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TOPIC: Japan Legislation

Japan Legislation 25 Nov 2014 11:08 #2782

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With Passage of japan legislation and interpretation by mesoblast referred to below by Jason Kolbert, even the idiots at Cytori will probably understand the legislation within a couple weeks and have a comment. hopefully will provide some revenue for cytori in time to bump up price above $1 to avoid delisting and avoid reverse split. Unlikely but anything is possible.


November 25, 2014Legislation in Japan Passes
ATHX, CYTX, KOOL, NBS, PSTI
Summary:
We have reviewed a press release from Mesoblast that gave us insight into new Japanese legislation (PMD Act). We paraphrase the data from Mesoblast, emphasizing the data is from Mesoblast and not based on our own independent second source:  
Conditional product approvals will be based on existing Phase II trial results demonstrating probable efficacy and safety with bridging studies in Japanese patients.
Conditional approvals will allow sales of each product candidate for up to 7 years.
Conditionally approved products will be covered by health insurance.
Conditional approvals will cover allogeneic cell therapy product candidates manufactured under GMP outside of Japan; and full approval is expected to require further confirmation of safety and efficacy in a larger population.
Conclusion: We believe the legislation (as stated from Mesoblast) represents a best-case scenario for companies like Mesoblast, Pluristem, and Athersys (allogeneic players), as well as autologous companies like Cytori and others (Cesca and NeoStem).
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Japan Legislation 25 Nov 2014 12:05 #2783

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Thanks Michael-

Yes this date- November 25th- has been known for over 6 months as being the date when "it" all starts. Still I have not thought about it at all until your post. :yep:

One can reasonably be assured that this is the reason why the "live" show is scheduled for December 6th. As written before- Cytori is likely NOT to fall under the law, but obstacles which existed prior to the signing of the law, will disappear and new studies are more than likely.

In respect of approvals and conditional reimbursement- MSB expects their first such "new law" approval in H2 of 2015. And that should be the Osiris application- GvHD. They say they are looking for Japanese partners for their apps which are at the completed Phase II stage and name lower back pain (spinal disk) and CHF (60 patients) as their prime candidates. See the PDF attached. :KO:

They have not found any partners yet (have one for GvHD) and surely have been trying just like the rest of the cell Companies.

This will be interesting going forward- with PRECISE and ATHENA combined -PLUS the other cardiac data which is still hidden (for instance - the young lady from 2009 who could not "communicate" with her husband, later became mother of a beautiful baby) I think Cytori will qualify for reimbursement for cardiac sooner than anybody thinks. ( :vegas: :vegas: :vegas: )

It is sad the way things went in the past two years and long term shareholders were taken to the slaughterhouse by Calhoun AND Hedrick. But all in all the Company (I think) is better positioned than ever- and the tech works- as we know. :nice: :bye:
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Japan Legislation 25 Nov 2014 12:31 #2784

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One thing I am interested in is what they mean by "bridging studies". Does this mean that, for example, if and when ATHENA pans out, they can do some extra trials for Japanese patients and then it's approved?

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Japan Legislation 25 Nov 2014 13:11 #2785

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One thing I am interested in is what they mean by "bridging studies". Does this mean that, for example, if and when ATHENA pans out, they can do some extra trials for Japanese patients and then it's approved?


:grin: :grin: Agamemnus.. you are a smart cookie.

Let me keep it simple. This is most likely the Japanese strategy to "stay in control" and not give any Company the "moral right" to be a player on the Japanese market after they have done a Phase II elsewhere in Europe or the US. No- pass the local barriers too before you get the OK to market your treatment. For that reason it most likely will be a major advantage to have treated Japanese patients like Nagoya and many other Universities in Japan already have for Cytori.

