Replies to post #239402 on NorthWest Biotherapeutics Inc (NWBO)

[sukus]

Excellent post! Thank you.

[biosectinvestor]

Great post, but this is the result of the 21st Centuries Cure Act which Republicans held up until the end of the Obama Presidency. It was blocked in Congress for years so he’d not get credit, but all of these policies are the actual result of years of collaborative, pragmatic, across the aisle work by those who were not focused on gridlock and partisan politics, but who wanted to advance the process and improve government.

I agree, and I believe that the improved new procedures and standards should smooth DCVax’ path to approval, assuming the final, unblinded data is consistent with the data we’ve seen so far... and why would it be any less, and not actually better?!

This seems more about an exercise of patience than anything else, continued in the face of a constant negative social media campaign by persons and companies yet unnamed, but not necessarily forever anonymous.

[Etienne1]

Great post Hyperopia, thank you !

[Evaluate]

you wrote:

I find it extremely difficult to believe that based upon this large body of evidence of extended survival (the gold standard) and the extremely benign safety profile of DCVax, for one of the most deadly of cancers, with no other viable treatment options, that regulators won’t find a way to approve it.

But if they did? Oh, there would most definitely be a HUGE outcry from the patient advocacy groups. They, along with many neuro-oncologists and their patients have been waiting a VERY long time for this.

Did you mean to indicate that if the regulators did NOT find a way to approve DCVax, that there would be a huge outcry?

[Doc logic]

hyperopia,

Thanks for butting in. Lol. Now I don't need to rewrite a post I lost by waiting to send an unfinished part. By the way, that Phase 1 referrence sure seems to be about Direct based on expected and actual survival charts. Can't wait for SAP buy in, top line and start of Direct trials. Best wishes.

[XenaLives]

But Gottlieb left and the lobbyists remain.

Why would these people not want to maintain the status quo?

I have the same concern for Anavex, a company with a CNS medicine that could replace almost every CNS medicine on the market and reveal the fact that doctors have been giving patients drugs that make patients more sick for decades.

An FDA full of industry lobbyists will try to stifle anything that could destroy the status quo. Anavex has trials in Australia and Spain, with just one small arm for an orphan disease in the U.S. It is wise for NWBO to have trials outside the U.S. Single payer countries like the U.K. are more motivated to do the right thing.

It seems to me that most of them are now headed by former industry lobbyists who seem much more interested in loosening regulations.