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You were absolutely right .... love to see the new investors comming on board and moving the price
Have just asked PR if they can provide me the ppt or webcast. Will let you know if I got any respond.
Here is a link to recent IRENA study on biofuels for aviation: https://www.irena.org/-/media/Files/IRENA/Agency/Publication/2017/IRENA_Biofuels_for_Aviation_2017.pdf
See page 30 for some of the producers of biofuels for aviation.
Exactly when the Boeing news about moving to sustainable fuels hit the market GEVO starts climbing feom 9.3 to 11 in AM .... very nice correlation
Boeing Commits to Deliver Commercial Airplanes Ready to Fly on 100% Sustainable Fuels
https://boeing.mediaroom.com/2021-01-22-Boeing-Commits-to-Deliver-Commercial-Airplanes-Ready-to-Fly-on-100-Sustainable-Fuels
Slide 19 talks about Equity Partner(s), not only Debt ... more dilution is comming as part of financing needed
New SmithOnStocks NWBO report is out: https://smithonstocks.com/northwest-biotherapeutics-reason-for-yesterdays-stock-surge-nwbo-buy-1-12/
NWBO on Stuttgart Boerse in Germany has woken up ... price over 1 EUR (1.18$)
https://www.boerse-stuttgart.de/en/products/equities/stuttgart/a1j5ey-northwest-biotherdl-001
My first sales bid for 9k stocks waits for buyer on 3.25$ ...
“Gilead Sciences Inc. will pay $21 billion to buy biotech Immunomedics Inc. and its prized breast-cancer drug, the company said Sunday, a sign of the value of the cancer-drugs business.”
https://www.gilead.com/news-and-press/press-room/press-releases/2020/9/gilead-sciences-to-acquire-immunomedics
He is an old guy. No further comments needed...
0.64 EUR (cca. $0.75) current bid and firat trades on Stuttgart Stck Exchange in Germany.
https://www.boerse-stuttgart.de/en/products/equities/stuttgart/a1j5ey-northwest-biotherdl-001
Stuttgard stock exhange Germany: last trade today at 13:43:20 (Germany time zone) at 0,33 EUR (0,36 USD)
19.99 end of March
My sale order sits at 19.99 ??
Guys, NWBO, as a lot of similar biotech stocks is a pure "LasVegas style" bet. If you are All In, you loss it all or you win big. Personally, I double my bet every week.
with Heights Capital on board
If NWBO PPS follows the PLUG PPS movement after Heights Capital Management enter with 10%, than NWBO can be arround $20 near ASCO
http://www.bizjournals.com/albany/blog/2014/01/plug-power-reveals-new-largest.html?page=all
Reimbursement in EU: further reading
First, my opinion regarding the question from langusa about hospital or national based reimbursement approval in EU (Germany):
Reimbursement is at a level of the EU Member State (i.e. Germany in our case) not EU. Since each hospital has to apply by itself for hospital exemption, my interpretation of NWBO PR and my conclusion is that reimbursement is also on hospital level, not EU Member State level.
Since in hospital exemption program, hospital and hospital professionals have to take their shoulders also a lot of responsibility regarding safety of the treatment, (which is I believe another proof of the hard work Germans have invested into DCVax) is kind of competitive advantage for a hospital which take a risk to have the advantage on the treatment cost reimbursement side.
I am not an expert for the topic, but definitely there is a blue ocean we are in. And since there is almost NO experiences on the market I sincerely believe, that German authorities would not give hospital exemption to NWB without looking under every stone and turn around every piece of data available to them.
Further on, I choose for you guys some links to materials where you can by yourself find pieces of information regarding hospital exemption and reimbursement. I believe more expert forum members will find even more conclusions than me.
But definitely we have fast-track market authorization for DCVax in play here and definitely NWB is the one of absolutely first biotherapheutical players which will make money out of that.