Prime example for that thesis. :winky: :bash:

Back in 2004 MacroPore (the Company name before the name change in 2006 to Cytori) sold its world wide rights to a 510K approved product- SurgiWrap to another Company, but with an exception for the Japanese market. The price would be increased if MacroPore would achieve Japanese Class I approval for SurgiWrap.
The product itself was a bioresorbable thin film wrap, which you put in between organs after surgery, so that those body parts do not "glue to each other". Works perfectly in all races- in white, black, red, pink, yellow and all other types of US citizens. :whistle:

Problem was however that Genzyme already had a product on the market in Japan (Seprafilm) very similar and had a Japanese partner- Kaken- which sold 100 Mio $ annually of that stuff. Of course, they found a Japanese official who said to MacroPore, you have to prove the efficacy of your SurgiWrap also in Japanese man and women. :grin: :KO:

Get my drift????

Actually MacroPore/Cytori did another successful clinic in LA treating patients of Japanese ancestry... that still was not enough...SurgiWrap NEVER got approval in Japan and 2 years ago (after 8 years of effort) this was recognized by Calhoun and Genzyme or better Sanofi is still laughing..... :evil:

Conclusion of the story... take it easy, the Japanese are in this too.... :bye:

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Japan Legislation 25 Nov 2014 13:28 #2786

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I see. Interesting. Thanks. :vegas:

Reading again the earnings report, I see they are in talks to do a new urinary incontinence trial in cooperation with Nagoya. But they already did an 11 patient study which showed safety and a high degree of efficacy back over a year ago.

So to clarify, is that a Phase II trial, since it showed efficacy? Can they not use that 11 patient study right now to initiate large amounts of sales, or is it considered a Phase I?

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Japan Legislation 25 Nov 2014 13:51 #2787

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So to clarify, is that a Phase II trial, since it showed efficacy? Can they not use that 11 patient study right now to initiate large amounts of sales, or is it considered a Phase I?


As mentioned now several times before- Cytori is a device Company NOT fitting the bill for the new law. sigh... :bang:

From that perspective- i.e. the one from the new law, your question has no relevance or meaning.

It all depends what the outcome is of the discussions Nagoya, Cytori, MLHW.

If the Japanese healthcare system is willing to finance an additional study on this indication, one might think this would be beneficial, dont you think???????

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Japan Legislation 25 Nov 2014 14:04 #2788

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fas wrote: As mentioned now several times before- Cytori is a device Company NOT fitting the bill for the new law. sigh... :bang:

Wait, what? My head just exploded. :bang:

If the Japanese healthcare system is willing to finance an additional study on this indication, one might think this would be beneficial, dont you think???????

Sure. But this needs to translate into sales, not just another study...


So, what exactly does Cytori (immediately) gain when the new law is official? General stem cell acceptance? More movement on the urinary incontinence trial, something else? :KO:

Edit: you mentioned something about cardiac... ATHENA, right? And somehow that DOES fall under the law.. or...?

Edit 2: so are you saying that the new law will mean that non-medical-device companies will have a competitive disadvantage against Cytori?

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Japan Legislation 25 Nov 2014 14:34 #2789

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So, what exactly does Cytori (immediately) gain when the new law is official? General stem cell acceptance? More movement on the urinary incontinence trial, something else? :KO:


Obviously - if I knew the answers to the problems of this world, I would be a rich man- and I am not. :whistle:

As mentioned before- the "live" broadcast on December 6 " will surely provide some answers- I think you will hear of some indications, which "suddenly" become close to market due to translational studies already performed and some will be put in motion with the same ultimate goal.

Time will tell- but this date, December 6 will be interesting for the humbled Cytori investor. :really:

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Japan Legislation 25 Nov 2014 14:43 #2790

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Japan Legislation 25 Nov 2014 14:53 #2791

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Thanks Stevie.

Yes. The 6th is a Saturday and obviously wrong. Next Thursday hopefully we will be somewhat smarter.

To recap- images from past presentations on number of clinics...


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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Japan Legislation 25 Nov 2014 22:27 #2792

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***already did an 11 patient (SUI) study which showed safety and a high degree of efficacy***

Really ?
What was your conclusion on the reported result.....was it meaningful worthwhile result in your opinion ?

The Japanese government is so impressed they are allowing Cytori fresh off narrowly avoiding BK to supply all the celutions and consumables at their own cost. A country more than a quadrillion Yen in debt... you would think the cost of a few consumables wouldnt matter to help their citizens !

