NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

When it arrives, an MIA approval puts NWBO in commercial business for the first time in its corporate history. Free cash flow becomes visible within months. The current Specials permission allows Sawston DC VAX L production for up to 50 patients per month. That's $120 million in annual revenues. As a result of the JAMA paper (11/17/22) and the Liau-Musella combo trial webinar (12/5/22) , the global buzz about DC VAX L breakthrough GBM survival rates has been spreading fast. Sawston now has a backlog. The MIA approval will put on autopilot the MAA approval.The MHRA(the U.K.'s FDA) is one of the world's most respected drug regulatory agencies. Its time, people , and resources investment in the NWBO MIA approval process has been huge. There's no way that investment would have made without the MHRA assuming its MAA approval for DC VAX L .

That said, the NWBO MIA-MAA approvals set off an immediate revenue ramp to $2.5 billion and its derivative $2 billion in free cash flow . DITTO for the USA , with the FDA mimicking the MHRA final commercial approval by 9/1/23.$4 billion in free cash flow 5 years from now gives NWBO target valuation $80 billion ; PV $ 40 billion, or $20 per share .

And don't leave out the potential of the combo royalty revenues generated by strategic alliances with Big Biotech( BMY , Roche, REGN, MRK, , Astra Zeneca, and other checkpoint inhibitor vendors ) . There is also the potential for huge revenues from multi nation regulatory approval for all solid tumors.

DC VAX L's importance to cancer patients is simple to understand. Keytruda, a $25 billion annual revenue checkpoint inhibitor, failed to work in 5 GBM clinical trials.But Keytruda in GBM showed unprecedented survival rates when combined with DC VAX L. (See 12/5/22 Dr.Liau presentation at the Musella webinar. ) All checkpoint inhibitors will work better when dosing includes DC VAX L. Checkpoint inhibitor annual revenues are now $45 billion annually, and are projected to grow to $140 billion in 2030.

A.E.K. 12/20/22 @ 11:38 p.m. Corrected Copy.

https://www.adventbio.uk/

https://virtualtrials.org/video2022.cfm?video=202207 (Dr.Liau 12/5/22 Musella webinar presentation)

https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847 (11/17/22 JAMA scientific presentation on the DC Vax L phase 3 trial )

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=170744320


RESEARCH NOTES BIBLIOGRAPHY:

ae kusterer
Re: None
Monday, December 19, 2022 3:46:14 PM
Post# of 551055 Go
Is the 300 million share naked short position hedged ?
https://cms.mhra.gov.uk/mhra/mia/uk-miaimp-54923… $nwbo @alphavestcap
$1.5 billion of free cash flow in 2027. SAWSTON CAPACITY: 12,000 doses annually x $200,000 x 80 % manufacturing margin. Current market cap $1 billion. MHRA MAA approval by 5/1/23. FDA final commercial approval by 9/1/23 . SAWSTON'S $2.5 billion can be replicated in the USA . Canada? Germany? New FDA agnostic tissue guidance opens up both continents to all solid tumor dosing demand.

3:32 PM · Dec 19, 2022

ae kusterer
Re: None
Monday, December 19, 2022 10:23:56 PM
Post# of 551058 Go
Dan88

Re: flipper44 post# 550914

Monday, December 19, 2022 8:41:08 PM

Post#
550925
of 550954
At this stage without any approved products such as approved DCVax-L, it's of course on the legal basis of INVESTIGATIONAL (clinical trials), ie MIA (IMP). The significance for this is that all parts have been checked ok for finally commercial manufacturing authorization issuance pending product approval.

Once after MHRA reviews BLA, the MIA (IMP) wold change to MIA on the legal basis of HUMAN.

So IMO this is what we should get at this stage, and it's as significant as a commercial manufacturing license pending approval of a manufacturing product.

The authorization for investigational manufacturing had been issued last year on 21 December: https://nwbio.com/northwest-biotherapeutics-announces-mhra-approval-of-license-for-gmp-manufacturing-at-sawston-uk-facility/

No need for MHRA to authorize the same thing twice, although with different forms.




ae kusterer
Re: None
Monday, December 19, 2022 10:23:56 PM
Post# of 551054 Go
Dan88

Re: flipper44 post# 550914

Monday, December 19, 2022 8:41:08 PM

Post#
550925
of 550954
At this stage without any approved products such as approved DCVax-L, it's of course on the legal basis of INVESTIGATIONAL (clinical trials), ie MIA (IMP). The significance for this is that all parts have been checked ok for finally commercial manufacturing authorization issuance pending product approval.

Once after MHRA reviews BLA, the MIA (IMP) wold change to MIA on the legal basis of HUMAN.

