

[dr_lowenstein]

interesting bit of fiction

[Hopeforthefuture3]

Doc L, I seriously doubt there was any legal liability to updating clinicaltrials.gov that they were going to use EACs as the control arm. That seems quite nonsensical. As ATL had found in the fall of 2020 the new SAP evaluation ( including EAC) protocol was known long before from the European sites.
Clinicaltrials.gov should have been updated a year earlier to reflect the actual SAP and perhaps have made the events of 5/10 go better for shareholders