× Predictions- positive- or negative on future happenings at Cytori.

Countdown to STAR Data

15 Jun 2017 19:24 #9470 by DOV
Several months ago, I looked up the number of days from the last patient treated in the ACT-OA trial to the press release of the data. Using the unscientific logic that it should take the same amount of time to report the STAR data, this calculation points to July 20, 2017.

With five weeks to go, one might think there would be some speculative buying in anticipation of the Phase III Pivotal Trial. In order to get FDA approval the P Values must be <.05 on the primary and secondary trial measures. We recently learned that the 24 week data would be viewed separately from the 48 week data to determine the P Values.

Cochin Hand Function Score (/92) 48.5±10.8 21.3±13.5 56% [color=]<0.0001[/color]
Raynaud’s Condition Score (/10) 7.2±0.9 0.7±1.6 90% <0.0001
Pain (VAS/10) 59.4±17.2 26.3±25.9 56% 0.0015
Scleroderma Health Assessment Questionnaire (/3) 1.36±0.3 0.83±0.6 39% 0.005
Objective Hand Function
Strength*: Pinch (kg 3.3±0.9 4.4±1.8 42% 0.05
Strength*: Grip (kg) 15.4±6.0 18.8±6.8 22% 0.012
Extension: Max. Stretch Index Finger to Thumb (mm) 110.7±24.6 123.5±26.3 12% [color=]<0.0001[/color]
Modified Rodnan Skin Score (hand) 10.92±4.85 6.25±4.88 43% [color=]<0.0001[/color]

The STAR trial was exactly the same as the Scleredec trial except STAR treated 44 patients with the Cell Therapy and had a 44 patient control group given a placebo. The Scleredec trial treated 12 patients with no control group. Two of the twelve patients had advanced scleroderma and showed no effect from the cell treatment. The remaining 10 patients all had extremely positive results after one year, even better results after two years, and even better or sustained results after three years.

In the 6th week prior to results, the stock traded between $1.00 and $1.10 ending at $1.02. Clearly the sum total of traders are betting the STAR Trial results will somehow be completely different from the exact same trial completed in France over three years ago.


Let's see what happens in the coming week.
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15 Jun 2017 22:57 - 15 Jun 2017 23:16 #9471 by franshei
WOW!

P value = or< 0.05.

US data is better than the French data.

Based on the Northwestern/Michigan studies of stem cells with and without cytoxan, the stem cells efficacy data gets better over time.

Great data.

Most of the trading comes from retail customers. Volume is relative modest.

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16 Jun 2017 05:06 - 16 Jun 2017 05:10 #9472 by fas

franshei wrote: WOW!

P value = or< 0.05.

US data is better than the French data.


Franshei-

I presume DOV posted the Scleradec I primary- and secondary endpoints, since 24 weeks data were never released.

Let´s not forget- those p data represents the statistical value for baseline to points in time- I presume these are the one year data.
From Cytori we should also get baseline to time points and values between treated and placebo. I do expect a placebo effect albeit only a small one since the patients were very informed and placebo patients are in line to get the real stuff also. That should ease their minds.

Since in Europe the patients get cryo- preserved ADRC´s and scleroderma is really a systemic disorder, which basically stems from a system autoimmune imbalance (mitochondrial damage- in my view), one could project a revival of the cryo -preservation business for Cytori, since repeat shots are most likely necessary after 3-4 years.

How does 40 Cytori cryo systems at the centres sound? I mean Green Hospital wanted to install 200 of them in Japan & other Asian countries by 2011 :bash: - chances look better for them now.:winky:

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:

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16 Jun 2017 06:37 #9473 by DOV
Yes, this data was taken from Cytori's most recent Investor Presentation. I tried to copy and paste the whole slide, but couldn't since it is a pdf.

I have been told there is a big difference between a P Value of .05 and a P Value of .001 and lower. Approval time, adoption rates, and partnership valuations are all affected.

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16 Jun 2017 07:00 #9474 by fas

DOV wrote: Yes, this data was taken from Cytori's most recent Investor Presentation. I tried to copy and paste the whole slide, but couldn't since it is a pdf.

I have been told there is a big difference between a P Value of .05 and a P Value of .001 and lower. Approval time, adoption rates, and partnership valuations are all affected.


There is a small trick to show PDF files as an image DOV. You only need to download a free "photoshop" like software like IrfanView (I have version 4.38) on your computer. Take a screenshot of your screen with the PDF page (hit Strg- left bottom and Print- right top on your keyboard at the same time)- open IrfanView and import the image- than save as jpg on your computer and upload in your post.

takes only a bit of practice.:yep:

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:

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16 Jun 2017 07:04 - 16 Jun 2017 11:00 #9475 by franshei
P = or < 0.05 is always the entry point for statistical significance in the books for the FDA. The only and only 0.05 p is for pinch strength comparison, while the grip strength is 0,015. Look at all the most important parameters: the differences between treatment and placebo are very much between night and day.

