Replies to post #667615 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Here’s a weekend observation on that.

The UK has is ‘invested’ in:

1. PIMS/EAMS/Compassionate

2. The UK’s most advanced cellular manufacturing plant.

3. MHRA’s return from Brexit, and their impressive momentum with Covid-19 vaccine approval, CRSPR approval, and what’s looking like the first GBM cancer vaccine approval.

4. Dedication to ethical, professional and internationally respected approvals with a highly efficient and thought out simplified process that speeds high impact and well tested therapies through to an approval decision.

5. A recognition that the world, and the UK in particular must do far better in glioblastoma. They are currently in the bottom half of the bottom half in success against this dreaded disease that knocks down people in an excruciating manner.

6. Therapies that change the paradigm from poisons into safe immunotherapies that can be continually optimized.

[eagle8]

Fully agree with you TDD !

GLTU

[manibiotech]

Thanks for your DD , DD :)

“?The EAMS, launched in April 2014, has a three-step process. After the initial PIM designation, the product undergoes further evaluation of its risk/benefit and manufacturing consistency. If successful, it must be approved by the NHS commissioning board. This process aims to provide urgently needed drug therapies to patients more quickly, similar to the compassionate use program in the U.S. ??DCVax-L's designation and subsequent development under the EAMS reflect the MHRA's ongoing commitment to fostering innovation in life sciences, especially for conditions with limited treatment options. This case illustrates the MHRA's role in facilitating the development and early access to innovative medical treatments over the past decade”


Over these years I have become more of a skeptic of accomplishment of any govt agency in a timely manner.

When you see 2014 and facilitating development and early access , I have to wait and see it happen before believing it .
Hope it is early

[antihama]

The Danish Dude

Re: flipper44 post# 667555

Friday, January 26, 2024 7:23:00 PM

Post#
667621
of 667980
Ex couldn't find sources about DCVax-L being ATL-DC in UCLA combo trials even though he was provided and spoonfed with them daily.

He needs an incentive for reason ...

And I remember him saying DCVax-L wasn't in the EAMS program even with the PIM designation indirectly arguing that the PIM designation was so long ago and abandoned, The Specials program proves that wrong and the MHRA working w NWBO since 2014 bodes well for early approval.

Since its designation as a Promising Innovative Medicine (PIM) in 2014, DCVax-L, developed by Northwest Biotherapeutics Inc (NW Bio), has been significantly guided by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. The PIM designation marked DCVax-L as an innovative cell therapy for cancer, specifically targeting all malignant gliomas, including Glioblastoma multiforme, the most severe grade. This designation was the first step in the Early Access to Medicines Scheme (EAMS), aimed at expediting patient access to medicines where there is a significant unmet medical need.