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TOPIC: Clearing out and remembering

Clearing out and remembering 02 Aug 2017 02:34 #9751

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Been clearing out some old stuff last two days and remember some old posters.

Tossed a old Zacks report today...who remembers that far back when Zacks followed us ?
Deleting some links as well.
Kept my notes from last Q call just for fun as we listen to Hedrick sometime this month. Should be some extra good spin over what we have been accustomed to. Always love a good yarn :)

Some older posters we don't hear from any more
Joey Sunnyside, a rare poster here but more prolific back in the day of the YMB's and came up with the idea of the lodge. I hope he is well.
brisauto1964 used to be fun to chat with...if you still peek in here bri...hello !
d9dozrman also used to be a more regular poster that has gone quiet.
I miss WST as well...not sure he ever comes back. I wish him luck with his ATHX investment.
I am sure there are others that we had as more prolific posters that have gone silent and of course there have always been more viewers from the sidelines.
Fas, do you remember pfish from the YMB ? I think he sold out long before the lodge but used to be a good poster. He would check in at the YMB occasionally but I haven't heard from him in a very long time.
Anyway, market opens in about 6 hours. Should be another interesting day !!!
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Clearing out and remembering 02 Aug 2017 06:12 #9752

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Joe Sunnyside is Joseph Bassin from Queens in NY. If you have Facebook you can become friends. He posts more than daily.
Yes- Brian is long gone- I wish him well. I am not sure if D9 is just frustrated like we all or has sold out. I do expect he still peeks in.

Yes- I remember Fish- Marty- very well. We were in regular mail contact before he parted. I do know he invested in that Company which wanted to make organs of stem cells. They are already bankrupt for several years.

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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:

Clearing out and remembering 02 Aug 2017 09:05 #9755

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Hey Hedge, I'm still watching this disaster but there is not much to add. I thought they had a decent shot at strong results on scleroderma like others here. However, the idea that this group found a diamond in the rough in oncology and could quickly monetize it was laughable from the start based on their dismal track record. If there really was an opportunity there Azaya would have found a partner with a deeper pockets NOT Cytori, a company with huge holes in their pockets and a longstanding record of failure.

BTW, still hopeful for Athersys success and I expect a partnership this year. The table has been set, IMHO, but until its done its not done... seekingalpha.com/article/4073604-athersys-poised-lucrative-stem-cell-stroke-partnership-year

WST

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Clearing out and remembering 02 Aug 2017 09:08 #9756

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FAS

We should welcome WST back and I hope Rodney Strong (the old Chuck, Yahoo Reader, among many other names used) will be back. Of course, we should all follow your rules.

A lot of people (I think mostly small holders) are selling out and moving on.

My gut feelings (no proof, but some odd reply from Tiago) seem to indicate CYTX has not ruled out some kind of corporate strategic alliance (bigger corporate development). Maybe they should consider Celactive's previous "offer" (hinted in their website). Looks like to me Calhoun and the present CYTX Board do not see eyes to eyes.
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Clearing out and remembering 02 Aug 2017 09:36 #9757

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WST !!!!!!!!!!!!! :)

franshei
Celactive = stalking horse imho and why I responded to DOV that Fas may be right after all. No need for them to pay up even here. Hedrick got the patents away from Oxford last year. Was there always a plan "X" ?
Ca Ca Calhoun !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

Fas
If the lodge is forced to close would you be willing to keep the old newsletter with emails to keep a eye on your European friends should this really move there ?

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Clearing out and remembering 02 Aug 2017 10:08 #9759

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Hedge

It looks like there is Plan X.

I think long time ago, Hedge had mentioned that the CYTX misery may finally end when there is a "buy out of some kind". I have written Tiago on this on and off for almost 2 years. At first, Tiago indicated that: since CYTX was so close to a product marketing (in reference to the scleroderma indication), a "buy out" possibility was not considered.

Buy out does not mean the company is gone. I have seen so many biotech firms use a financial broker to allow the control of the company going to a responsible party, which will give the company financial stability and management guidance.

For the first time, I have noticed a more receptiveness in Tiago's reply.

There reason for my suggestion of Celactive is simple. Cell therapy is a very tricky business. It is very much a personalized treatment, requiring delicated physicans with know hows to treat only patients who would benefit. Often cell therapy is adjuvant to other medication. Thus, cells treatment centers, such as the Japanese OA clinics, are necessary to make the therapy successful. This is a very specialized niche market, potentially involving a lot of accredited treatment clinics.

