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Just saw a tweet (from Gregory Zivic, MD @metacollectiveG) that $NWBO clarified (MHRA) that the renewal was needed to keep treating patients until a commercial authorization is signed off on. It appears they did both inspections at the same time. Full auth has a bit more paperwork. Likely soon; won’t give one and snub the other
apparently I was wrong though
Hi,
Did a little digging myself and came to this (same) conclusion too: This should be the authorization for commercial manufacturing by the facility. Next up should be the application for regulatory approval for DCVAX-L by NWBO
That's my understanding.
2022-07-06 : Northwest Biotherapeutics Announces Filing of Application for License for Commercial Manufacturing at Sawston, UK Facility
https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-filing-of-application-for-license-for-commercial-manufacturing-at-sawston-uk-facility-301581737.html
The application builds upon the 3 licenses received for the Sawston facility in 2021.
2021-09 : 1- The first license was received in September, 2021, from the Human Tissue Authority of the UK, and provided authorization for collection and storage of human tissues (such as the tumor tissue used to make the lysate for DCVax®-L products) and cells (such as the immune cells used to make DCVax-L).
2021-12 : 2 & 3 : The second and third licenses were received in December, 2021, from MHRA, and provided authorization for manufacturing cellular therapies for use in clinical trials and compassionate use ("Specials") cases, respectively.
2022-07-06 : Northwest Biotherapeutics Announces Filing of Application for License for Commercial Manufacturing at Sawston, UK Facility
The next step for this license application will be another on-site inspection of the Sawston facility by MHRA – this time, inspecting the facility, its procedures, personnel, regulatory documents, capacity and capabilities in accordance with the standards for commercial manufacturing. Following the inspection, a report of the inspection results and any findings needing any corrective action will be issued by MHRA.
Following completion of any post-inspection actions, the Company is hopeful that a manufacturing license for commercial production of cellular products in the Sawston facility may be approved by year-end.
2022-12-19 : Authorization / License received for commercial manufacturing. (https://cms.mhra.gov.uk/mhra/mia/uk-miaimp-54923)
Such a manufacturing license is separate from any regulatory decision about approval of DCVax-L itself.
The Company has not to date (in july this year) submitted an application for commercial approval of DCVax-L.
------------------
So, (to repeat) all this is about the facility.
Mid this year, the facility applied for a commercial manufacturing license and they expected to receive that this year end after previous successful steps. What we saw should be just that, authorization/the license to commercially manufacture.
Next up should be the application for regulatory approval for DCVAX-L by NWBO
That's my understanding.
The numbers are slowly creeping up and they are already cashflow positive for some time now.
Approx 21M revenue, 10M Gross profits and 3M Net profits for 9 months, we could see 28 M Revenue, 13 M Gross Profits and 4M for the full year.. we had worse figures in the past.
As far as I’m concerned, not bad at all.
Income (loss) from operations 1,001,169
Licensing fees 1,196,711
Manufacturing fees $ 4,849,871
Total revenue 6,046,582
Revenue:
Manufacturing fees $ 4,849,871 $ 3,754,721 $ 17,659,834 $ 10,851,425
Licensing fees 1,196,711 1,300,392 3,325,384 2,197,915
Total revenue 6,046,582 5,055,113 20,985,218 13,049,340
Cost of revenue 2,643,175 2,163,376 10,984,021 7,529,918
Gross profit 3,403,407 2,891,737 10,001,197 5,519,422
Operating expenses:
Research and development 1,245,669 986,832 3,337,287 3,032,357
General and administrative 826,019 878,540 2,491,762 2,358,588
Non-cash compensation through issuance of stock options 1,651 11,802 9,261 53,518
Depreciation and amortization 328,899 323,368 990,861 986,001
Total operating expenses 2,402,238 2,200,542 6,829,171 6,430,464
Income (loss) from operations 1,001,169 691,195 3,172,026 (911,042 )
Whois Record for Mill-Lane-SawsTon.co.uk
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New Study to be Presented at #AANAM: Blood Pressure Drug Shows No Benefit in #Parkinsons Disease. bit.ly/2Y53J1x #bloodpressure
Clipper: July 12th
Hi Mocha, what about the disclosure... These guys are not yet into eltp and are not compensated for their opinion... Gold, as far as I can see..
Question is what does "taken orally" relate to? Is there a minimum number of pills needed to be taken before it does not deter abusing or is it already not abuse deterring at the given/indicated dosage?
Thnx for Your DD... That will be an intensive read during the weekend
Excellent DD N2K! We may be in for a pleasant surprise
Thnx Lasers,
I wondered when does FDA use advisory committees?
I found the answer here: http://api.ning.com/files/5GMft5nqv7BOKqS1zb1O3DaTtMIBCOykHmlEgZcWCD*Wb4NtkdmaWTvO6Q97hMkS7Vo3mAmWRLbN7UxQxY2kZn6zxgwFU0m5/PPMDFDAAdCommWebinarSept2015.pdf
In short:
• Meetings can occur during any stage of a product's review process, or if appropriate, once a product is marketed.
• Typically, a committee is convened to assist with interpretation when questions or difficulties related to trial data arise.
• The decision to involve an advisory committee is usually at the discretion of the director of the reviewing division.
After "readonly mode" for at least a two years now on this mb I decided to post here.
I am long ELTP since 2011 and increased my ELTP stocks substantially in the last few weeks. I believe in their concept and patented technology. I do trust the CEO for what he is and does.
I am no trader although I do occasionally trade. ELTP is in my long investment portfolio, as is NVIV & ATHX. I had OCAT too and was invested substantially.
Reason why I decided to post (first time) was the need to give also back as I took only (info)...
I do not like the culture here of rehashing old info / point of views which never seem to change..
Main reason why I'm stil on this board is the presence of some valuable posters with good DD.
Today I learned that KMPH (Kempharm) is having a PDUFA date begin june and basically acts in the same Pain ART with their own patented technology.
I am looking into their technology to evaluate their position vs ELTP. I hope to come back with a head to head comparison.
Clipper
Yes, here exact the same issue..
IS this not comparing apples with pears? Yes they may be in the same phase but there markets are not the same, there potential market share is not the same and thus there pontential revenue (projection) is not the same, hence they differ in (potential) value and marketcap