As Fas suggested...this likely opens more studies and we know that revenue path.

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Japan Legislation 25 Nov 2014 23:10 #2793

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myownhedgefund wrote: Really ?
What was your conclusion on the reported result.....was it meaningful worthwhile result in your opinion ?

Meaningful? What I saw, yes. Here is the full paper: http://onlinelibrary.wiley.com/doi/10.1111/iju.12266/full .

The Japanese government is so impressed they are allowing Cytori fresh off narrowly avoiding BK to supply all the celutions and consumables at their own cost. A country more than a quadrillion Yen in debt... you would think the cost of a few consumables wouldn't matter to help their citizens !

Japan buys plenty of stuff even though they can't pay. :woohoo:

As Fas suggested...this likely opens more studies and we know that revenue path.


My opinion is that they have started taking a more focused approach recently. However, all small cap biotech, especially stem cell stocks, have taken a huge beating this year, no thanks to well-financed short sellers (with some paid cooperation from sites like "The Street") who continue to destroy stocks and companies.

We know that stem cell technology, and Cytori's technology, absolutely works, on a wide range of indications. The company needs to be more proactive in reaching potential investors with the kind of facts that scream "buy me!", and if that happens, they will drive out short sellers and their teams of paid bashers very rapidly.

You just have to watch at how some companies are adept at the money game and some aren't. It's not just about technical prowess in the medical field but also about financial savvy. You saw that with Athersys: they raised a huge sum of money on their rally early this year. On the other hand, Cytori chose pretty much the worst possible time to get more financing. But most of that pain is reversible (they can return the money) if the share price can climb back and they can either get large orders or a decently priced secondary. I believe that ATHX is vastly undervalued... if their current trial is a success, it should see in the near-term. I also believe that CYTX is vastly undervalued -- even more so than ATHX.

What made me buy in is that I believe the financial problems are completely reversible (and they are moving greatly forward on this), and that the technology works. (80% of the October dilution is reversible)

What I would like to see is more of that financial savvy that I have been seeing -- perhaps a breakdown or analysis of their CTX-2 system price versus the current system. This will turn into stock price performance.

I found this recent article (posted today!) which holds a similar view:
http://seekingalpha.com/article/2711865-cytori-why-this-undervalued-cell-therapy-biotech-is-a-buy

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Japan Legislation 26 Nov 2014 09:16 #2796

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The biggest news out is REIMBURSEMENT by the health care system. I can tell you that the people at Cytori did not believe that Japan would offer reimbursement as part of this legislation. This news is somewhat of a surprise to them as their experts seem to have got this wrong. Athersys , on the other hand, was counting on it. The difference between a conditional approval with private pay versus public reimbursement is the difference between night and day. It is not clear to me however, if the PRECISE and the abridged ATHENA data will any value in this regard. If Cytori could convince Japan that their cummulative cardio data meets the critria of the legislation, safety and probable efficacy, a partner would be easy to find because it would be a cash cow with public reimbursement.

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Japan Legislation 26 Nov 2014 09:33 #2797

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OK...so the average 80 year old in Japan with SUI will be willing to under go this procedure....which we have heard complaints about in lipo recovery in ATHENA....to still leak a average 12cc of urine a day. Just for a reduction in diaper use. Also note in Japan they must pay 30% of the cost and insurance (when / if granted ) would pay the rest.
Obviously I disagree this will be big given current results.....they need to improve results or imho the market will be very limited. :whistle:

Second point was not that they still buy things in Japan...I agree...the point was they are LIMITING funding for this expanded study and Cytori has to pick up the tab if they want to proceed !!!

Third point....studies dont get us cash flow positive...that means more cash burn in a company with (as always) very limited resources. CFO calling for flat revenues for 2015. that means they need another 24 million or so just to stand still on the already pathetic balance sheet.
BTW...we havent "proven" anything yet...we have indications but proof is required for FDA approval and insurance reimbursement...of which we have neither.

