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TOPIC: Investor note, Dave Musket and Japanese Partner?

Investor note, Dave Musket and Japanese Partner? 17 Jul 2014 12:09 #1880

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Everybody surely must have read the investor note that Cytori published today. As an exception- the information is totally correct and supported by other sources. A MHLW official recently stated- The public comment period for regenerative medicine law is announced sometime this week and the cut off date will be July 31. And than official regenerative medicine law will be announced on August 15 and legislation will be implemented effective November 25.

Also take note that Hedrick DID anticipate this time frame and even was somewhat more conservative and stated in the CC per Nov 2013- but we really won't know exactly what this means probably for a few more months into 2015 and beyond.

The Japanese Diet passed two pieces of legislation in November 2013 that are designed to accelerate the development of regenerative medicine and cell therapies and to create an ‘Early Approval’ process primarily focused on safety. Over the past year, they have continued to refine the legislation, with the intent that the laws will be implemented by November 2014. This legislation includes:

An amendment of the Japanese Pharmaceutical Affairs Law (J-PAL) to include a specific branch for Regenerative Medicine Products. The revised law will be called the Pharmaceuticals and Medical Devices Act
New legislation directing the Ministry of Health, Labour and Welfare (MHLW) to adopt new rules and procedures to enable a streamlined, risk-based approval process for cell therapies

With more than a decade of investment in Japan and an established, Tokyo-based subsidiary, Cytori has a strong stake in the implementation of this legislation and has taken a leadership role in coordinating support for and responding to it. Cytori’s Vice President of Global Regulatory Affairs, Mr. Kenneth Kleinhenz, has been recently appointed to the Healthcare Committee of the American Chamber of Commerce in Japan (ACCJ), the largest healthcare lobby group in the country, and has been a key advocate for the new laws. The ACCJ plans to publish a position paper on the legislation this fall. In addition, Cytori is the only foreign-based company that has a designated member of the Board of Directors for the Forum for Innovative Regenerative Medicine (FIRM), who are also providing support for this new legislation. FIRM is a Japanese organization designed to support advances in regenerative medicine and cell therapy by pursuing industry-led partnerships with government entities and promoting business development and commercialization activities to make these innovative therapies available to patients.

A MHLW-sponsored public comment period for the new regenerative medicine law will be announced soon. During this period, Japanese academics, healthcare industries and citizens can provide feedback on new legislation aimed at regenerative medicine therapies. Cytori is encouraging its customers and key stakeholders to submit feedback to MHLW during the comment period. Following the closing of the public comment period, legislators will review feedback and unveil the final version of the legislation. Cytori will keep investors and other stakeholders appraised of the progress and implementation of the legislation.

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Investor note, Dave Musket and Japanese Partner? 17 Jul 2014 12:22 #1881

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Fas, this was good to see this morning. This is exactly the type of update that shareholders should be receiving on a regular basis. There are so many things going on involving Cytori cellution etc. that if shareholder were kept in the loop, there would be no need for such speculation. I can't help but think this announcement was released because so many shareholders have been reaching out to their management contacts and things have deteriorated so far that this simply could not wait until the annual meeting. Communication with shareholders would go a long way in improving the perception we have of management, as would better execution, and removal of much of the dead wood in this top heavy company. Now if only some real revenue and a decent could be generated due to the passage of this legislation.

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Investor note, Dave Musket and Japanese Partner? 17 Jul 2014 12:35 #1882

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I agree with that Michael. It was good to see and adjusts speculation for realism in the investors mind. I can think of about 20 topics from the past, where this has not been the case and still requires some "final guidance".

