Welcome, Guest
Username: Password: Remember me
General
  • Page:
  • 1
  • 2

TOPIC: Regulatory news Nippon

Regulatory news Nippon 08 May 2013 15:48 #440

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3336
  • Thank you received: 1115
I just wanted to turn myself in early today (its father´s day in Germany on Thursday- May 9th- so have to get up early to enjoy preferential treatment) but surfed by Yahoo MB.

WSTs post is extremely important I believe and will be a "facilitator" for the science-

Japan to offer fast-track approval path for stem cell therapies
The following user(s) said Thank You: joeycav11

Please Log in or Create an account to join the conversation.

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:

Regulatory news Nippon 09 May 2013 09:48 #441

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3336
  • Thank you received: 1115
Just to clarify this a bit- RESTORE I from 2006/7 was a study (20 plus patients) conducted by Japanese investigators (Sugimachi and Kitamura)- see RESTORE I followed by RESTORE II mainly in the UK, but also Belgium and Spain. Cytori already indicated that they see chances for reimbursement before the UK news came out, so I believe they definitely already comply to the requirements for this app.

Maybe also for CI , but that is much more unlikely, since not much work has been done in Japan itself, except some cases at Kanazawa and a few other HF patients.

Of course SUI will come next- to me that is a sure thing- it works wonderfully- and therefore just is a matter of time. :grin:

Please Log in or Create an account to join the conversation.

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:

Regulatory news Nippon 09 May 2013 11:45 #443

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2824
  • Thank you received: 202
Hi Fas

I saw WST's post on the YMB as well.
I agree CI is likely a streach and mentioned on the YMB that SUI seemed more probable.
As for breast reconstruction reimbursement in Japan....Cytori has gone quiet on that one after the UK failure added to their long list of other failures.
With what appears to be a customerary 30% cost to the patient tab...I wonder how many of Japans elderly can foot this bill vs living with the inconvience of diapers. So while there certainly will be a market....I guess what I am saying is how big will it really be ?

BTW...Happy Father's Day Fas !!!!!!!!!

Please Log in or Create an account to join the conversation.

Regulatory news Nippon 09 May 2013 17:08 #444

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3336
  • Thank you received: 1115

With what appears to be a customerary 30% cost to the patient tab...I wonder how many of Japans elderly can foot this bill vs living with the inconvience of diapers. So while there certainly will be a market....I guess what I am saying is how big will it really be ?


Good question- but have no idea.

I only know that if I had something like that- and had to pay say 3000$ , I would jump for it. I think approx. 30-40% of the Japanese population would think the same- but might be off...

Please Log in or Create an account to join the conversation.

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:

Regulatory news Nippon 14 May 2013 08:40 #457

  • joeycav11
  • joeycav11's Avatar
  • Offline
  • Expert Boarder
  • Expert Boarder
  • Posts: 130
  • Thank you received: 41
Hedge so you are saying that instead of paying 3000 for this procedure you would sit in your own piss?.... oh my!

Please Log in or Create an account to join the conversation.

Regulatory news Nippon 14 May 2013 09:07 #458

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2824
  • Thank you received: 202
Certainly $3,000 is qiute chep for me....but you are not reading the discussion correctly....how cheap is it for the average Japanese person with SUI who is say 80 years old or more. I do not know. Lets say they have also dealt with the diaper thing for the last 3 years. Inertia can be a funny thing with the elderly and a 3K tab on top of it may or may not be a issue...certainly for some it will be. Maybe family can foot the bill for them.

With what was at one time projected to be a 96 BILLION world market...as Fas said...30-40% isnt too shabby...what the break out % for Japan is I just dont know....but the have a very large elderly population.

Please Log in or Create an account to join the conversation.

Regulatory news Nippon 15 May 2013 10:38 #459

  • fatboy
  • fatboy's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 416
  • Thank you received: 77
When you factor in the longevity of the Japanese population, and the increase in urination's in relation to age, I would think the savings in diapers alone would make the payback on the procedure very short indeed.

Please Log in or Create an account to join the conversation.

Regulatory news Nippon 15 May 2013 10:59 #460

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2824
  • Thank you received: 202
The cost savings in diapers is a valid point fatboy but when dealing with the elderly what seems simple and straight forward logic isnt always the case...even when a procedure is very very simple and completely free. I would again mention what a chronic issue does to the pyscology of a individual with respect to acceptance and fatalism, ect.

This should be a very large application for Cytori to address...I am not worried about that.
What was my recent surprise was, is what seems to be the individual cost to the elderly population in Japan for their healthcare and what role would that play in their decision for a elective procedure.

Please Log in or Create an account to join the conversation.

Regulatory news Nippon 15 May 2013 12:05 #461

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3336
  • Thank you received: 1115
Hedge- I have been busy with all kind of stuff and have not been paying attention as I maybe should:

With what appears to be a customerary 30% cost to the patient tab...I wonder how many of Japans elderly can foot this bill vs living with the inconvience of diapers.


where was this info? you have more of that stuff?