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Japan Legislation 26 Nov 2014 10:41 #2801

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I can tell you that the people at Cytori did not believe that Japan would offer reimbursement as part of this legislation. This news is somewhat of a surprise to them as their experts seem to have got this wrong.


Ray- where did you get that from? I believe Hedrick also stated that SUI would be able to get reimbursement rather soon.

Anyway- on cardiac. MSB has its 60 patients CHF data. I do not know if that convinces anybody but you never know. Cytori as a device company would be very close to that (24+31=55 patients on PRECISE and ATHENA together)

Obviously TEVA is busy now with the 1720 patients US trial but that will take ages. In the EU the 225 MI clinic is ongoing, but not finished.

I hope Athersys gets good results from stroke- but the requirement to prove in "Japanese" patients should not be under-estimated... :grin:

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Japan Legislation 26 Nov 2014 11:22 #2802

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Fas,

I'm not talking about any particular indication but Marc specifically responded to me in July 2014 emails about reimbursement related to the new Japan legislation. I was actually planning on doing an article about it back then but backed off because Cytori's position was that conditional approval WOULD likely NOT include reimbursement. He actually offered to put me in touch with their expert, Ken Kleinhen, but I declined and just dropped the topic. All along Athersys was expecting reimbursement to be part of the new law and, as it turns out, they were correct: seekingalpha.com/article/2713165-athersys-could-benefit-immensely-from-japan-reimbursement-on-stroke?v=1417017147

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Japan Legislation 26 Nov 2014 11:56 #2803

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Thanks Ray for the answer, although it does not make sense to me. I do trust you more than the management of Cytori.

Conditional product approvals will be based on existing Phase 2 trial results demonstrating probable efficacy and safety with bridging studies in Japanese patients.


is straight from the article that you wrote for Seeking Alpha...

Do not under-estimate the line in bold - it does mean additional work for any Company with Phase 2 results IMHO.

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Japan Legislation 26 Nov 2014 12:36 #2804

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Fas...do we have any estimates on the number of cardiac patients treated in the translational studies that perhaps can be used. I thought at least one of these was Japan specific in patient population.

Cytori management seems to still have a very limited view as to what this new law will actually do for them. With no plan, limited cash and no partner I guess we cant lame them. Much weighs on a part-time employee !

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Japan Legislation 26 Nov 2014 12:42 #2805

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myownhedgefund wrote: OK...so the average 80 year old in Japan with SUI will be willing to under go this procedure....which we have heard complaints about in lipo recovery in ATHENA....to still leak a average 12cc of urine a day. Just for a reduction in diaper use. Also note in Japan they must pay 30% of the cost and insurance (when / if granted ) would pay the rest.
Obviously I disagree this will be big given current results.....they need to improve results or imho the market will be very limited. :whistle:

Well, first of all, there's that 60% reduction number for the 8 patients for whom this was effective, one of whom achieved complete recovery. Two patients had significant cancer-related surgery beforehand, as well (possibly the ones for whom it wasn't effective?). I would absolutely do this operation if I had no other alternatives and was offered.

Second point was not that they still buy things in Japan...I agree...the point was they are LIMITING funding for this expanded study and Cytori has to pick up the tab if they want to proceed !!!

I see. Where did you read this?

Third point....studies dont get us cash flow positive...that means more cash burn in a company with (as always) very limited resources. CFO calling for flat revenues for 2015. that means they need another 24 million or so just to stand still on the already pathetic balance sheet.
BTW...we havent "proven" anything yet...we have indications but proof is required for FDA approval and insurance reimbursement...of which we have neither.

I agree, I agree. We need those phase II trial results to start rolling in. However, I do think that the estimates for 2015 are extremely conservative estimates by Cytori that assume almost no deals get done.

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Japan Legislation 26 Nov 2014 13:17 #2807

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There will always be cases in which the current SUI results will seem appealing to someone.
At one time some estimated a 60 billion dollar market potential...these results say NOT A CHANCE !
You seem excited that the results show 7 of 8 will still need a diaper.

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