1. Statement from PEI employee regarding The European hospital exemption for gene therapy:
http://www.researchgate.net/publication/221750195_The_European_hospital_exemption_clause-new_option_for_gene_therapy
2. Useful presentation by Analyst from SELECTBIO US (based on EMA workshop in Germany from end of October 2013) with insights in:
- ATMP (Advanced Therapy Medicinal Products) in EU
- Pathways Leading to Market Authorization in EU
- Hospital Exception in EU
pay attention to slide 10 and 12
http://www.genengnews.com/media/pdf/GEN-Biomarket-Trends-Report-ATMP-Regulations-Across-the-EU.pdf
3. Roles of EMA and National Authorities by UK MRHA inspector from October 2011
pay attantion on Hospital Exception description on slide 9:
http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2012/02/WC500122177.pdf
4. Detailed legislation informations regarding ATMP:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000294.jsp
Looking forward for replays from forum experts ?
Re afford567: "Zee Germans" happend if you ask me
for fun:
Could not agree more with you, RRR !
I would just and whole EU as a market within 1y time frame, which multiplies market for DCVax by at least conservative miltiplier in the range of 2-3.
answer to longusa: Reimbursement harmonization on the EU level
Let me once again emphasize that we are talking about completely new legislation on EU level without any experiences or existing case studies. The reimbursement in Germany does not mean direct reimbursement in all EU countries. My statement is that there is a legislation in EU in place, which enables faster entry of new treatments approved in one country (Germany in our case) to other EU countries without repeating the trials, studies, etc in each and every country. But there are still country specific processes to be fulfilled and those processes are not yet "business as usually".
This is my best guess how things can work on EU country level:
First, there have to be understanding and knowledge among oncologist community on each country level that there is a possibility for new and more effective brain cancer treatment in Germany with DCVax-L.
Second, the treatment have to be approved on a country level in a similar way as German Hospital Exemption.
Third, someone have to propose national healthcare insurance body on each country level to reimbursed that special treatment as a Hospital Exemption in Germany. The question here is if treatment can be done locally or only in one of those 6 German hospitals which are in the DCVax-L Hospital Exception program.
Third, financial and other conditions for reimbursement of the DCVax-L treatment in Germany (or from Germany) on country level have to be negotiated and finally put into standard procedure (and this still have to be completed in Germany - PR stated that it will be done in following months).
My guess is that each step could take up to 6 months, all together up to 18 months. The harmonization is a good thing for DCVax-L and will bring results faster than before, but it will take time before full impact on NW income and profit.
When I will have some more information I will share with you.
Yes, this is my best guess Dok.
reimbursement in Germany - correction of my previous post
Dok, have to correct myself, I put it wrong - reimbursement for DCLVax-L is approved (as stated in the PR) in Germany. But the truth is that negotiations will take some months before conditions will be defined.
Thank you.
German reimbursement recommendation is currently valid for Germany healthcare system.
I have stated in my previous post, that the EU directive regarding local healthcare legislations is currently in place (not yet fully implemented, but legislation shall be done in all member countries till last October) that specific level of health care to which an Italian citizen is entitled in Italy can be provided by chosen medical institution which is a part of national healthcare system in any EU country. That could means, that Italian can accept the treatment by NWBO in Germany, but his Italian healthcare insurer have to approve that treatment will be reimbursed. My understanding of the German PR was also that reimbursement was recommand by German PEI not that reimbursement is already a fact.
When we are speaking about EU health care system, please have in mind that there are EU Directions on the EU level and local legislation which have to follow the EU Directions on the country level.
EU is basically following the goal that for each EU citizen healthcare services can be provided throughout Europe regardless the citizenship.
Quote from EU healthcare strategy documents:
"The freedom to receive health services throughout the European Union must be accompanied by guarantees of quality and security. In order to make an informed choice, patients must be able to access all the information they require on the conditions under which they will receive healthcare in another EU Member State and the conditions under which they will be reimbursed once they return home.”
Some additional quotes from EU Directive regarding healthcare to help you understand the situation in Europe:
Member States will cooperate on the implementation of the Directive. In particular, they will support the creation of European reference networks of healthcare providers, which aim to facilitate the mobility of expertise and access to highly specialised care through the concentration and joining up of available resources and expertise.
Member States shall recognise the validity of medical prescriptions issued in other Member States if those medicines are authorised in their country. Measures must be taken to help health professionals mutually recognise and verify the authenticity of prescriptions.
Member States are also encouraged to cooperate in the treatment of rare diseases through the development of diagnostic and treatments methods. The Orphanet database and European networks can be used in this respect.
E-health systems or services also enable the provision of cross-border care.
