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TOPIC: Lousy Announcement on OA-More data needed

Lousy Announcement on OA-More data needed 10 Feb 2016 09:17 #6271

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Being back from being away, one really gets unnecessary shocks sometimes when Cytori is involved in the news. When I opened my tablet on Tuesday morning to read what´s up in the Lodge, I simply closed it 5 minutes later, since I did not believe what was written. :bash:

Having calmed down by now- it is clear to me- Cytori i.e. Hedrick shot himself one in the leg ..again.. by publishing the results of OA without any meaningful data from which an investor could get a grasp of what is going on.

The two words of "significance" where accompanied by nothing from which the reader could deduce what "significant" was..

Zero points for Cytori management. :evil: :evil:

Anyway- WE NEED MORE DATA- first chance comes right away at the Convene in New York. :whistle:

Hopefully he takes it :evil: :evil:

The announcement- since I missed that one yesterday very much.. :winky:

02/08/2016
Data suggest beneficial effect of ECCO-50 for knee osteoarthritis: full data set expected Q3 2016
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today the top-line data as part of the pre-specified partial unblinding of 24 week follow up data from the company’s ACT-OA trial. The trial is a U.S. phase II randomized, double-blind, placebo controlled trial designed to evaluate the safety and feasibility at 48 weeks of a single intra-articular knee injection of the ECCO-50 cellular therapeutic in patients with chronic knee pain due to osteoarthritis.
“Key endpoints and trends observed thus far suggest that a beneficial effect may be attributable to a single intra-articular administration of ECCO-50 in patients with osteoarthritis of the knee,” said Dr. Marc H. Hedrick, President and CEO of Cytori Therapeutics. “The full 48 week data set is the next important milestone in this program. While we continue to move our clinical pipeline along, the company will remain intensely focused on bringing to market our lead therapeutic for scleroderma which is currently in phase III.”
The primary goal of the ACT-OA trial is to help determine: (1) safety and feasibility of ECCO-50 for osteoarthritis, (2) provide dosing guidance and (3) explore key trial endpoints useful for a phase III trial. As a proof of concept trial, ACT-OA was not sized or powered for statistical significance in any of the endpoints.
The purpose of the interim 24 week partial unblinding in this trial is to provide early data that will facilitate key regulatory and business development discussions and provide better understanding of the therapeutic mechanism of action that may impact other clinical programs.
The interim analysis pre-specifies the evaluation of a number of patient reported outcomes important in patients with osteoarthritis of the knee. A total of 94 patients were treated in the trial (30 received a low dose of ECCO-50 [20 million cells], 31 received a high dose of ECCO-50 [40 million cells] and 33 received placebo). Patients, providers and Cytori personnel remain blinded to individual patient treatment allocation and patient subgroup outcomes.
The interim top-line data show the following:
1.Intra-articular application of a single dose of ECCO-50 appears to be safe and feasible in an outpatient day-surgery setting. No complications occurred related to the fat harvest, cell processing or cell delivery.
2. A significant placebo response was observed, similar to that demonstrated in other OA trials.
3. The pre-specified primary endpoint, pain on walking at 12 weeks, as measured by a single question from the Knee Injury and Osteoarthritis Outcome Score (KOOS) did not obtain statistical significance.
4. Key secondary endpoints include the total and sub-scores of the KOOS, patient assessment of knee pain, knee stability, osteoarthritis activity and osteoarthritis damage, use of as-needed pain medication, pain while walking 50 feet and health status as measured by the SF-36. Consistent trends were observed suggesting improvement in the cell treated group relative to the placebo group at the 12 and 24 week time periods for patient reported outcomes.
5. Both high dose and low dose of ECCO-50 performed similarly.
In the 3rd quarter, following full unblinding of the data, the Company will be able to more fully evaluate the data, including 48 week follow up, patient subset analyses, and the effect on knee cartilage as measured by magnetic resonance imaging results changes between baseline and 48 weeks.
In summary, patterns of response are suggestive of a beneficial effect attributable to a single intra-articular administration of ECCO-50 in patients with osteoarthritis of the knee. The full 48 week data are expected to be available for review during the third quarter of this year, which will more fully inform further development decisions, including phase III trial design, cell dose, administration protocol, inclusion/exclusion criteria, selection of primary and secondary endpoints and sample size. Further details of the trial can be found on clinicaltrials.gov (NCT02326961).

