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TOPIC: New paper from Arnold Caplan & Co

New paper from Arnold Caplan & Co 30 Dec 2013 09:51 #1171

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The works from Caplan are like "bibles" for me and his writings are congruent to what I have seen and learned from different clinics or pre-clinical studies.
I believe this is another monumental piece of work and if you go through it you will understand why Cytori will most likely come out in front, whilst the "others" are still pretty clueless. :cool:

This part I really like:

Culture-expanded versus point-of-care autologous MSC
Because of the initial perception of cells as a drug, doses of MSCs in the thousands, millions or billions based on the recipient’s body weight were believed to be necessary for a therapeutic effect. Such doses are not physiologically compatible with point-of-care isolation of MSCs from BM aspirate, and in vitro expansion of cells was utilized to generate the required cell numbers in a matter of days or weeks. A detail that is often overlooked in this process is the elimination of other cell types (hematopoietic stem cells, endothelial cells and so on) and the creation of a homogeneous cell population with successive cell culture passages. The temporal change and convergent cell phenotype may have an impact on the ‘per cell’ therapeutic efficacy. In addition, the inclusion of other phenotypes in a heterogeneous population of fresh cells may benefit the modulation and vascularization of the targeted tissue. The trade-offs of greater MSC numbers versus unaltered and heterogeneous cell preparations have not been sufficiently explored in the literature.


Nature has created the human body repair processes in billions of years. It most likely knows whats best. :grin:
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New paper from Arnold Caplan & Co 30 Dec 2013 12:35 #1172

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Clearly research has been going on for a long long time. What a painfully slow and frustrating process it has been. I hope the pathway chosen by Cytori is the winner. All that I have learned since being invested here for the last five years leads one to believe that from a cost standpoint and efficacy of treatments thus far leads me to believe that Cytori science is on the right track. Not being a scientist, my observation is that once the new cellution table top models are perfected that another barrier to entry has been overcome. The process has been so painfully slow and I am inclined to believe that it is just a matter of time. I guess only the shadow knows. Thanks fas for continuing to post information that allows the layman an opportunity to understand what is going on. Happy New year and may 2014 prove to be a better year then the disappointing year 2013 has been when it comes to Cytori progress. I do hope the adage good things come to those who wait applies

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New paper from Arnold Caplan & Co 30 Dec 2013 17:22 #1173

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Yes Fas,

Dr. Caplan's belief in the benefits of regenerative medicine is certainly uplifting. Thank you for the information you post on this site. It is always interesting and educational. My daughter defended her PHD thesis in molecular biology at NYU last month and as I listened to her presentation on a very complicated study investigating how a certain protein effected breast cancer cells I have to admit I was out of my league. It did however give me an understanding of the complexities of the science of cells that we are dealing with. In laboratories all over the world experiments are being performed and great minds are working on these problems. Eventually I feel humanity will benefit from the work that is being done. Your belief in ADRC efficacy is heartening. Cytori's concentration on the ability to provide these cells seems to me to be a serious journey that has the potential to help people. As I always say - helping people is the key to all of this.

Happy New Year to you and to all that read the posts on this site.

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New paper from Arnold Caplan & Co 30 Dec 2013 19:24 #1174

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The Injury Drugstore that is MSC plus the assortment of regenerative cells in the SVF were developed during mankind's evolution. Its constituent parts are very powerful, but its systemic/synergistic approach in treating sickness is profound. Minimal manipulation of that which evolution has created to protect us is essential at this initial stage of treating patients.

There are many unanswered questions about the relationships of all these cells between each other and the regenerative process in general. However, a deep understanding of the precise Method of Action, although desirable is not necessary. Safe, statistically significant trials showing material benefit to patients is all that counts at this stage. We have seen material benefit to patients from ADRC in a large number of indications over past years. Lets hope that 2014 brings an increase in the pace of the progress made todate, and that the markets finally appreciate and value this transformative technology accordingly.

On a related note I have been seeing an increased number of articles indicating the effectiveness of simple fat grafting in a number of difficult indications. It makes me wonder whether from a cost benefit perspective if simple fat grafting might not pose a challenge to enhanced ADRC fat grafting. Perhaps PUREGRAF may be more valuable than initially thought.

