Replies to post #509241 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

You make a good case. I remember Dr. Pazdur’s words as well as Dr. Ashkan’s. If I removed all sentiment, and just applied science to explain the potential sequence of countries, I’d say 5-ala usage explains that temporary dichotomy. The U.S. is catching up on that as well.

[skitahoe]

ATL, while I agree with you, I'll also remind you that during the trial GBM was redefined and some patients had what's no longer considered GBM. I believe that those cancers will certainly be covered by the label, but I believe it will go a big step further. Whether the label goes that far, or not, I believe Oncologists with brain cancer patients with operable tumors will go for DCVax-L in all brain cancers.

I certainly believe that when it comes to inoperable brain cancer, DCVax-Direct will be one way it will be treated in the future. While they may not be able to operate, a targeted injection of DCVax-Direct should be possible. Yesterday I believe there was substantial discussion of prostate cancer. I know they say most men who live long enough will get it, frequently it's only monitored if it's determined to be growing so slowly that seniors will likely die of other causes before it becomes a problem. With DCVax-Direct having virtually no negative side effects I believe it will be used in practically every prostate patient that objects to the side effects of nearly all the other treatments. Of course the key is DCVax-Direct proving it's effective in new trials, but based on what's previously been seen, it will happen.

Gary

[biosectinvestor]

I agree about FDA and Pazdur. But the UK’s approval will also flow through the Access Consortium, which will also be a positive and be more than just the UK. It provides access to markets with 145-150 million people.

Of course US approval will be far more meaningful and positive. But UK approval is not nothing.

“The Access Consortium aims to provide patients with timely access to high quality, safe and effective therapeutic products across the five countries. To accomplish this, the agencies work together using high standards of scientific rigour and integrity to reduce regulatory duplication.

According to the consortium, the MHRA will bring additional resources and expertise to the group and will officially begin collaborating as a full member on the 1 January 2021 with a period of shadowing prior to this date.”

https://www.europeanpharmaceuticalreview.com/news/130292/mhra-joins-international-regulatory-consortium/

It’s kind of like Project Orbis and there is some overlap but more countries too. Also former commonwealth countries tend to approve drugs approved in the UK.