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TOPIC: HumanitarianDeviceExemption Parry Romberg Syndrome

HumanitarianDeviceExemption Parry Romberg Syndrome 01 Feb 2013 15:29 #78

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www.heraldonline.com/2013/02/01/4587775/doctor-credits-stem-cells-for.html

I viewed the above article and it reminded me that in the past there was mention by CYTX that they would be requesting a humanitarian device exemption for Parry Romberg Syndrome. We have not heard anything about this even though a considerable amount of time has elapsed (surprise surprise). Any idea on whether they have submitted anything to the FDA? Is it conceivable that the FDA does not wish to allow the device into the hands of plastic surgeons for a limited and specific indication for fear that it would be used for alternative procedures???? Is CYTX self censoring themselves having come to the conclusion that you can't fight city hall (FDA)???

Is there any point in asking IR for information concerning the above? I e-mailed them once with a couple of questions and got no response, not even a polite brush off.

On a related point, it would appear that Parry Romberg Syndrome and Localised Scleroderma are related. If so and the French trial for non systemic scleroderma proves to be successful we should have access to two orphan indications ......... whatever that means for the FDA.

www.ncbi.nlm.nih.gov/pmc/articles/PMC2905582/
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HumanitarianDeviceExemption Parry Romberg Syndrome 01 Feb 2013 16:23 #79

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Thanks for reminding again on PRS John.
The second link with the NIH story is particularly revealing and awesome. Terrible how some people have to suffer with neurological issues on top of their appearance problems.
I think we have to go to the bottom of this- am sick of the "hide and seek" or better "none of your business" attitude of the folks responsible for IR at Cytori.
These are important issues even if orphan and limited market potential, but the technology COULD help a distinct population of very sick people and we- shareholders- ought to know.
Wasnt their a slide you referred to that showed that a study on PRS was well progressed and close to completion?
Please help with my re-collection and I will try to get some wheels in motion.
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HumanitarianDeviceExemption Parry Romberg Syndrome 02 Feb 2013 07:12 #80

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Been thinking about this a bit more. Somewhere in the back of my mind is the notion stored that Cytori showed a slide at a conference once, indicating a significant advancement with this indication.
Like just about everything, my hunch is that such development to a therapeutic claim on Celution would likely have been in Europe i.e. UK mainly- just like the approvals for diabetic foot, radiation wounds etc etc.

Now- Calhoun mailed me two weeks ago on the regulatory strategy Cytori is following and basically said- that all the translational work done by third parties leading up to therapeutic claims abroad- mainly EU, will be leveraged elsewhere- like the US- and will be used to go straight into pivotals there (i.e. by-passing pilots to prove the safety and feasibility). This is likely with PRS too.

His wording on this part of the strategy was as follows-

Part B – Investigator led work that has the opportunity to help expand therapeutic claims (like in Europe, maybe Japan) and establish a knowledge base and clinical experience around specific indications to leverage directly into advanced / pivotal trials where needed (like the US). It's a great R&D multiplier while in parallel "designing our technology in" to the clinical world so that the new regenerative clinical approaches utilize cells from adipose as the foundation of their regenerative therapies. Again – we want to set the standard source for the coming age of cell therapy to use Adipose vs everything else – think MicroSoft Operating System vs all the others… This is very evident today – whereas just a few short years ago (you likely remember this) everyone laughed at us bc we were so different and broke all the existing paradigms – so we must be wrong. Today – by far the leading source of cells used clinical around the world is from fat. The clinical world is already defaulting to cells from fat because it works, because it's safe and because it fits in all other categories – workflow, cost, easy of access / use, autologous, multiple cells = multiple mechanisms, point of care, real time therapy, etc etc.


I was wondering John, since you know a lot on the subject- can you write a blog post on PRS? with the past promises of Cytori on the subject and your "best guesses" where we are now on the indication- just a thought- I surely can help with the technical part- and its really easier than you think. ;)
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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:

HumanitarianDeviceExemption Parry Romberg Syndrome 02 Feb 2013 17:19 #83

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Fas, here is the link to the slide 16 of the 2012 Annual Shareholder Meeting Presentation. It shows that the pivotal trial is (almost) complete for soft tissue facial wasting, which I assume refers to PRS.

www.slideshare.net/CytoriTherapeutics/2012-annual-shareholder-meeting-presentation

In previous annual reports (10-k) the company referred to an intent to submit an HDE application for PRS. HDE relates to applications submitted to the US authorities ie. the FDA. One would infer that having decided to go the HDE route that the data for such a submission would be USA sourced. From the slide I infer that the trial is completed, but there is no way of knowing if this was done in the UK or USA. Of course it is more than likely that the trial was undertaken in Europe. Prior experience with PRS is possibly the reason that the scleroderma trial which is a related disease is being undertaken in France.

Thank you for sharing CC's comment about being able to use global (European & Japanese) data to leapfrog directly into pivotal trials in the USA. THIS IS HUGE. If possible/true it will immediately provide CYTX with the opportunity to have a large number of USA pivotal trials covering a broad range of indications that will rival that of any and all of the BP.

As for doing a blog I will think about it. I don't really know all that much about PRS or Cytori's involvement beyond that which is available to all on the net. In my opinion CYTX at one point in time no doubt saw an HDE as an easy way into the US market. They probably now realise that they cannot attack the US market in a piecemeal manner with lots of small joint ventures or partnerships.