Specifically on pages 36 and 45 from the below linked document one can see the merits of simple fat grafts in treating hitherto difficult or untreatable indications. The secret to our future success is getting the enhanced fat graft adopted as the standard of care before that of the simple fat graft ............ otherwise we will be competing against ourselves and the cost benefit of the cartridge and reagents will have to be considerably lower than otherwise.

www.ipras.org/sites/default/files/pdfs/IPRAS13.pdf

Also relating to treating old burns with significant scarring is the following trial:

www.ncbi.nlm.nih.gov/pubmed/24036737

Another systemic sclerosis study is very interesting and supports the use of ADRC:

www.ncbi.nlm.nih.gov/pubmed/24152595

I think Dean will be proven correct with his 10XWD forecast. As all good brokers know, you can always predict a price but never set a date for it to be realised. As time passes more data is generated and we progressively approach our 10XWD date ........whenever that may be.

To all Cytori longs, I wish you a Happy and Healthy 2014, and may this year be the one in which our patience as CYTX investors is rewarded. :vegas:
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New paper from Arnold Caplan & Co 31 Dec 2013 08:03 #1175

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Why is it, that when I read Rongside (i.e John) I recognize myself. :winky:

Great to have a brother in arms and thoughts. Thank you John and all the best to you in 2014 too- fortune and most important good health.

Of course these wishes go to all board readers and writers likewise.

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New paper from Arnold Caplan & Co 31 Dec 2013 11:00 #1176

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*** Perhaps PUREGRAF may be more valuable than initially thought***

Too bad we sold it !

Happy 2014 to the lodge !

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New paper from Arnold Caplan & Co 01 Jan 2014 09:28 #1177

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I hope you all came "across" safely and wish you all a happy and healthy 2014. :vegas:

Of course- I urged the person who posted this paper at LinkedIn in a patients discussion group, to post it also in the main group- Lee Buckler´s Cell Therapy Industry Group which now has already 6500 members and is growing fast- i.e. a nice audience for my thoughts and opinions... :nice:

Of course was the first one to respond- I will keep you posted for "important" other opinions and following discussions- :write: :write:

Another monumental piece of work IMO by Caplan et al, describing the state of the industry and addressing a lot of the themes that have been discussed here in this group.
Besides the impressive potential platform of applications for MSCs, especially the last chapter should give plenty food for though for many here.
In this last chapter (Efficacy, Safety and Regulatory status of MSC therapy) Caplan et al deals with the issues "Autologous versus Allogeneic", where he clearly describes the drawbacks of allogeneic as many here have already taken note of. Particularly important I find his observation in "Culture-expanded versus POC autologous MSC"- quote- A detail that is often overlooked in this process is the elimination of other cell types (hematopoietic stem cells, endothelial cells and so on) and the creation of a homogeneous cell population with successive cell culture passages. The temporal change and convergent cell phenotype may have an impact on the ‘per cell’ therapeutic efficacy. In addition, the inclusion of other phenotypes in a heterogeneous population of fresh cells may benefit the modulation and vascularization of the targeted tissue. The trade-offs of greater MSC numbers versus unaltered and heterogeneous cell preparations have not been sufficiently explored in the literature."unquote
That reminded me of a comment of a reader at Knoepler´s blog, who reacted on a statement concerning "contaminant cell populations" in SVF. I do not re-call his exact wording, but he argued that nature had created the human physiology and cellular structure in several billion years. It is quite likely that nature knows better how to deal with injury-, tissue necrosis and other cellular imbalances, than the present day scientists, who simply just strive to create a identifiable biochemical product, which fits all needs and is patentable, of course. I do not think that will work. A scientist from the field who I corresponded with a few years ago, mentioned he would love to study the interactions between the different cell populations in a large animal model. So far- nobody has done that and such would cost about 5 to 8 Mio$. About time some health authority steps to the plate and have some work done.

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New paper from Arnold Caplan & Co 04 Jan 2014 03:45 #1181

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There have been some interesting statements and opinions the last few days- not so interesting that WST (Ray Xerri) believes both allogeneic and autologous will find their way- we knew that opinion already- but this one from jacques Galipeau for instance Professor at Emory-

Arnold has written a very nice piece. His acknowledgment that allogeneic MSC may not be “immuneprivilged” is an evolution of perspective which informs scientific and commercial development. His highlighting the importance of successfully navigating FDA for more-than-minimally-manipulated cells defines the most significant challenging in deploying this technology at large for all those who may benefit [including those unable to join clinical trials].