This Directive provides for the establishment of a network of national authorities responsible for ‘e-health’ with the aim of improving the continuity of care and guaranteeing access to high quality healthcare.
Lastly, the creation of a network of authorities or bodies responsible for evaluating health technologies will facilitate cooperation between the national competent authorities in this field.
Summary of EU Directives regarding cross boarder health care. http://europa.eu/legislation_summaries/public_health/european_health_strategy/sp0002_en.htm#key
Summary about rare diseases: http://europa.eu/legislation_summaries/public_health/threats_to_health/sp0012_en.htm
Deadline for transposition EU directives in a local legislations throughout Europe have been october 2013. Implementation could means more than a year. But my guess is that rare diseases could be approached via fast track.
Nevertheless, I still think that German hospital approval means an open door to the EU market for NWBO in one or another way. And that that also means time – the market reach can not be e over night.
And pls dont forget EU have more habitants than USA, more social oriented healthcare local systems than USA in place (health care is basically available almost to all citizens) and the highest GDP on the world. For details check my first post on the same subject.
Good luck to all.
Market potential of Germany approval in EU market
I am following this board since early January when I start building my position on NWBO. Since I have learn a lot from you guys, I decided to participate my thoughts since I am European and maybe can disclose some facts about markets here and the real market potential of German approval.
Fist of all I am not native speaker, so please forgive me spelling and grammatical mistakes. My background is IT business solutions. Among different consulting and management jobs I have been also working very close with the European IT company providing document management systems for handling drugs approval processes for global pharmaceutical companies, so have a bit of understanding of complexity and country specifics of approval processes.
My general conclusion out of public communications and articles regarding NWBO-Germany case in USA and forum debates is that either isin the financial community there is a huge lack of understanding of Europe as a pharma (and biotech) market or major stock manipulation is going on by those who have that understanding. Let me give you some reasons why I think so.
Europe as a market in general
Europe used to be in comparison with USA in general rigid and byrocracy as a union of states
European Union is slowly but firmly changing that
Legislation is central directed (not that country have same legislation but have to follow the same directions One of the EU regulatives aiming itoward higher
Among top ten countries as per regarding GDP you have 5 Eu countries (Germany, UK, Italy France, Russia)
Considering number of people as per 2013 in European Union lives 500+ mio (without Russia) in USA lives 315+mio people
The economy of the European Union generates a GDP of over €12.894 trillion (US$16.566 trillion in 2012) according to Eurostat, which makes it the largest economy in the world if treated as a single economy.
Europe as a market is still fragmented, different languages, different habits, legislation, wealth distribution, habitants buying power, etc.
European pharma and healthcare market
European union defines directions, legislation is local also considering new drugs approvals. In practice that means that company XYZ having approval in Germany can on faster track goes for approval in Poland
USA in general and also for biotech used to be offering businesses better conditions for new technologies, startups, etc regarding all aspects – EU is catching up very fast lately, with more flexible legislation, etc in each and every field
Approval processes are not the same as in USA. FDA approval is approval only for USA market and not for EU markets (of course it helps, but is not neigher precondition)
Healthcare insurance system is much more social oriented than in states (ObamaCare tries to follows the principles build in EU healthcare insurance systems)
Based on the lattes EU legislations synchronization the healthcare insurance and healthcare systems among EU member are becoming more integrated. Let me give you an example; someone living in Spain and having Spain healthcare insurance can under the same insurance policy take a hospital treatment in Germany if the local healthcare system does not provide that treatment (of course that have to be recommended by a doctor and medical institution)
I will not do the calculations of potential annual sales opportunities or market capitalization or stock price target assumptions, please do your own math, but let me summarize some conclusions:
FDA procedures do not count for EU countries drug administration authorities (there is 28 of them only in EU members), applications of EU legislation directions in one country does count for other EU members.
German approval could means domino effect in EU member countries in like 1-2 years.
There are certain number of ways how to receive heath treatment for deadly diseases anywhere in Europe (I am Slovenian and personally know or has know people with cancer, receiving treatments in Swiss, Germany ,UK, etc)
Germany counts for like 15% of European Union population (Russia has 143 mio, there is also Swiss and Scandinavian countries, etc who are not in EU – all together over 740 mio)
European Union market alone is larger than USA by approximately 60% considering number of people (without Russia).