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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:

Lousy Announcement on OA-More data needed 10 Feb 2016 09:39 #6272

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finance.yahoo.com/news/cytori-tanks-unfavorable-data-osteoarthritis-214509513.html

This was the response to Cytori announcement on OA data. I think Zack article expresses how most of us interpreted the release. I believe that management views the data release differently bu there message did not get through. In the future I hope that they use a professional IR/PR firm to script all future announcements. The street has a negative opinion on Cytori and rightfully so. It is critical that messaging improves. I think an immediate clarification is in order to correct the message. Not just in a presentation that few will listen to or see put in the public eye like the Zack comment.

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Lousy Announcement on OA-More data needed 10 Feb 2016 10:01 #6274

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I see this slide in the presentation in progress right now-




This indicates a 50% placebo effect- if one assumes the KOOS pain thing is part of that, that means the placebo effect is not just significant- it was gigantic- patients- all patients must have strongly believed in it.

Anyway- the treated group was even better- but with a number of 50% I do not know what is required to make it significant. .

These results must have been extremely good- contrary to the market reaction. :cool:
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Lousy Announcement on OA-More data needed 10 Feb 2016 10:07 #6275

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Fas,

Don't you think if they had good interim data they would provide all the details and trumpet them all the way to a partnership? It is clear that while ADRC group may have improved so did the placebo group. There was also no dose related response so far. Does the data improve at 48 weeks? Maybe, but you can't get water from a stone with the interim data. Marc did just say on the call that the "positive OA data" should be good enough to extend the debt amortization.

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Lousy Announcement on OA-More data needed 10 Feb 2016 10:13 #6276

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At the end of the presentation-

Hedrick expects Cytori to be profitable by 2018 (or so- he said.. :vegas: )

back to the drawing boards- Hedge and DOV, actually I might give it go myself for a change.. :whistle:

At the very very end, he reminded of the peripheral vascular disease clinic in Japan..wow - but they do not have data yet, he said.. :whistle:

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Lousy Announcement on OA-More data needed 10 Feb 2016 10:27 #6277

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Wall Street Titan wrote: Fas,

Don't you think if they had good interim data they would provide all the details and trumpet them all the way to a partnership? It is clear that while ADRC group may have improved so did the placebo group. There was also no dose related response so far. Does the data improve at 48 weeks? Maybe, but you can't get water from a stone with the interim data. Marc did just say on the call that the "positive OA data" should be good enough to extend the debt amortization.


WST-

You would think they would try to make the announcement as positive as possible yes- any sensible BUSINESS MAN would- Hedrick is a very conservative doctor though...and this confirms (AGAIN) what others have told about him... :really:

which makes the 2018 profitability statement pretty astonishing really :whistle:

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Lousy Announcement on OA-More data needed 10 Feb 2016 10:35 #6278

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yes- any sensible BUSINESS MAN would- Hedrick is a very conservative doctor though


He may be conservative in making projections but we are talking about data, not the future. I think, like any reasonable CEO in this situation he has put the best spin possible and more details are very unlikely to help. If there is a partnership announcement, in the next few months, it will likely come from scleroderma.

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Lousy Announcement on OA-More data needed 10 Feb 2016 10:56 #6279

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Fas wrote:

You would think they would try to make the announcement as positive as possible yes- any sensible BUSINESS MAN would


Fas,

I recently re-read your conspiracy theory. Do you still hold this opinion? This announcement certainly could be seen as further evidence of your argument.

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Lousy Announcement on OA-More data needed 10 Feb 2016 11:30 #6280

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Maxim Report
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Lousy Announcement on OA-More data needed 10 Feb 2016 11:34 #6281

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Welcome back Fas !

The biggest take away for me was no partnership coming from the data in the annoumcement (imho) and where does the funding come from. R/S now front and center with a even bigger multiple than hoped for likely.
If they do the R/S Or is Celactive now front and center for a license deal? EU scleroderma partner ? I think the idis deal showed that has been pushed off but hard to say for sure. Market seems to think its the R/S and then tapping then ATM.

Amazingly another trial blunder.

Look forward to you thoughts on the future earnings. We have heard the profitability word before. No one will put stock into until it comes. These guys have cried wolf too many times !!!!!!!!!!!!!!!!!!!!!!

DOV may be on the road with work. No response here at the lodge. Have you had any contact with him Fas ?
He also may still be in shock....weak verbiage was the one thing he didn't want to see in the OA press release.

All in all...par for the course for Cytori :bang: :bash:

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Lousy Announcement on OA-More data needed 10 Feb 2016 11:39 #6282

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rothco

JK really wants to be part of the next funding.

R/S and Maxim ? :puke: :whistle: :cry:

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Lousy Announcement on OA-More data needed 10 Feb 2016 11:47 #6283

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Wall Street Titan wrote:

yes- any sensible BUSINESS MAN would- Hedrick is a very conservative doctor though


He may be conservative in making projections but we are talking about data, not the future. I think, like any reasonable CEO in this situation he has put the best spin possible and more details are very unlikely to help. If there is a partnership announcement, in the next few months, it will likely come from scleroderma.