In the CC I noted a remark by Hedrick to Brozak also- if you want to know more about the regulatory rules in Japan, let me know. You should drive that stuff.

Well- I think Brozak should not be driving that- WE-US-SHAREHOLDERS should.

If there is a volunteer to be INSISTENT on Baker/Hedrick - that would be nice. With the new ruling in japan coming up, this is VERY VALUABLE INFORMATION .....(imo)

Please Log in or Create an account to join the conversation.

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:

Regulatory news Nippon 15 May 2013 14:01 #462

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2824
  • Thank you received: 202
Hi Fas

***30% co-pay generally required under Japan's national insurance plan***

This is in the article posted by WST on the YMB on the fast track possibilities and I believe you linked here.
It was news to me...thats not a small figure...of course I am used to the outrageous bills here in the USA :(

As far as a board shareholder advocate....great idea...in some respects DOV has kinda filled that role in the past...at least with sharing info he has learned. Problem is getting answers and then the quality of those answers. Despite Deans talk...Cytori isnt what I consider shareholder friendly in the info area.
The following user(s) said Thank You: brisauto1964

Please Log in or Create an account to join the conversation.

Regulatory news Nippon 15 May 2013 15:20 #463

  • fatboy
  • fatboy's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 416
  • Thank you received: 77
Wow Hedge you really are serious about this stuff. Can't even tell a piss joke? Or were you one step ahead of me? In which case I applaud your deft use of subtlety. Some humor in the arena is called for considering the performance of our stepchild bio tech orphan.

Please Log in or Create an account to join the conversation.

Regulatory news Nippon 15 May 2013 16:31 #464

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2824
  • Thank you received: 202
***Some humor in the arena is called for considering the performance of our stepchild bio tech orphan. ***

There is no denying that !!!

Please Log in or Create an account to join the conversation.

Regulatory news Nippon 16 May 2013 12:35 #465

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3336
  • Thank you received: 1115
Just to complete the theme here (although I think it will be subject of a lot more discussion going forward, because of its importance)-

just the note that I posted a blog entry on the subject- The Japanese are getting it right

about the discussion I had at LinkedIn on this

Please Log in or Create an account to join the conversation.

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:

Regulatory news Nippon 16 May 2013 15:53 #466

  • rongside
  • rongside's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 387
  • Thank you received: 196
Fas, found your blog piece on Japanese regulatory changes very interesting and informative. Early adoption follwed by positive results may very well be the catalyst that forces the US authorities to pick up the pace. Keep up the good work in keeping us informed and spreading the word on CYTX.

In your blog piece you say : "Fact is Cytori has been reporting several of these "specific device claims", without disclosing the related clinical data, which is not illogical, if one assumes that Cytori becomes the owner of the claim as a result of studies with Celution, but the claim developer owns the clinical data. At one point in time ( I assume when reimbursement is almost assured) they will get together and market the therapeutic application together or Cytori provides a license. ".

This comment raises a number of questions eg.
1. To what extent has CYTX given up rights to market independently for approved indications if a third party has been responsible for generating the data that led to the approval?
2. To what extent are they familiar with the data that generated the CE approvals?
3. Are they obligated to partner with the data owner? Even with educational/hospital institutions? (Haven't most of the trials really been about practice of medicine on the part of the clinicians?)
4. What comes first, the chicken or the egg....... reimbursement claims or joint application/license ?
5. Fourty translational studies ........ fourty potential partnerships .......... Is this the reason CC alluded to multiple contract negotiations?.......questions, questions? :bash:

Please Log in or Create an account to join the conversation.

Regulatory news Nippon 16 May 2013 22:35 #467

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2824
  • Thank you received: 202
I read your blog on Japanese progress and LinkedIn post...very nice.

But being a bottom line kinda guy I still see us needing more than the often teased 35 million even when I factor in BARDA and a June miracle in Japan.


Would you agree with this ?

Please Log in or Create an account to join the conversation.

Regulatory news Nippon 17 May 2013 06:04 #468

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3336
  • Thank you received: 1115

This comment raises a number of questions eg.
1. To what extent has CYTX given up rights to market independently for approved indications if a third party has been responsible for generating the data that led to the approval?
2. To what extent are they familiar with the data that generated the CE approvals?
3. Are they obligated to partner with the data owner? Even with educational/hospital institutions? (Haven't most of the trials really been about practice of medicine on the part of the clinicians?)
4. What comes first, the chicken or the egg....... reimbursement claims or joint application/license ?
5. Fourty translational studies ........ fourty potential partnerships .......... Is this the reason CC alluded to multiple contract negotiations?.......questions, questions?


Excellent questions- as usual John.
Problem is- only Cytori can answer them. One thing is for sure- with clinics done with Celution- the claims right falls to Cytori. I have at least asked Calhoun that twice and both times he confirmed. VERY STRONGLY even.
Another thing is for sure- nothing in this world comes for free and without cause. Especially when it concerns disruptive technology that some folks prefer not to succeed. In that respect- Saad told me a while ago- they try certain things with the Notified body and sometimes it works and sometimes it does not. Those fairy tales of that guy make me absolutely furious. :bang: I do hope I never have to deal with him again, but that sentiment I have already since 2007. In my last conversation- he more or less "sneeked" himself in.