But to continue on the topic-

The only participant in Conference Calls which I respect and always hope to be hearing and asking questions is Dave Musket from ProMed Partners- this is his CV:

David B. Musket has been following developments in the pharmaceutical and medical device industries for over 25 years. From May 1984 to May 1989, Musket was an Associate Analyst and then Vice President in the Equities Research Division of Goldman Sachs & Co. sharing responsibility for research and investment banking coverage of the pharmaceutical industry. While Musket was at Goldman, this team was consistently ranked among the top in the industry polls conducted by Institutional Investor and the Greenwich Survey. In 1991 he founded Musket Research Associates, a venture banking firm focused exclusively on financing and investing in emerging healthcare companies. In 1996 he co-founded ProMed Partners, a healthcare-focused investment fund. He is still actively involved with both of these entities.Musket's scientific training included over four years in a doctoral program in Pharmacology and Neurobiology at Cornell University Medical College before he joined Goldman Sachs & Co. His undergraduate education was completed at Boston College (Phi Beta Kappa, summa cum laude). He has served on the Boards of several private and public companies and is currently on the board of TherOx, Inc. Since 2002 Musket has also served as a member of the Advisory Council of the Harvard/MIT Health Sciences and Technology program as well as its Biomedical Enterprise Program.
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Investor note, Dave Musket and Japanese Partner? 18 Jul 2014 06:24 #1884

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So- now that we know who Dave Musket is, we can surely assume that this guy now understands the technology a bit- knows the regulatory pathway (which is rare- hardly anybody understands that) and for all those reasons have been spending "quality time" with Cytori management, in order for his fund to invest in Cytori and for this reason also knows a bit more about the translational work than the average investor.
The following part of the Nov 7 2013 CC shows this quite clearly- I used it already in an article, but there are good reasons to re-visit this piece again.
This time to extract the data which it provides- and draw some conclusions from it-

From Musket´s question:
1.Many investigator initiated clinics are ongoing in Japan, of which the results are due within 12 months (before the end of 2014 and right around the time of the introduction of the new law). The most advanced one should already be completed in Q1 2014.
2.He is assuming that a potential Japanese partner-assuming successful completion of these studies- should be ready to do business BEFORE the new law in finalized :KO: .


From Hedrick´s answer:
1.The NINE or so studies that are ongoing all went through the inefficient and time consuming route of the Stem Cell Guideline Committee. New studies can be initiated much faster. :nice:
2. Regardless of the new law- we will have our own approved and REIMBURSED technology for SPECIFIC indications in Japan
Specifically Hedrick refers to the Nagoya SUI study, which should be very advanced. His statements on that study in the last call in May are simply incomprehensible :evil: .


Dave Musket: Thanks, Marc, that's very helpful. I guess, the – my presumption before all of this effort was that you already met basically the regs to go forward there. You, obviously have several IFPs ongoing and that with the results of those trials kind of being announced over the next 12 months or so, I think some of them, might be even next quarter, that might actually give you much higher profile for – and might push this agenda a little bit more rapidly. In other words, I'm not sure why a company, a potential partner would need to wait because it doesn't look like you would not qualify under the – any of the guidelines that are being discussed. In fact, it looks like you've already met all those requirements.

Marc Hedrick: Yeah, well, so let me take a step back. So we have effectively sort of a device-based approval that allows us to sell this system right now to hospitals. We've got the whole infrastructure in Japan to do that. The problem for us right now in Japan is that we have to – customers that want to do studies have to go through a six to 12-month cycle with a group called the Stem Cell Guideline Committee. You have to do one take and then you apply for your approval, you get your approval and you can treat a certain number of patients and then you can come back and expand that. It's a very inefficient, laborious, time-consuming system. This new legislation will overturn that and then allow doctors to buy the technology and use it without going through the current laborious one-year timeframe. It may even just be a one-day registration. So it can cut our sales cycle time from a year to a day. That could be impactful right away and that's why I'm saying it could have some immediate impact as soon as they overturn that.
The second thing that you really mentioned is, okay, we've got nine or so studies going on, can we take those and convert those into approvals by either taking that data or adding a few more patients and getting formal approval and begin to market it although without reimbursement for that and then set up post-market surveillance studies based on that and then get reimbursement later. And the answer is we absolutely have that as part of our strategy. And if you look at MHLW, the Ministry of Economics and Transport on data, they think that this legislation will cut clinical trial costs in regenerative medicine down by 30%. We probably see more because we hope we're going to be on the lower tier.
And then in the background, we have things that are going on irrespective of this new law, for example, as you know, we have a urology trial that's going, it's multi-center led by Nagoya, which would be geared towards not just early approval, but approval and reimbursement. And so, we're still moving forward on a pathway and we'll talk more about over the next quarter or two to have our own approved and reimbursed technology for specific indications in Japan outside of whatever benefit the new law may have.

