Replies to post #642037 on NorthWest Biotherapeutics Inc (NWBO)

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flipper44: Right On !

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Re: underpar71 post# 642036

Thursday, October 19, 2023 3:26:12 PM

Post#
642037
of 642043
It’s incredible Advent, our manufacturer of DCVax-l, is continuing to pass post MHRA commercial manufacturing license inspections with flying colors. This bodes well for impending UK launch upon any DCVax-l marketing approval for nGBM and/or rGBM.

$NWBO

Thanks @sharpie510!

A little background on the Human Tissue Authority (HTA) & how Advent performed on their inspection compared to historical numbers

What is the HTA

"The Human Tissue Authority regulates the safe and consented use of human tissue and organs, with… https://t.co/0rqGnUox28

— Hoffmann (@hoffmann6383) October 18, 2023

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$NWBO

Thanks
@sharpie510
!

A little background on the Human Tissue Authority (HTA) & how Advent performed on their inspection compared to historical numbers

What is the HTA

"The Human Tissue Authority regulates the safe and consented use of human tissue and organs, with responsibilities across the UK. We license more than 950 establishments covering a broad range of medical, scientific, research and education settings. We advise Ministers and officials at the Department of Health and Social Care, devolved administrations, and the public and stakeholders in relation to our remit." [1]

Purpose of inspections

"...it provides an invaluable mechanism for assessing compliance with regulatory requirements.
At a local level, inspection provides a snapshot assessment of a licensed establishment. By looking at that establishment’s history, it also informs a longitudinal view. Across the wider cohort of establishments we regulate, inspection findings provide an insight into key areas of risk which, in turn, helps us to develop our guidance and to fulfil our wider regulatory remit." [2]

How many inspections

"...total inspection numbers for existing licences rising from 140 in 2021/22 (when we reintroduced our formal inspection programme as Covid restrictions were ending) to 210 in 2022/23." [2]

What kind of shortfalls are typically found in inspections?

For 2022-2023 there were 210 inspections. [1]

For April '22 to March '23 the following deficiencies were found [3]:

670 Minor Deficiencies
372 Major Deficiencies
9 Critical Deficiencies

1054 total deficiencies

Advent Deficiencies

Two "minor shortfalls". [4]

1. "Examples were identified where the establishment’s documentation did not adequately describe its practices."

2. "A documented risk assessment for the premises has not been undertaken."

What does this mean

To have only 2 minor shortfalls reflects really well on Advent management when it appears the average inspection results in nearly 2 major shortfalls, 3+ minor shortfalls and ~5% of inspections have critical shortfall findings.

Kudos to Advent and $NWBO for running a top notch facility.

[1]https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1178411/human-tissue-authority-annual-report-2022-2023-web-accessible.pdf
[2]https://hta.gov.uk/blog/role-inspections
[3]https://hta.gov.uk/about-the-HTA/transparency/operational-data
[4]https://content.hta.gov.uk/sites/default/files/2023-10/2023-09-08%20%2822694%29%20Advent%20Bioservices%20Ltd%20inspection%20report%20-%20FINAL%20%281%29.pdf
Quote
rj
@sharpie510
·
Oct 18
Final report issued: 18 October 2023 Advent Bio Inspection report on compliance with HTA licensing standards

https://content.hta.gov.uk/sites/default/files/2023-10/2023-09-08%20%2822694%29%20Advent%20Bioservices%20Ltd%20inspection%20report%20-%20FINAL%20%281%29.pdf

#DCVax-L Developed in the USA but Manufactured in the UK.
☝️☝️

$nwbo #ForAllSolidTumors #CancerMoonshot @POTUS @FLOTUS @NCIDirector @NIHDirector
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[ATLnsider]

In my opinion, the initial approval label for DCVax-L in the UK, US, Canada, Germany and the rest of the EU, will include all Grade 4 newly diagnosed and recurrent Glioblastoma, and also all malignant Grade 3 brain tumors, including Anaplastic Astrocytoma and Anaplastic Oligodendroglioma.