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Clearing out and remembering 02 Aug 2017 12:03 #9760

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Hedge

Regenerative medicines work slow (very slow at times). In this culture, people have no patience for this kind of medicine. The FDA is not helpful at all, often requiring standards used for drugs for approving regenerative medicines.

This is why this kind of medicine requires a new sets of approval standards. In medical practice, individualized medical treatment is often needed.

In the case of aplastic anemia, recovery may take over a year. The illness often involves near complete destruction of the bone marrow stem cells. After initial treatment with monoclonal antibodies and then prolonged use of drugs such as cyclosporin (or in many cases bone marrow stem cells transplant), the year (often multi year long) long recovery would not return the patients back to the old normal.

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Clearing out and remembering 02 Aug 2017 14:15 #9761

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franshei
Agree, stem cell therapy is barbeque, not grilling. :)

Yes, agree on the aplastic anemia but Cytori has never been able to identify a proper segment of a patient population and until that is fixed by anyone this has little chance of big successes in treatments imho.

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Clearing out and remembering 02 Aug 2017 16:45 #9762

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Franshei,
In view of their performance to date, it's hard for me to believe that Hedrick and his staff have the expertise to develop the technology you're speaking of.

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Clearing out and remembering 02 Aug 2017 18:06 #9763

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Hedge, you say ''Cytori has never been able to identify a proper segment of a patient population and until that is fixed by anyone this has little chance of big successes in treatments imho.''

Would you say that the ''diffuse cutaneous scleroderma (DCS)'' segment is not a patient population that fulfills the criteria for
further treatment/research/success?. As a pre-defined subgroup of the phase III STAR trial do you not feel that it is possible that the FDA may see this data in a positive light (approval is something else)?. Is it not fair to say that if there is a placebo effect in the STAR trial data overall, then it should also have affected the DCS subgroup data?. If this is taken into account would it not be fair to say that the data shows a resounding positive treatment effect?

I have been financially gutted by the ineptitude of management and trial design. I dont to want any one to think that I am an apologist for management. I fear that they will not do the right thing by their shareholders * as they feel righteous and destined to bring a cure to humanity (not to mention self-serving). My fear is that even afer the dilution that is to come their ability to manage and create a vertically integrated pharma business is non existant. ADRC work, the question is whether management does?

If I am right about the efficacy in DCS then surely it is obvious to others and in particular BP and BB. Why they have not made offers is a wonder to me ............ unless of course you factor in to whom the offer is being made........ or whether reasonable offers have been declined?

My rant aside, Do you accept that the DCS data is excellent, particularly if one accepts the possibility of a placebo effect in the subgroup?

If yes, what do you think management should be doing? Not what ''will'' they do, but what should they do?. Some constructive advice/criticism would be appreciated?

*shareholders are a relative term and as such how management views them determines how they treat them. I have been a long term shareholder for over 13 years. This makes me a loyal fool. I have held on to all the shares I have bought and supported the rights offerring to holders of record. Does this entitle me to more consideraion than a day trader who flicks the shares in minutes, or the ''investment'' bank that shorts the shares it knows it is going to receive prior to placement. Obviously not.

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Clearing out and remembering 02 Aug 2017 18:39 #9764

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My rant aside, Do you accept that the DCS data is excellent, particularly if one accepts the possibility of a placebo effect in the subgroup?


How do you know the treated portion of the sub group didn't benefit by the placebo effect? The reason this was placebo controlled was to filter out the placebo effect. Can't have it both ways. Same with the OA results. Meanwhile, desperate patients are being ripped off in stem cell clinics across the U.S. and the FDA does nothing. These clinics certainly benefit from the placebo effect with Word of Mouth.