However, the discussion of whether auto is better than allo is moot. I would propose to this audience is that cost effectiveness to improve QALY [Quality Adjusted Life Years] will trump all, including FDA approval…

A great historical example is the use of autologous chondrocytes. Though not as fashionable as “stem cells”, this product has been navigated through FDA approval by Genzyme as a product called Carticel®. Genzyme divested itself of this business a few years after gaining FDA approval in 2007 ( news.genzyme.com/press-release/genzyme-financial-recovery-continues-fourth-quarter ). From analysis papers available on the net, it seems that top line for this product was $45M in the last year before it was jettisoned.

Why did Genzyme trash Carticel? I would propose that the UK governmental outfit NICE ( en.wikipedia.org/wiki/National_Institute_for_Health_and_Care_Excellence ) is a reason for such. Their analysis of autologous chondrocyte implantation (ACI) was not favorable. Please see ( publications.nice.org.uk/the-use-of-autologous-chondrocyte-implantation-for-the-treatment-of-cartilage-defects-in-the-knee-ta89 )

With the advent of the Affordable Care Act (aka Obamacare), the pressure on reducing cost of medical care as a % of GDP by Medicare/Medicaid and private insurers will be increasing exponentially in years to come. NICE-like panels will be a reality of the future and European panels of this ilk may well foreshadow where cell therapies, including SVF, MSCs CAR-T, etc… will become realities.

Bottom line: the new cell treatments need to make the blind see and the crippled walk if high price points are required to drive business model. Cell therapies that do not deliver the goods (like ACI) will sink no matter what the price point.

So, assuming unimpeachable demonstration of benefit AND applying strict cost/quality control principles in containing costs of manufacturing and delivering goods will be paramount to launch and sustain cell therapy businesses.

I also like the idea of hospital exemption (as they have in UK). This middle of the road pathway may allow for development of technologies on a small (yet affordable) scale for autologous therapies. (As a university-based scholar I must declare my bias here…)

And best of luck to Athersys, Mesoblast, Pluristem and all the other big allo players out there with gaining approval and good QALY assessments on their products/indications!

Hopefully, 2014 will bring some good news on that front.

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New paper from Arnold Caplan & Co 04 Jan 2014 03:47 #1182

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and a statement from one of the authors of the paper- Matt Murphy-

Thank you all for the kind remarks. As a full disclosure, I am employed by Celling Biosciences, a company that specializes in autologous cell concentration at the point-of-care. I also have an affiliated research appointment with the Department of Biomedical Engineering at the University of Texas at Austin. The senior author, Prof. Arnold Caplan, is a professor at Case Western Reserve University, a pioneer of the mesenchymal stem cell field, and a founding member of Osiris Therapeutics, an allogeneic stem cell company. This paper brought together the perspectives of scientists from both sides of the autologous vs. allogeneic coin to provide a realistic overview of the current state of the field.

The intent of the review article was to highlight the strengths, weaknesses, opportunities, and differences between the various types of adult mesenchymal stem cells. Although the clinical data is still catching up to decades of basic science research, there have been published, peer-reviewed, successful human in vivo studies in several areas. Many questions remain to be answered: What are the trade-offs between a high "dose" of homogeneous, but potentially less potent, culture-expanded autologous cells and a lesser concentration of fresh cells? Is there a synergistic or community effect of a heterogeneous population including HSCs and endothelial cells? Do the safety concerns and questionable efficacy of allogeneic cells outweigh their usefulness as an off-the-shelf product? The answers to all of these questions will likely vary based on the clinical pathology being treated and patient-specific factors. However, who will fund the necessary studies to advance the field? Unlike big pharma companies that own IP around specific drug formulations, companies like Celling do not hold patents on autologous stem cells, so there is little financial incentive to fund the research that will benefit their current and future competitors. Unfortunately, adult cell research, especially autologously derived cells, appears to be less interesting to funding agencies than embryonic or induced pluripotent stem (IPS) cell research.

Lastly, the review highlighted the current regulatory environment in the United States to demonstrate that some types therapy (i.e. autologous, minimally manipulated cells used at the point-of-care) are not regulated as drugs and are available today at a physician's discretion as a part of the practice of medicine. As evidence of safety mounts, it is a viable (and affordable) treatment option for many. Perhaps this will reduce patients going overseas for rouge therapies costing tens of thousands of dollars. Together as a field, we must continue to gather and publish data to determine the best source, quantity, and method of application of cells to answer unmet clinical needs.

