Replies to post #449722 on NorthWest Biotherapeutics Inc (NWBO)

[newman2021]

Great idea! How comes no one has thought about it so far? Lets do it. I remember SRPT AdCom where FDA's Woodcock listened to the parents and she approved the drug even though there was not enough data to conclusively prove that the drug works. At the same time she killed Amarin's Anchor trial as data not sufficient but became political savvy to accept insufficient SRPT data. SRPT conducts more trials for expanded indications but never able to prove the drug works well, imo. In contrast, we have a big fat tail of OS curve into 5+ yrs.

[skitahoe]

SF,

DNDN had very activist investors, I believe they attempted to go to Congress, threatened to sue the FDA, etc. I really don't know that they didn't create more animosity than gaining constructive support.

I believe that we should wait for the data and then see what the regulators, and the media does. Right now if you did get the attention of a media outlet, what are you going to tell them. You can tell them Dr. Liau knows, so does the company, but they're not talking.

Even in the case of DNDN, I believe they had the trial results before they became so active. There were a few delays before they finally got an approval, and sadly the company failed, even though the drug was approved. Before it failed, it did hit big highs, and those who traded at the right time made a lot of money, others lost their shirts.

I believe out management has a plan, and I believe they'll be successful. A big part of it is FlaskWorks, I believe they're working hard on that as well as the BLA and assisting with getting the Journal out. In DNDN's case, if they had a device similar to the FlaskWorks unit, perhaps they'd be successful and still trading today. A lower price point might have led to far greater sales, and they could have done it with a device like our FlaskWorks unit.

Gary

[CrashOverride]

Let's take our energy towards contacting Biden and the FDA.

[Smokey21]

I think all of what you suggest is a lot easier in the wake of a journal article which is irrefutable. Right now, we have all connected a lot of dots, but the data is still in the shadows and may be known behind the scenes to some of the RA's involved. Also, I think the demand in the UK will explode when that data is published. Right now, people don't know to what extent and in what circumstances DCVax-L shines. Soon we will all know. Until then, I don't expect much progress in specials and right-to-try taking off.

[biosectinvestor]

The world is a bit more complex than you think.

The compassionate use program was not cheered by everyone. There are people who think drugs should not basically be paid for unless they have been shown to be efficacious and that such programs COULD become a means of corrupting the drug approval process. The laws passed under Obama/Biden, including the 21st Century Cures Act, but there were people in Congress sabotaging it along the way, thinking they were "doing good". The difference is also that the UK program is also flawed and so is the German one. The program that the UK is using, the UK Specials program is not their baseline "Compassionate Use" program but effectively a run around of that rule.

Same problem, in different countries, because there is a group of ethicists and others who really don't like the compassionate use programs and don't think drug companies should profit in any way from selling before approval. The problem is that it is not economical for small, and apparently large companies, to make small batches for some compassionate use patients for really complex drugs at no cost to the patients or at only the cost of the inputs. You still have to have a certified factory, still have to have employees and you'd need to keep them on payroll to make that material, whether you have orders or not. It's not economical.

As for Biden and the Cancer Moonshot, that is a program aimed at things like SHARED DATA, which will benefit situations like DCVax in the long-run, if you can run trials without a placebo and use historical data. It's long-term and focused on large issues. It's not a corruption program for picking winners and losers that kiss the President's butt. I know we saw that in the last administration and it really messed up a lot of really good options we had then for therapeutics, for instance. But that's NOT the way to run a clean program and has little to do with Beau.

President's don't and should not run programs to benefit their families. Is that such an ODD concept? And no, people should not write to anyone encouraging them to embrace the corruption and make us rich.