Anyway- if it is really true that virtually all studies have been funded by governments and charitable institutions like the Radiation Injury Consortium, we do have a bit of a problem, since marketing needs a financially strong partner going forward and the claims developers- whoever they are- probably require some piece of the cake beyond the scientific recognition of being allowed to produce the scientific peer reviewed papers.

The riddle will be solved sometime- I do have comfort that the assumptions in the blog piece and what I have been writing for years- is dead on. :cool:

Hedge- agree. partner or secondary (ies), what we have known all along.

Please Log in or Create an account to join the conversation.

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:

Regulatory news Nippon 19 May 2013 14:01 #471

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2824
  • Thank you received: 202
***Hedge- agree. partner or secondary (ies), what we have known all along.***

Just to clarify Fas, what I was saying was if we are talking 35 million area for a partnership... I believe we will need either additional partnerships or a secondary in addition to the partnership. Not sure if that was what you were agreeing with or not. Hopefully...if we get a decent partnership done very soon and the PPS reacts we could get better pricing on a secondary and Saad wont wait until we are desperate to raise the funds as he always seems to do !!!

The long road remains imho.

Please Log in or Create an account to join the conversation.

Regulatory news Nippon 20 May 2013 10:50 #473

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3336
  • Thank you received: 1115
Well Hedge- no I was not agreeing to that.

I just do not know- as probably the most knowledgeable Cytori-expert, I only have to admit, that to me the Company is a BLACK HOLE to me.

1. I know they are focused on getting to the coffers of BARDA. But what does that mean? How much of the money coming from that source can be spent on general operations? Do they expect early device sales after entering Phase 2? No idea, about the answers.

but 2. absolute key is Japan. I think if the legislation gets approved before June, I think their is a good chance that some of the CYTX apps will be first to enter the market there- breast recon, radiation wounds, maybe even SUI.

The timing thereof is a big question mark, but COULD surprise us. :yep:

Please Log in or Create an account to join the conversation.

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:

Regulatory news Nippon 20 May 2013 11:33 #475

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2824
  • Thank you received: 202
I think it was on the YMB I was saying not long ago that BARDA was a big unknown as far as how much is free cash that can actually extend the run way. Cytori has touted that it will take up some of the fixed expenses as employees do BARDA work. Its still a unknow how much this slows the burn...and what were these employees doing before BARDA that they wont be doing now ? Since there are so many unknowns I have chosen to focus beyond BARDA...simply because...eventually even if fully implimented the funding ends.
So how do we get to 15,000+ treated patients a year to break even or as Calhoun said profitability. ? It will certainly need some reimbursed application, perhaps several. Can Japan provide this kind of a number in say 3 years ? At a 30 milliom+ year burn rate we need at least 90 million from some where...I think it is more than 90 million.

BARDA takes up some slack.
Potential 35 million take up some more
Maybe the load extension, if sucessful, buys some time
Secondaries and perhaps warrant conversions bring in more $

On the added cost side:
There is still the loan that has to be repaid somehow
We owe Olympus
We owe Senko

Also:
More shares will mean more treatments needed to get to break even
The translational studies will end at somepoint...maybe to further trials which helps some on sales...reimbursed proceedures still a long way off
Puregraft sales grow but really add little
Maybe Japan come thru in June....but Cytori has never been lucky with timing on their side (hope for a upset...LOL)

So to sum up....no matter what...in the end we need large and continous usage to remove the shadow overhanging the stock imho.
Just too many unknows and a lot of cash to come up with over the next several years. :bash:
We need something to break this perception.

Please Log in or Create an account to join the conversation.

Regulatory news Nippon 20 May 2013 13:07 #476

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3336
  • Thank you received: 1115

We need something to break this perception


I agree to that.

Mind you- I have seen some slow improvements- the adaption of immune modulation in the virtues of the cells was important to me (100% Hardcore !) the Q&A at San Francisco- and the following presentation in San Diego, with some regulatory stuff. Thereto the slide that I have on the Front page now.

Whats missing is showing the pathway to the Inflection Point- we said that 6 months ago too and it still is key. Problem is CC than has to take his pants down on the translational stuff and like I said- its difficult to guess what he has hidden there.

Any news on Olympus and Sony?

Please Log in or Create an account to join the conversation.

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:
  • Page:
  • 1
  • 2
Time to create page: 0.125 seconds

Copyright Information

Copyright Fas Kuiters © 2016 young-foxes.com. All Rights Reserved.
This page is made with Joomla CMS and its various templates designed by Fas Kuiters with the excellent Themler tool.

 

 

Shared Spreadsheet Links

DOV´s Revised Projections for the Periods 2017 until 2020

Shareble link : HERE

Fas Kuiters Websites