The slide did say-

Strong Placebo response approx. 50% in certain measurements

my assumption is that this is for the pain score.. :whistle: and the 50% was nowhere indicated in the announcement, meaning they definitely could have done better- in my view :evil:

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Lousy Announcement on OA-More data needed 10 Feb 2016 12:18 #6284

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Yes JK does want to stay in the mix for funding for sure. Based on conversation with Marc and Tiago, I would surmise that unless Celactive comes to the table with serious cash and organization Cytori will not make that kind of deal or even another Lorem vascular deal. As to LV they need to keep up with there obligations for 2016 in order to maintain licensing agreements. Cellution equiptment orders will need to be paid for cash in hand, to avoid any default payment. Cytori will not take that chance. I do not like the idea of RS at these levels. I also believe that with the artificial increase in PPS that an RS would bring that the shorts would just have reason to attack again. I don't care about the listing, get an extension and if profitability is to come in 2018 there will have to be something meaningful happening between now and then. Enough dilution.

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Lousy Announcement on OA-More data needed 10 Feb 2016 12:51 #6286

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You cannot stop a skinning ship. Lifeboat belongs to Chris (I have a feeling Marc knew that already), and the offer will be Awful. Shareholders should get screwed BIG time, but Chris is the last hope now.

OR a massive RS (My original 50 or 100 estimates stands), to turn it into a very YOUNG start up again.. some lipstick and try again over there :puke:

That reminds me, maybe the price of oil is making Chris think twice before finishing the deal.

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Lousy Announcement on OA-More data needed 10 Feb 2016 12:55 #6287

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fatboy wrote: Fas wrote:

You would think they would try to make the announcement as positive as possible yes- any sensible BUSINESS MAN would


Fas,

I recently re-read your conspiracy theory. Do you still hold this opinion? This announcement certainly could be seen as further evidence of your argument.


Fatboy-

I called it my worst scenario. It obviously still is my worst scenario, which in a minimax model I would give a weighting of 15-20% or so... :whistle:

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Lousy Announcement on OA-More data needed 10 Feb 2016 12:59 #6289

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rothco

So you sound like you are still hopeful for a OA or EU scleroderma deal.
Am I reading you wrong ?

I guess we have also left out a potential Japanese partner. LOL, oh boy ! :grin: :bash:

W/O a R/S your talking a astronomical # of shares that would need to be issued.
I agree on the shorts with a R/S ...that is why it would need to be large enough that they could not quickly push it sub $1 again.

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Lousy Announcement on OA-More data needed 10 Feb 2016 13:01 #6290

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myownhedgefund wrote: rothco


W/O a R/S your talking a astronomical # of shares that would need to be issued.
I agree on the shorts with a R/S ...that is why it would need to be large enough that they could not quickly push it sub $1 again.


You mean my original 50-100 RS that you called crazy?

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Lousy Announcement on OA-More data needed 10 Feb 2016 13:08 #6291

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sorry cytxer...your still too high imho

Time is short so we will know in a number of months but my dream come true of a 1:10 is certainly out the window.

:cry:

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Lousy Announcement on OA-More data needed 10 Feb 2016 13:22 #6292

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yes fas,

the anouncement is missleading. Only relative to placebo. What are the absolut data with cells for pain? As is know the data from the czech study was that 9 from 10 has an improvement of more than 50%. I dont think that cytory recieve not equal data.

Scheiß job.

holdi

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holdi

Lousy Announcement on OA-More data needed 10 Feb 2016 14:08 #6294

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Old Young Fox wrote: yes fas,

the anouncement is missleading. Only relative to placebo. What are the absolut data with cells for pain? As is know the data from the czech study was that 9 from 10 has an improvement of more than 50%. I dont think that cytory recieve not equal data.

Scheiß job.

holdi


Holdi-

Sounds crazy, but one could even make an argument that they made this "shit job announcement" on PURPOSE!!!!!!!

If a clinic is NOT powered for statistical significance, WHY THE HELL does one make this statement ???????????????????????????

3. The pre-specified primary endpoint, pain on walking at 12 weeks, as measured by a single question from the Knee Injury and Osteoarthritis Outcome Score (KOOS) did not obtain statistical significance.


The nill hypothesis always assumes a placebo effect of zero, so statistical significance can not be achieved with a large placebo effect anyway in my view.
[/b]
Fatboy- I just increased the likelihood of my worst case scenario with 5% in my minimax model. :puke:

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