They need to get this right the first time. Lets not forget that IBM licensed microsoft MS-DOS software without insisting on exclusivity or ownership of the software. The rest is history, the PC changed the face of computing and microsoft became bigger than all of the hardware producers. Big Pharma does not want to repeat that mistake............. that's what makes these deal negotiations a bitch.
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HumanitarianDeviceExemption Parry Romberg Syndrome 03 Feb 2013 06:22 #84

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This is the slide concerned-

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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:

HumanitarianDeviceExemption Parry Romberg Syndrome 03 Feb 2013 06:24 #85

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And this is an overview of the PI led studies late in 2009 :blink:

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HumanitarianDeviceExemption Parry Romberg Syndrome 03 Feb 2013 07:13 #86

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On the PRS issue, I would think that the "soft tissue facial wasting" is the result of the work started by Akita on HIV induced facial wasting.
Actually in the video on the radiation wound of the old lady he speaks about that work too.

I know for 100% sure the radiation trial (30 patients funded for 15 Mio$ by a consortium and the MLHW) moved to Europe. Probably all those other indications- diabetic foot, chronic (=trauma), burns - was in Germany, got approval in Europe based on externally funded clinical investigations and certainly not "the clinical database" of Cytori as Hedrick keep repeating. Just a small thing- obviously the arrows in the slide were way to short for radiation etc. Pure deception really..

That is why I think Calhoun and especially Hedrick need to go. They have deceived and misinformed the Cytori shareholders now for the past four years and have been hiding the success achieved by the technology, resulting in the therapeutic claims in August.

Nobody apparently understood the August announcement, which I commented on in the Milestones article- tells you most shareholders are not too smart. I know that some of the big shareholders DID understand my article and acted accordingly and for those reasons share my sentiment on Calhoun and especially Hedrick.

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HumanitarianDeviceExemption Parry Romberg Syndrome 03 Feb 2013 07:35 #87

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If one really THINKS about it for a few minutes- anybody with a bit of brain- would realize that the expense involved for achieving those regulatory milestones would run into 100-150 Mio$ and since all were a success, would / should add 200-300 Mio$ market cap to Cytori- in case the events were COMMUNICATED PROPERLY..

Surely Calhoun´s "bad luck" is that the Companies involved in the claims are letting him dangle on a rope- moving those indications into pivotals in the US does not seem to be a priority. I suppose they are more interested to get them on DRG lists in Europe before taking that step.

And that might take a while longer- I would think. :whistle:

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HumanitarianDeviceExemption Parry Romberg Syndrome 03 Feb 2013 09:59 #88

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Actually- I have one more...lol :woohoo:

If you continue "spinning" this thought process, you arrive at a conclusion that management and board possessed "material information NOT disclosed to shareholders", which is of such substance, that their window of opportunity to trade shares in Cytori should always have been CLOSED.

Also for Lloyd Dean, who surely on the knowledge of all this- arrived at his- 10XWD statement. :S

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HumanitarianDeviceExemption Parry Romberg Syndrome 03 Feb 2013 15:54 #90

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Fas

Unless partnered, how would we have moved to pivitol trials in the USA with other indications when CYTX has NEVER been flush with money ?

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HumanitarianDeviceExemption Parry Romberg Syndrome 03 Feb 2013 17:19 #91

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Sure thing Hedge- Calhoun & Co are stuck with those approved indications in the UK.

It is clear to me they "own" the approval or better "claim on Celution", but not the data, since those belong to the guys that paid for/ developed the applications, which you need to put in front of the FDA to move into a pivotal trial.

Nothing will happen until that /those partner deals are signed- sealed- and delivered. B)

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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:

HumanitarianDeviceExemption Parry Romberg Syndrome 03 Feb 2013 18:38 #92

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CYTX obviously has a game changing technology. Unfortunately they do not own the data. They appear to have allowed multiple Investigator Trials to be undertaken without having considered how a deal will be structured beforehand. They are talking to over seven different parties about partnership deals yet we are only aware of two potential partners: Olympus and Astellas. It may be that the trial data from some of the others may be with government institutions, not necessarily only corporates which have a financial agenda to protect. We however need the cash to forward our own trials. We will therefore have to give up a percentage of the market for certain indications to proceed.

The first private sector partnership deal sets the bar. This must be high or we will have problems with the following deals. All potential partners will be interested in accessing the US market but they still have to get over the initial hurdles in Europe and Japan first.How reasonable is it to sign away access to the biggest healthcare market in the world without having substantial compensation. The negotiations have proven to be very difficult but it is in the interests of all parties to get it done ......... technological progress waits for no one.

For me the UK breast reconstruction reimbursement approval is paramount as that will signal to all potential partners that we have a valid technology and substantial positive cash flow expectations. This renders their data less valuable as leverage, but still material in sharing in the benefits of the SVF generated and owned by Celution.

Also the CE approval in europe for CMI will provide the additional leverage CYTX needs. If push comes to shove we know how the initial trials were undertaken and with sufficient cash we can replicate them and shut out the current data holders ......... a little bit of spine never hurt in negotiations.

I am certainly pissed off with CC handling of investors' expectations. I understand the complexity involved and hope his handling of the partnership negotiations is better. In any case, he has given me the opportunity to buy many more shares than I intended at prices below what I thought was possible. Dean, I hear yah, I double downed (NO MARGIN !!!!!)

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