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Clearing out and remembering 02 Aug 2017 18:50 #9765

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Hi rongside
So to expand on what I was trying to say and keeping it scleroderma specific, here are some further thoughts.
We have been grabbing at one sub group to another.
First from Sclerodec 1 those that had progressed to far would not benefit but it still left lots and lots of patients. The STAR trial would weed these patients that would not benefit out. Also, surprise, the French trial showed Raynaulds had a good response. Both these groups failed stat sig in STAR. Now its DCS. Will they really benefit in a provable manner that the FDA will allow. Even Maxim seems to admit they need more to prove it. Will the right patients get picked this time or will some still mysteriously fail to respond as expected ? I do not know the answer to this but every trial that has had rigor has failed for one reason or another. This is what the company, imho, doesn't seem to be able to figure out. WHY ?
A while back Fas posted a slide that showed the cell gimish breakout from celution and I thought to myself there where some fairly wide ranges on a % basis. Pure speculation, but could this be part of the problem ? Does celution need to be better so each patient gets closer to the same mix ? Again, I don't know. I just know that each trial has failed for whatever reason.

Deals:
***unless of course you factor in to whom the offer is being made***
I believe I have speculated on this point before....maybe BP has some sort of issue.
We have heard they have turned down offers in the past as well...woohoo, talk about hindsight !

A couple years ago I thought they had 2 shots left OA and scleroderma...to me both have failed enough for me to move on...well mostly...still those few shares left. I am in a pretty good place with my decision.
I do wonder if what Fas has speculated doesn't come to pass after all.


I hope I was able to answer your questions and do hope somehow its different this time for you !!!!

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Clearing out and remembering 02 Aug 2017 21:40 #9768

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Thanks for the comments Hedge,

It is true that I have been ''been grabbing at one sub group to another''. Had this subgroup data not existed I would have to agree with you entirely. The fact of the matter is the sub-group DOES exist. I personally believe that the DCS patients show a distinct trend that differentiates it from the broader treated population. The HAQ-DI p-value at 48 weeks is SS. The data for CHFS at 5.8 is just off SS. The DCS sub-population over time shows a significant and improving difference from the total sample. THIS IS NOT RANDOM.

I await the data on the more objective clinical measurements, particularly digital ulcers. I hope that there is a substantial clinical improvement in this measure. Also please note that they did not try to heal the ulcers per se with injections/treament directly on or around the wound. A substantial improvement in this measure would go a long way in proving/supporting efficacy of ADRC in scleroderma. If this is true the systemic effect of ADRC in wounds (BARDA - burns, PAD,fistula etc) would be compelling.

I have waited a long time till now, I will wait for this additional data.

Also please note that failure to exhibit SS in Raynaulds does not mean that there was no clinical benefit, ... just that it could not be attributed to the active arm. A statement about non SS does not provide any information concerning any absolute difference beween the two groups nor any trends that may be evident over time. Again, I will wait to see how the two groups diverge over time. (assuming management provides the data).

Financial management has been truly horrendous. I am not confidant tha the company can change. At best I hope/dream of minimizing my losses.

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Clearing out and remembering 02 Aug 2017 21:55 #9769

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Hi WST,

''How do you know the treated portion of the sub group didn't benefit by the placebo effect? The reason this was placebo controlled was to filter out the placebo effect. Can't have it both ways.''

Nice piece of sophistry. Had we been looking at absolute changes in both treated subgroups and had the results been broadly the same over time then you may well have HAD a point. The data HAS diverged. A significant trend towards SS is evident. Enough said.

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Clearing out and remembering 03 Aug 2017 01:57 #9770

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rongside.... so I guess we can agree the data released is incomplete but I think given this you cannot dismiss WST's comment out of hand (sorry, no pun intended)

Here are the first 2 bullet points from the release:
1. Statistical significance not achieved in primary or secondary efficacy endpoints
2. Clinically meaningful efficacy trends observed in primary and secondary endpoints in pre-specified diffuse cutaneous scleroderma subgroup
####
My point being, why was only the subjective data released and not the objective data ?
Again they said:
"Clinically meaningful efficacy trends observed in primary and secondary endpoints"
So why didn't they show the objective stuff if they know it was a clinically meaningful trend ? I mean this would have helped understand where we really stood.
I know you too look forward to this hard data....but geez...it raises a eyebrow for me.

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Clearing out and remembering 03 Aug 2017 02:05 #9771

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For whatever it is worth- on placebo effect with injectable s.

I came across a peer reviewed scientific study a few months ago, which proved - FOR ONE ACUPUNCTURE POINT ONLY- that the healing mechanism of action for that tiny little prick was the attraction of endogeneous cells to the site of "injury".

From that I saw my long held conclusion confirmed that any injury- as Arnold Caplan also preaches- that any injury activates own MSC´s from the vascular system and brings "some" healing. A simple and plausible explanation, that we all have seen on our bodies when we cut ourselves or whatever.