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New paper from Arnold Caplan & Co 04 Jan 2014 03:52 #1183

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and last but not least- Falk Heinrichsohn-


The statement mentioned by Fas “that nature knows better how to deal with injury-, tissue necrosis and other cellular imbalances, than the present day scientists, who simply just strive to create an identifiable biochemical product, which fits all needs and is patentable” needs to be explored more, i.e. “discovered” not invented, as if invented, its unnatural….but can be patented.
Allo versus Auto should however not be the point of discussion, but how to use and stimulate the body´s own defense and regenerative system and capability by various means to meet so far unmet medical need of patients.
The combination of e.g. PRP and SVF / BM as well as PEMF technologies as mentioned already by me before as an auto treatment has high potential, probably higher than Allo, because Allo cells are usually expanded and as we know by now, cell efficacy is going to be reduced by cell division, as we will loose a part of the telomeres. Probably this is also a potential reason why Allo is less effective when expanded in performed clinical trials.
Therefore, I believe the concentration of SVF / stem cells from BM and platelets administered at the same body without expansion (same day procedure) together with biofeedback and PEMF technology is the most elegant solution for regeneration and healing.


I did not know what PEMF tech is what he mentioned- will look some more in to it but here is a link that explains that a bit-

PEMF tech- pain reduction
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New paper from Arnold Caplan & Co 04 Jan 2014 09:41 #1184

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All the "missed" partner deals slowly but surely give rise in my mind that Cytori tech is disruptive to Big Pharma (although I still think Astellas can come), which led to my reply to Matt Murphy as follows-

Hi Matt. Thank YOU for the nice work and additional elaborations, which were very helpful. I just wanted to comment briefly on the aspect of funding agencies which seems to be lacking for autologous MSC cell therapy. Most folks here already know that personally I am highly intrigued by the potential of fresh SVF and anybody reading your paper will have sympathy for that if they glance at Table 1. My impression is that the biological goldmine-as I call SVF- will not be mined by Big Pharma, but that the funding will come across the globe from health authorities. Reason being the "disruptive nature" and potential of being highly beneficial to a large range of indications and unmet needs (as you describe so eloquently), which cannot be the right thing for most pill manufacturers.
The reverse is probably true for collective health care systems world wide and its no surprise therefore that the national health authorities in places like Germany, France, Italy, UK, Switzerland and several others are already sponsoring clinical studies. And when I do hear that US agencies like BARDA, CDC, Department of Defense and NIAID are giving MSC technology a serious look, my guess will be that this will be the pathway for development. As usual- time will tell.

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New paper from Arnold Caplan & Co 12 Dec 2014 06:54 #2903

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Bump. :yep:




For newbees and oldtimers alike- refreshment on Caplan and his pericyte theories
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New paper from Arnold Caplan & Co 12 Dec 2014 09:28 #2906

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fas wrote: All the "missed" partner deals slowly but surely give rise in my mind that Cytori tech is disruptive to Big Pharma (although I still think Astellas can come), which led to my reply to Matt Murphy as follows-

Hi Matt. Thank YOU for the nice work and additional elaborations, which were very helpful. I just wanted to comment briefly on the aspect of funding agencies which seems to be lacking for autologous MSC cell therapy. Most folks here already know that personally I am highly intrigued by the potential of fresh SVF and anybody reading your paper will have sympathy for that if they glance at Table 1. My impression is that the biological goldmine-as I call SVF- will not be mined by Big Pharma, but that the funding will come across the globe from health authorities. Reason being the "disruptive nature" and potential of being highly beneficial to a large range of indications and unmet needs (as you describe so eloquently), which cannot be the right thing for most pill manufacturers.
The reverse is probably true for collective health care systems world wide and its no surprise therefore that the national health authorities in places like Germany, France, Italy, UK, Switzerland and several others are already sponsoring clinical studies. And when I do hear that US agencies like BARDA, CDC, Department of Defense and NIAID are giving MSC technology a serious look, my guess will be that this will be the pathway for development. As usual- time will tell.




@ FAS.....i agree. Taking my tin-foil hat off and just strictly thinking about the geo-political impact this kind or similar technology can have on the current medical industrial complex in America is literally mind boggling! To have [conservatively] 50% of useless big pharma drugs go the way of the VHS cassette must absolutely worry some. But the reality is, this kind of stem cell treatment can just be the gold standard in capitalistic countries without govt run healthcare systems. Either you can afford it or you cant. I personally think that behind the scenes the power players are loading up on the stem cell moat diggers and they too will ride the wave of capitalistic fever into the new paradigm of medicine.