Statisitcal comparison between treatment and reference is always made from pretreatment to a specific time point posttreatment. Then, there is always comparision between certain timepoint to another to measure treatment progress.

Statisical comparison is always made within each patient to generate a group average (micro to macro).

Based on literature search, placebo effects (saline or ringer's solution) are virtually none (Hedrick has mentioned this in the last CC).

The data is perfectly FDA satisfactory - no doubts.

The pain score is much better than than the French study. Overall the US data is better and even more significant, because of a better patient selection - Dr. Khana has stressed again and again patient selection is the key to generate the desired outcome. (Maybe this is where some critics may think organ involvement is not addressed in STAR - but, in clinical development, this issue should be addressed in the next step of clinical trials, when iv dosing and liposomal incorporation is applied and maybe other drugs can be incorporated - FAS would not like this: liposomal cytoxan.)

The next question important for future revenue is treatment effectiveness,using crytopreserved stem cells. (This is not for this phase of FDA approval, but for the future application.) I think the ongoing French study can answer the question between crytofresh and crytopreserved stem cells samples, as a lead into future development in allo vs auto stem cells applications in this illness and the incorporation of an important stablization agent (liposomal excipient).

Great data, the 48 week data would be the same or even better. People who do not how the FDA works and how the clinicals are run are always think sideway. This is perfectly great data for the FDA and partnership. In my opinion, the March delay in partnership signing is because the potential partner is overly cautious - "since the 48 week data is still pending, why not wait, just in case...". I am sure CYTX has some 48 week data in March, but still the potential partner wants to wait. This is business. We clinical pharmacologists think differently.

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16 Jun 2017 11:57 #9477 by DOV
Franshei,

Just to be sure, the data I posted above was the SCLEREDEC 1 data from France. I copied it from Cytori's May, 2017 presentation at B Riley.

No data from STAR is available yet.

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16 Jun 2017 15:46 #9478 by franshei
DOV

Thanks for your clarification re the 24 month data (French).

Regarding the STAR data analysis methodologies, what do you know regarding analysing the 24 month data and the 48 month data separately? reasons or so?

This is what one would think:

At this (early) stage of data analysis (before statistical analyses between treatment groups - treatment vs placebo), one would look at pretreatment vs different stages of posttreatment. In the absence of significant placebo effects or with the difficulties of finding matching controls, pretreatment is really the reference control. Thus, efficacy and safety analyses of multi variables should be evaluated at several time intervals posttreatment and compared for trend for significance (p variation over time). P 0.05 maybe borderline at certain time, which may change + or -. Regardless how the company would do their own analyses, the FDA would redo everything based on the cleaned/finalized data base.

Partnership is always a different matter from the FDA, depending on the numbers of claims and marketing consideration. Scleordema is probably a small market and once it is approved, CYTX would probably do their own sales in the US. Realisticly, the partnership plate has to be bigger than just scleroderma. Secondary Raynaud's with shown efficacy early in the treatment (STAR study) should be an important add on for partnership talk (this may be the main reason to do a separate 24 month data analysiis to enable a new IDE filing for this indication in the second half of 2017).

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16 Jun 2017 20:04 #9479 by franshei
Yahoo Reader and others

1. Indeed, when I saw all the DOV scleroderma data under the "Countdown to STAR Data", I took it as preview information that DOV was able to get ahead of everyone else (DOV has been very resourceful before, providing us "insider" information, since he talks to CYTX senior management all the time).

Indeed, thanks to many here who have pointed out that this is 24 month French data.

2. Yet DOV's posting indicates some potential problems, such as unexplained separate treatment for 24 month and 48 month data, under the scope of P values analyses. This kind of messages may suggest that the P values for 24 months are better than 48 months.

In view of the most recent PPS weakness and unsupported suggestions that there is a possible unfavorable leak from CYTX regarding the pending 48 month data readout and the bad PPS track record, I wrote to Tiago Girao for clarification.

a. Girao insists truthfulness in his and his company's current dealings. I believe there is no leak. There could be a lot of unsupported speculations during this time with fears and exuberance in the presence of certain uncertainty.

b. The company does not have the 24 month and 48 month data yet.

c. The 48 month data readout is expected early 3rd Q. So, I think if there is no data release in July, it does not mean it is bad or good.

I rest my case and move on to other topics from here.

