NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

flipper44,

Reply from MHRA (NOV.2021)

Dear XXXXX

Thank you for your email.

You are correct that a facility manufacturing an ATMP must have a current GMP Certificate to manufacture either an IMP(material for clinical trials) or an MA product.

If the facility is in the UK or EU it must also hold either a Manufacture Import Authorisation MIA or a Manufacture Import Authorisation for Investigational Medicinal Products MIA(IMP) depending on what product is being manufactured. If in the UK the facility/company must apply to the MHRA for an MIA or MIA(IMP) and this process could take 90 days, during which time an inspection will also be carried out at the facility. Depending on the time taken to close out the inspection and issue the GMP certificate/s this may be longer than 90 days especially if there are any issues found at the inspection. This application can be made at the same time as the MA application so long as there is an intention to manufacture product at the manufacturing site. However, it should be noted that the processes are independent of one another and an MIA and or GMP Certificate must be in place for the manufacturing facility before the Marketing Authorisation can be granted.

If the facility performing the manufacture is outside of the UK but in the EU it is a the current time the responsibility of the competent authority in that country to carry out such an inspection and issue the manufacturing authorisations, which are recognised by the UK.

If the site is a third country then MHRA would carry out an inspection of that facility and issue a GMP Certificate only. The marketing authorisation applicant must highlight that this is the case so that an inspection can be arranged if required.

Further guidance and application forms can be found on our website:

https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences

I hope that this is of help to you.

Kind regards

Rick

Richard Parker
Senior GMDP Inspector
Inspection, Enforcement and Standards

MHRA, 10 South Colonnade, Canary Wharf, London E14 4PU

pgsd
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Re: None

Monday, February 20, 2023 3:28:17 AM

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biosectinvestor

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Re: hoffmann6383 post# 569156

Sunday, February 19, 2023 9:43:02 PM

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The Innovative Licensing program in thebUK, or ILAP both allows for a rolling approval AND the company and MHRA develop a plan before the application that entails things like manufacturing and broad issues to guide the drug toward approval. They develop a Target Development Profile with the regulators, or a TDP. It has long been my view that NWBO was the ideal drug for this relatively new program and is likely a part of that program.




If you read my thread you will see that early interaction with NICE is a part of this pathway.

See the below graphic from my above Twitter thread. Note the language at the top of this graphic, and the pathway at the very bottom of the graphic. Looks a lot like what we are seeing with NICE and MHRA working together simultaneously rather than sequentially.


pgsd

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Re: None

Monday, February 20, 2023 5:49:40 AM

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u/BIO9999

NICE and its changes as they may relate to $NWBO
Due diligence
Background

NICE is the National Institute for Clinical Excellence and is the UK’s main Health Technology Assessment body. Health Technology Assessment (HTA) bodies study new treatments and determine the degree to which they improve quality of life and years of life and therefore how much value they provide to the health of the person and their caregivers and how much the manufacturer can charge for the treatment. NICE is very highly respected worldwide for its rigorous analysis, and as a result, the rest of the world is moving towards a NICE-like approach.

In the US, drug manufacturers have been free to set prices based on a supply and demand method. However, there are many efforts in the US to move towards a NICE-like model and to also adopt something more similar to international reference pricing (which would also give significant weight to the UK, etc.). An example of the relevance of the UK’s NICE-based system is an article published in late 2022 (https://journalofethics.ama-assn.org/article/what-should-us-policymakers-learn-international-drug-pricing-transparency-strategies/2022-11) in the AMA Journal of Ethics, which stated that the UK, Germany, and Canada had good approaches to drug pricing, and ended the article with this sentence: “For example, the US could permit national payers like Medicare to negotiate lower drug prices or, ideally, employ value-based pricing frameworks to decrease net prices by tying them to drugs’ clinical value.”

Forbes Magazine this week also commented on the subject in an article (https://www.forbes.com/sites/anandparekh/2023/02/16/testing-a-hypothesis-can-we-promote-both-innovation-and-affordability-of-drugs/?sh=460dd1507dbd), saying, “Second, pharmaceutical innovation has led to us being on the cusp of developing cures for conditions such as sickle cell disease and cancer through cell-based and gene-based therapies… Payment would also be contingent upon improved outcomes, a strategy known as value-based pricing…” Again, see how the US Is being encouraged by the most influential medical association along with everyone else to move towards a value-based methodology like NICE. There are countless other examples I could discuss including the FDA’s proposal that accelerated approvals could be tied to value-based pricing until there is sufficient real world data. NICE is being courted by everyone obviously and recently announced that it’s partnering with Australia and Canada in a pilot to assess innovative new treatments, involving quarterly meetings to reach consensus (https://www.europeanpharmaceuticalreview.com/news/175115/nice-partners-with-health-technology-assessment-bodies/).

The changes

Institution of a proportionate approach which speeds up analysis of low-risk treatments.

A Highly Specialised Technologies Programme that speeds up evaluation of rare disease technologies and increases flexibility in the HTA timeline. Related to this is the Cancer Drugs Fund, which aims to ensure that patients with rare cancers and innovative potentially curative cell therapy treatments like CAR-T get treatment costs approved as fast as possible.

NICE’s baseline threshold for any healthcare technologies related to diseases that give a patient less than 2 years to live and the treatment increases life by >3 months, the end-of-life modifier allows NICE to now give £50,000 (from £20,000 previously) per QALY, along with a new severity modifier that relates to how severe the condition is.

Although not final, the discount rate may be only 1.5%.



I’m going to leave the math and the other implications for a future article.

For more information on the topic, you can read this article about NICE’s changes (https://www.pharmaceutical-technology.com/features/nices-makeover-a-new-look-for-uk-htas/).


https://www.reddit.com/r/NWBO/comments/1170ueq/nice_and_its_changes_as_the



https://twitter.com/BIO99_BIO99?ref_src=twsrc%5Etfw%7Ctwcamp%5Etweetembed%7Ctwterm%5E1627546954149552131%7Ctwgr%5Ece5bebbcf91d23694115281228a607797879551f%7Ctwcon%5Es1_&ref_url=https%3A%2F%2Finvestorshub.advfn.com%2Fboards%2Fread_msg.aspx%3Fmessage_id%3D171251516