Anecdotally, it figures our biggest investor to date is Chinese! Imagine if it were a Russian oligarch...with they primary residence being in eastern ukraine!? Oh heavens to Betsy...Cytori would be sanctioned! This world is complicated.....especially for people just trying to make a buck. jeeez
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New paper from Arnold Caplan & Co 12 Dec 2014 16:19 #2913

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Without a doubt, the potential of stem cells is absolutely huge, if yet to be entirely proven. The financial potential of a technology such as Celution is equally huge not only from a therapeutic effect, but also from the financial implications it has for the whole medical/pharmaceutical industrial complex.

We are in some ways fortunate to have been present in Japan and Europe for so long, even if with mixed results. This is because we are visibal and have a proven safety record. These countries/regions because they are bastions of socialized medicine (normally anathema to US citizens) are more likely to find the funding or legislative leeway to further the development and acceptance of regenerative medicine in general, and Celution in particular.

In the last investor event where we could pose questions directly to CYTX management MH answered my one concerning Astellas. He basically said they continued to be an important and active participant/investor. Could it be that they (Astellas) has also been waiting for the new legislation prior to pursuing further its collaboration with us ?

As for CIRM which was mentioned in a previous thread ....... they also have a vested interest in becoming more proactive, with a more applied research approach than in the past. I would hope (and believe) that CYTX is engaged in active dialogue with them.

The FDA's acceptance of a PIVOTAL trial in scleroderma is huge and not well understood by the market. This is an indication that can be the game changer for Cytori's future. I always believed that to be the case. Hopefully CIRM could see its way in funding related trials/research in similar autoimmune disease indications such as rheumatoid arthritis or multiple sclerosis. This would be money well spent !!!!!
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New paper from Arnold Caplan & Co 15 Dec 2014 06:41 #2917

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But the reality is, this kind of stem cell treatment can just be the gold standard in capitalistic countries without govt run healthcare systems. Either you can afford it or you cant.


CCDG

IMO, you make the same thinking mistakes as your original, who always was looking at competition who were planning to ask 30-100k for a shot at their approved therapy. Even with just 10-20% of such prices you simply CANNOT become the paradigm shift in medicine.

Our own body is the "medicine man"- Cytori/Celution just facilitators, of which prices of the razorblade i.e. disposables has to come down as much as the prices of the razor i.e. Celution.

Since BP probably will not develop the therapies- STATE/GOVERNMENT SPONSORED health care systems will. You see it happening with BAMI the 3000 patients cardiac trial in Europe. Thats Bone marrow, but already 9-10 governments are sponsoring Cytori clinics in Europe and elsewhere.

Thats the way to go. Our belly cannot be elite and I believe Okyanos and others can only be successful since they are front-running and the US will lack China, Japan, Europe by many many years.

In the end the easy treatments should be able to be done by the physician at the corner of the street and prices follow the development of any "disruptive technology"-

it comes down whilst maturing....and IMPROVING at the same time :KO:
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New paper from Arnold Caplan & Co 17 Dec 2014 05:25 #2922

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Fas, while I agree with you that a disruptive technology does get better over time with more innovative applications being developed, and the unit cost going down considerably as the benefits of scale appear with product acceptance, lets not forget that the unit price of a pill is infinitesimal compared to its cost. But that doesn't prevent BP from squeezing payers as much as it can.

Needless to say the affordability issue is paramount in the decision making process of the state/government/insurance payers. However it would be nice to keep some premium markup initially to justify the cost of development .......... not to mention allaying the cost of my premature investment in the company !!!!! Managing the product life cycle is very important. Brand/indication expansion should be fun...... eventually. :winky:

As always "early adopters" are the ones who are prepared to pay for the new toy (treatment). Lets hope that the buzz they create (Okyanos, Lorem, Japan, BARDA, Scleroderma etc.) make us as ubiquitous in hospitals as the cell phones in our pockets ! :cool:

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New paper from Arnold Caplan & Co 17 Dec 2014 09:43 #2923

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As always "early adopters" are the ones who are prepared to pay for the new toy (treatment). Lets hope that the buzz they create (Okyanos, Lorem, Japan, BARDA, Scleroderma etc.) make us as ubiquitous in hospitals as the cell phones in our pockets !


If I recall right - those early cell phones were not very cheap at all.

Besides knowing Clayton Christensen and his theories- 45 years ago I was learning stuff from Joseph Schumpeter and his theories are scientifically much wider adopted and accepted.

The early birds made the killing according to Schumpeter and in more protected and organized countries as the US and japan, that hopefully be the case as long as management of Cytori play their hand right this time.... :whistle: :really:

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DOV´s Revised Projections for the Periods 2017 until 2020

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