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Investor note, Dave Musket and Japanese Partner? 18 Jul 2014 09:23 #1885

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Fas...maybe I am reading the comments from Hedrick wrong but I took his comment as things may have gotten a later start than Musket assumed.

What are your thoughts on that and specifically what you considered incomprehensible ?

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Investor note, Dave Musket and Japanese Partner? 18 Jul 2014 09:32 #1886

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Hedge- I admit English is just one of the languages that I use to converse in- but.....

And so, we're still moving forward on a pathway and we'll talk more about over the next quarter or two to have our own approved and reimbursed technology for specific indications in Japan outside of whatever benefit the new law may have.

To me this statement is clearer than clear... :bash: :bang:

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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:

Investor note, Dave Musket and Japanese Partner? 18 Jul 2014 10:33 #1888

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Maybe it was the presentation...maybe its just me.

The conversations cover the approx. 9 studies in Japan and SUI specifically.

I agree the quote you post is clear...I just dont think the quote in May was all that different.

***And then in the background, we have things that are going on irrespective of this new law, for example, as you know, we have a urology trial that's going, it's multi-center led by Nagoya, which would be geared towards not just early approval, but approval and reimbursement. And so, we're still moving forward on a pathway and we'll talk more about over the next quarter or two to have our own approved and reimbursed technology for specific indications in Japan outside of whatever benefit the new law may have.***

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Investor note, Dave Musket and Japanese Partner? 18 Jul 2014 12:30 #1890

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Hedge-

We are not talking about the same things it seems-

Your quote is the November one- from which I quoted just a sequel from and which was very very positive.... :KO:

THIS HOWEVER came in MAY 2014-

The third is Dr. Momo Gotoh's study. Dr. Gotoh from Nagoya has studied ADRCs with stress urinary incontinence. We originally had positive results from 11 male patients published in the International Journal of Urology in 2013, and more patients have also been treated beyond this.
So MHLW, an arm of the Japanese government, has agreed to fund that study, which should be a pivotal trial in Japan going forward, and we're currently under negotiations regarding the details of that trial with Nagoya University, MHLW and ourselves. And I expect that I will be updating you later in 2014 as we work toward a clinical development timeline for that, and I'll convey that to you when available.


Kind of implying that the study had not started period.

This is totally contrary to prior statements and the experience we have with Gotoh and Yamamoto at Nagoya, who are very competent in driving studies contrary to what we know from Cytori.

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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:

Investor note, Dave Musket and Japanese Partner? 18 Jul 2014 14:01 #1892

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OK...Thats the confusion. I was reading what you pulled as from the May call

The usual miscommunication prevails it seems.

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Investor note, Dave Musket and Japanese Partner? 22 Jul 2014 08:53 #1898

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Fas<
Cytori management team members must check this board as it seems that subjects that we have put on our lists that need to be updated are being addressed in communications from the company. Lorem update , BARDA and new Cardio trial. Would have liked to see explanation on resignation of Lim appointed board member as this happened on the 15th and most banter on Yahoo is speculative and of course negative. Hoping this was really a non event, but an example of a situation that should have been addressed and but to rest immediately. Although communication should be expected as it is not common with CYTX perhaps they are turning over a new leaf. Good to see progress in this area. Now just need to see some monies flow in from monetizing the technology commercially.

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