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17 Jun 2017 04:13 #9480 by fas
Just to help with eliminating any confusion- the data DOV showed from the Riley Presentation were the THREE years SCLERADEC I data- nothing with weeks- 3 years even and were as shown below:


Just a speculation from my side- obviously the folks at Callan Road are sifting through all the data as we speak and nothing is published- still they already did the MYTOMORROWS deal and my Dutch countrymen did not have to wait for another few weeks to see the final numbers.

Shows faith and confidence I would say. :grin:

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:
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17 Jun 2017 07:58 #9481 by DOV
From the 1st quarter conference call transcript:

HEDRICK:
"In June 2016, we randomize the 88th patient in the U.S. STAR trial for scleroderma the hand. STAR is a randomized double-blind placebo-controlled trial with a cross over arm to treatment for placebo recipients after 48 weeks. The primary study endpoint for the trial is a Cochin Hand Function Score measured at 24 and 48 weeks after treatment.

We have agreement on the statistical analysis plan with the FDA. In one note about that plan, is that the Hockberg procedure will be used as a multiplicity adjustment when reviewing the results from the ANCOVA for the Cochin score at 24 and 48 weeks. (potential spelling errors)

This approach may enable us to obtain approval on potentially either the 24 or 48-week time point without related alpha spent. The key secondary endpoints are Raynaud's condition score at 48 weeks and the scleroderma health assessment questionnaire or the SHAQ at 48 weeks. There are number of other exploratory endpoints that we are also assessing as part of this trial.

In terms of the timeline, the full 48-week data lock statistical analysis and readout in STAR is on track and expected by early Q3 2017. The regulatory path in the U.S. for this product will be as a PMA premarket approval as a Class III device. One note I'd like to make as we been asked a number of times about various alternative regulatory pathways for this product. A regulatory path we think potentially may be available to us for Habeo is the FDA's new expedited access program or EAP."

This is all I know about separating the 24 week and the 48 week data. I have never discussed this with anyone at the company. If I understand Hedrick's comment correctly, this increases our chances for approval. However, since the SCLEREDEC 1 data was very strong at all time periods, to me it is probably meaningless. The video that was shown at the Investor Day at Maxim's offices last December was an interview with 5 women from SCLEREDEC 1. They all stated that significant improvement was noticed in the first few weeks.

A note about the new expedited access program or EAP: this pathway would be selected by Cytori if the P Values in the STAR Trial are marginal. If the P Values are as robust as SCLEREDEC 1, Cytori will press for early PMA approval. They will solicit the lobbying help of the Scleroderma Foundation and several of the KOLs that are vocal advocates of this procedure. If the Raynauds data is also robust, Cytori will ask the FDA for on label approval for that indication as well. This is more of a "why not ask" scenario and Cytori does not believe the FDA will include Raynauds in the approval. The FDA is known for excessive proof and for driving up the cost of drug development even when there are no side effects.

One other thing of interest. Not only was there a video played of the 5 women from SCLEREDEC 1, but there was a doctor (KOL) that brought a scleroderma patient to the Investor Day. Cytori thought the doctor was bringing a random patient to demonstrate the debilitating disease. They were very surprised that the patient had been treated in the STAR Trial. It was unknown if this patient was treated or in the placebo group, but her message was that she felt much better. There is too much anecdotal evidence for me to be very worried about the STAR results. Having said that, I was not at Investor Day at Maxim. There were many who were and they could only do a secondary at $1.10 when the stock closed at $1.72. During the 6th week prior to STAR data, we saw a very strong resistance point at $1.10 indicating many of the buyers of the secondary want out at a break-even number. So the investment bankers who had the privilege of seeing the video and meet a STAR patient are not excited enough about the coming Phase III data to buy the stock ahead of the results, at least not six weeks out. We are now in the 5th week out and the stock broke below the $1.00 barrier.

I do not believe there have been any leaks from the CRO or Cytori. Calhoun is long gone!

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17 Jun 2017 15:23 - 17 Jun 2017 18:09 #9482 by franshei
DOV and FAS, Many thanks for many well conceived thoughts.

I am breaking my own previous note to leave this topic re STAR data speculation. I think many people here and there (YH) have many thoughts on this topic and many are very worrying, because of the stock price.

I hope my thoughts would represent middle of the road and I hope this path is not a vision of light of an oncoming train in the middle of the night.

It is very hard to image that the STAR 48 month data would be completely off track from the French study. (Maybe it is off track, because in a larger patient population from the initial 12 patients, the power of difference between treatment and control could be down - "stem cells therapy is always considered a marginal therapy", as many people would have said all the time.)