Injections and what I have always called- poking with a needle in any part of the body- activates the bodies repair system and would have done so also with placebo patients in some form.

I have not had any type of pain in the past 2-3 years or so, but when I have time- I take my annual series of needle injuries- called acupuncture to enhance my health. The collective health insurance here in Germany pays for that (assuming it works against pain and nobody can prove that I do not have pain. :grin:)

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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:

Clearing out and remembering 03 Aug 2017 02:21 #9772

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Fas
Here some insurers pay for acupuncture and some don't.

Any thoughts on the lack of the objective data included in the release that I brought up in my last post on this thread ?

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Clearing out and remembering 03 Aug 2017 03:36 #9773

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Fas, your point about acupuncture and endogenous cells being attraced to point of injury is interesting and may well hold true.

I would like to provide this link concerning the placebo effect in OA which I feel also holds true for the STAR trial:

www.ncbi.nlm.nih.gov/pubmed/18541604

RESULTS:
We identified 198 trials with 193 placebo groups (16 364 patients) and 14 untreated control groups (1167 patients) that met our inclusion criteria. These included a range of therapies (non-pharmacological, pharmacological and surgical treatments). Placebo was effective at relieving pain (ES 0.51, 95% CI 0.46 to 0.55 for the placebo group and 0.03, 95% CI -0.13 to 0.18 for untreated control). Placebo was also effective at improving function and stiffness. The pain-relieving effect increased when the active treatment effect (beta=0.38, p<0.001), baseline pain (0.006, p=0.014) and sample size (0.001, p=0.004) increased, and when placebo was given through injections/needles (0.144, p=0.020).
CONCLUSION:
Placebo is effective in the treatment of OA, especially for pain, stiffness and self-reported function. The size of this effect is influenced by the strength of the active treatment, the baseline disease severity, the route of delivery and the sample size of the study.


It would appear that the more invasive the treatment the stronger the placebo effect. I find it hard to think of a more invasive treatment regimen than lipo followed by a whole bunch of injections.

Having said that, the DCS group exhibited a treament effect that overcame the placebo effect. If this can also be confirmed via more objective clinical data, then ADRC work. Whether the FDA will consider this sufficient to approve i do not know. Hopefully they will not be too anal. The DCS patients have a desperate need for this treatment. The pressure on the FDA to approve it will be substantial, assuming positive supportive clinical data, eg. digital ulcers.

Also lets not forget that in the OA trial we had good MRI data that should have some weight with the FDA and any prospective partners:

Consistent trends were observed in all six pre-specified MRI Osteoarthritis Knee Score (MOAKS) classification scores suggesting a lower degree of
target knee joint pathological worsening at 48 weeks for the treated group relative to placebo control group. The differences against placebo favored
ADRCs, some parameters achieving statistical significance, specifically in the number of bone marrow lesions, the percentage of the bone marrow
lesion that is not a cyst, the size of the bone marrow lesions as a percentage of the total sub-region volume, percentage of full thickness cartilage loss,
cartilage loss as a percentage of cartilage surface area and the size of the largest osteophyte.


Whether CYTX can push this across the line is the issue?. To not be able to partner or somehow monetize this data in a non dilutive manner would be a colossal failure. Let me repeat that COLOSSAL FAILURE.
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Clearing out and remembering 03 Aug 2017 04:29 #9775

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myownhedgefund wrote: Fas
Here some insurers pay for acupuncture and some don't.

Any thoughts on the lack of the objective data included in the release that I brought up in my last post on this thread ?


Hedge- before forming an opinion on the announcement- whether in sub-groups or as a whole, I still would like to analyse the Scleradec I paper in detail and look at the characteristics of the population treated. I have little time at present.

It is true from memory, that for instance Raynaud´s improved over time- 40-55-90 over the 1-2-3 years points.

My prelim conclusion is simply- Cytori fucked up again- too few patients i.e. under-powered and probably also too short a time frame.

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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:

Clearing out and remembering 03 Aug 2017 05:58 #9776

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Yep, they eeked out a stat sig figure on one of the two questionares at 48 weeks.
How the FDA responds will be interesting.
Potential partnerships require time and that is a luxury Cytori has to figure out.

My thoughts on what they produced with OA are well documented as well as the (so far) lack of interested parties.

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