So IMO this is what we should get at this stage, and it's as significant as a commercial manufacturing license pending approval of a manufacturing product.

The authorization for investigational manufacturing had been issued last year on 21 December: https://nwbio.com/northwest-biotherapeutics-announces-mhra-approval-of-license-for-gmp-manufacturing-at-sawston-uk-facility/

No need for MHRA to authorize the same thing twice, although with different forms.



Dan88

ae kusterer
Re: None
Monday, December 19, 2022 8:33:41 PM
Post# of 551055 Go
Lykiri

Re: jon_k84 post# 550912

Monday, December 19, 2022 8:19:24 PM

Post#
550915
of 550921
http://web.archive.org/web/20211220205123/https://cms.mhra.gov.uk/mhra/mia/uk-miaimp-54923

Flipper is right IMO.
This is usually because there has been a variation to the manufacturing authorisation submitted and subsequently approved. The authorisation date will therefore have changed.
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Medicines and Healthcare products Regulatory Agency
MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 54923
2: Name of authorisation holder ADVENT BIOSERVICES LTD
3: Address(es) of manufacturing site(s)
ADVENT BIOSERVICES LTD, SAWSTON BUSINESS PARK, SAWSTON, CAMBRIDGE, CB22 3JG, UNITED KINGDOM

4: Legally registered address of authorisation holder ADVENT BIOSERVICES LTD, SAWSTON BUSINESS PARK, SAWSTON, CAMBRIDGE, CB22 3JG, UNITED KINGDOM
5: Scope of authorisation and dosage forms ANNEX 1 and/ or ANNEX 2
6: Legal Basis of authorisation
Part 6 of The Medicines for Human Use (Clinical Trials) Regulations 2004 [SI 2004/1031]
7: Name of responsible officer of the competent authority of the member state granting the manufacturing authorisation Confidential
8: Authorisation Date 19/12/2022
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
ADVENT BIOSERVICES LTD, SAWSTON BUSINESS PARK, SAWSTON, CAMBRIDGE, CB22 3JG, UNITED KINGDOM

Human Investigational Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.3 ] Biological investigational medicinal products
[ 1.3.1 ] Biological medicinal products
[ 1.3.1.3 ] Cell therapy products
Special Requirements
Live Cells
[ 1.3.2 ] Batch certification
[ 1.3.2.3 ] Cell therapy products
Special Requirements
Live Cells
[ 1.5 ] Packaging
[ 1.5.2 ] Secondary packaging
[ 1.6 ] Quality control testing
[ 1.6.1 ] Microbiological: sterility
[ 1.6.2 ] Microbiological: non-sterility
[ 1.6.4 ] Biological
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Click on this link to navigate to www.mhra.gov.ukMHRA
Main navigation
HOME

PIP

PSUR

MHRA-GMDP

ECIG
EudraGMDP Menu
MIA

GMP

WDA

GDP

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Download PDF
Back to search
Medicines and Healthcare products Regulatory Agency
MANUFACTURER'S AUTHORISATION
1: Authorisation Number UK MIA(IMP) 54923
2: Name of authorisation holder ADVENT BIOSERVICES LTD
3: Address(es) of manufacturing site(s)
ADVENT BIOSERVICES LTD, SAWSTON BUSINESS PARK, SAWSTON, CAMBRIDGE, CB22 3JG, UNITED KINGDOM

4: Legally registered address of authorisation holder ADVENT BIOSERVICES LTD, SAWSTON BUSINESS PARK, SAWSTON, CAMBRIDGE, CB22 3JG, UNITED KINGDOM
5: Scope of authorisation and dosage forms ANNEX 1 and/ or ANNEX 2
6: Legal Basis of authorisation
Part 6 of The Medicines for Human Use (Clinical Trials) Regulations 2004 [SI 2004/1031]
7: Name of responsible officer of the competent authority of the member state granting the manufacturing authorisation Confidential
8: Authorisation Date 20/12/2021
9: Annexes attached Annex 1 and/or Annex 2
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
ADVENT BIOSERVICES LTD, SAWSTON BUSINESS PARK, SAWSTON, CAMBRIDGE, CB22 3JG, UNITED KINGDOM

Human Investigational Medicinal Products
Authorised Operations
Authorised Operations
MANUFACTURING OPERATIONS (according to part 1)
Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.3 ] Biological investigational medicinal products
[ 1.3.1 ] Biological medicinal products
[ 1.3.1.3 ] Cell therapy products
Special Requirements
Live Cells
[ 1.3.2 ] Batch certification
[ 1.3.2.3 ] Cell therapy products
Special Requirements
Live Cells
[ 1.5 ] Packaging
[ 1.5.2 ] Secondary packaging
[ 1.6 ] Quality control testing
[ 1.6.4 ] Biological