It is likely, I believe, the STAR data is adequate for FDA registration (here and EU), but for various reasons (such as market size and other concerns that WST has raised before) the company will not be able to find a corporate partner, willing to pay a big upfront money (so many people are thinking this would resolve all the CYTX financial woes and lift the PPS). CYTX , I believe based on all the presentation slides particularly the latest one, is telling us new money may come from ATM, Lincoln Park, partnership from lipo doxo, small partnerships (if any).... but not really from the stem cells therapy. John Harris was interviewed by Xconomy (spelling?) and his message is clear: stem cells will probably remain small relative to nanotech.

I think CYTX will do US scleroderma sales and marketing solo (primarily 40 specialized treatment centers) and myTomorrows will do the MAP, till there is a company coming in to do real sales and marketing.

I think CYTX is actively preparing a IDE filing for the secondary Raynaud's and the STAR 24 month data is part of the pending submission. (Note: PMA filing using the 48 month data is a different filing and complete stats would take a much longer time to complete. PMA documentation is much, much bigger than an IDE filing. A complete PMA submission could easily take up to 125 volumes and data tapes.)

I think the STAR 48 month data readout will be a positive corporate event, but it will not be such an event to propel the stock price to $ 5 overnight. The stock may go up and down as before (till lipo doxo partnership is in), This is only the beginning for more r/d activities: secondary Raynaud's (bigger market size than scleroderma), CXT2 market launch, lipo doxo manufacturing plant validation( and trial runs), stability testing, etc, leading to EU ANDA submission. See Hedrick's latest 2017 corporate miles tones.

If there is any corporate partnership with upfront money, it will probably come from lipo doxo and not from the stem cells.

Fear has probably gripped a lot of people betting big on a big runup in PPS (and stay up) upon the release of the STAR data readout.

Finally, some feedback in reference to DOV's last paragraph.

Ever since Hedrick and Girao have in charge of the company, we have gone through many, many stock price drops, all relating to the need of corporate financing. All along, the company (Hedrick and Girao) has expressed confidence in their works and successes. Yet, the Street has not paid attention to this confidence, as long as there is a need for new corporate financing. Hedrick and Girao have been held hostage.

Based on all my recent correspondence with Girao, the company is confident as before in their plan, works and achievements. I think the current stock price weakness may not have to do with what they are doing and what the STAR 48 month data readout maybe. The Street, as D'Silva has written (TP to around $ 2.5 from over $ 6)and the recent SEC filings have indicated, knows more money is needed to fuel the fast running engine (new corporate headquarters, new r/d in San Antonio, etc), if there is no scleroderma partnership (which is considered unlikely, because of its small market size) or partnership of any kind.

I still believe the pending STAR data readout will be positive, not off track from the French study (as the company may have tried to bring out in the cited Maxim investors meeting) and the current stock price drop has nothing to do with this.

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18 Jun 2017 04:33 - 18 Jun 2017 06:40 #9483 by fas

DOV wrote: . If the Raynauds data is also robust, Cytori will ask the FDA for on label approval for that indication as well. This is more of a "why not ask" scenario and Cytori does not believe the FDA will include Raynauds in the approval. The FDA is known for excessive proof and for driving up the cost of drug development even when there are no side effects.


Since I have been busy with my own health more the past 2-3 years, I must say the extremely strong results in Raynaud´s eluded me, which I must admit to my embarrassment. A 90% improvement after 3 years in SCLERADEC I, is virtually a cure and even a 70-80% improvement after 1 year would come very close.

If we look again at what it is- this is from the Mayo clinic-

Raynaud's (ray-NOHZ) disease causes some areas of your body — such as your fingers and toes — to feel numb and cold in response to cold temperatures or stress. In Raynaud's disease, smaller arteries that supply blood to your skin narrow, limiting blood circulation to affected areas (vasospasm).

Women are more likely than men to have Raynaud's disease, also known as Raynaud or Raynaud's phenomenon or syndrome. It appears to be more common in people who live in colder climates.

Treatment of Raynaud's disease depends on its severity and whether you have other health conditions. For most people, Raynaud's disease isn't disabling, but can affect quality of life


Here I conclude that a "separate name is given for a blood circulation issue", which has its roots in Insulin Resistance (IR), followed by autoimmune/inflammation issues and resulting atherosclerosis. ADRCs apparently do extremely well in confined area´s with limited blood flow (hypoxia), which I already concluded in the Odds and Ends topic.

Of course there are folks with more full-blown IR, than conventional medicine diagnoses on high fasting blood glucose levels- although the ROOT CAUSE is hyperinsulinemia (high insulin fasting blood levels)- that the patient has Type 2 diabetes.

OTHER EXTREMITIES- lower leg and feet
So- the same treatment, which we already saw proven in the Naples study, can vastly improve blood flow and- as a result- developed diabetic ulcers- in the leg. Of course- after Raynaud´s - this will be THE homerun indication for already proven technology.

Hands or feet- in all confined areas of the body with blood flow issues, ADRCs work well.

I think with the Naples study in hand and knowledge of STAR, it will not be difficult to find takers i.e. partners.

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:
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18 Jun 2017 06:46 #9485 by fas

fas wrote:
OTHER EXTREMITIES- lower leg and feet
So- the same treatment, which we already saw proven in the Naples study, can vastly improve blood flow and- as a result- developed diabetic ulcers- in the leg. Of course- after Raynaud´s - this will be THE homerun indication for already proven technology.

Hands or feet- in all confined areas of the body with blood flow issues, ADRCs work well.

I think with the Naples study in hand and knowledge of STAR, it will not be difficult to find takers i.e. partners.


Just to prove that I am not the only one with this idea (and knowledge). At Marseille already a 45 patient study is ready for take- off as open label study. My bet is, that they are waiting for STAR results to possibly convert that study into a pivotal study- i.e. randomized and double blinded.

Diabetic foot ulcer (DFU) is a major complication and the leading cause of hospitalization among people with diabetes mellitus. It occurs in 15% of all patients with diabetes and precedes 84% of all lower leg amputations. Despite many therapeutic advances over the past decades, including dressings (hydrocolloids, alginate, skin substitutes) and growth factors, healing rates of DFU remain low.

Mechanisms of faulty wound healing in diabetic patients are complex, related to both intrinsic and extrinsic factors. The main reasons for impaired healing appears to be: 1/exhaustion of local cell populations that promote wound healing; 2/excessive production of matrix metalloproteases (MMPs) coupled with reduced expression of the tissue inhibitors of MMPs; 3/impaired neovascularisation coupled with reduced numbers of endothelial progenitor cells and impairment of their functioning. These imbalances may result in excessive degradation of extracellular matrix components, as well as an inappropriate local inflammatory response .

Adipose-derived stroma vascular fraction provides a rich and easily accessible source of autologous cells for regenerative medicine applications. Il contains multipotent stem cells and progenitors called adipose-derived regenerative cells (ADRCs) able to stimulate wound healing. There are attracted to the wound site where they supplement the wound bed with similar cell types, secrete numerous growth factors and cytokines, increase macrophage recruitment, enhance granulation tissue, and improve vascularisation . The reparative capabilities coupled with good safety of ADRCs have been illustrated in a study for treating severe and irreversible radiation-induced lesions, and in a study for treating sclerodactyly in patients with diffuse scleroderma. Numerous case reports showing healing of refractory wounds following treatment with autologous ADRCs have also been reported.

Based on these previous reports, the present study aims to assess the efficacy and tolerance of injection of ADRCs for the local treatment of neuropathic or neuro-ischemic DFU.



Link- HERE

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:
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20 Jun 2017 08:55 #9488 by fas
DOV wrote in the opening post of this thread:

Several months ago, I looked up the number of days from the last patient treated in the ACT-OA trial to the press release of the data. Using the unscientific logic that it should take the same amount of time to report the STAR data, this calculation points to July 20, 2017.


Since we are all waiting for this binary event and surely members with bigger investments in Cytori have their nerves pretty much stressed, I thought I would propose a little "passing-the-time" game in guessing the actual date of the release of the STAR data. The winner will receive an honorary membership of the Raccoon Lodge and the accompanying official document signed by myself in recognition of such honourable feat.

Of course I may compete myself too and my pick is June 29.

Reasons for that particular selection are the following:

1. We do not know when the last ACT-OA patient showed up for his last appointment to "close the book" on the study. I think the STAR patients were more dedicated.
2. Cytori did not have much incentive to report the ACT-OA data, since they obviously selected a pretty lousy primary endpoint with high risk for a substantial placebo effect.
3. With STAR the opposite is true and since the general market is pretty sturdy at present, ASAP would be a good choice.
4. ACT-OA had heaps of MRI data on the building of cartilage etc, this would be a lot more labour intensive to check out compared to the straight forward STAR deliverables.

Therefore my selection- soon - specifically JUNE 29.

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:

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20 Jun 2017 09:54 #9489 by belgiumineurope
I say July 21....the Belgian National Day !!

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20 Jun 2017 11:13 #9490 by DOV
Fas, I am sure you have a copy of the 1st quarter earnings conference call transcript. Near the very end, Hedrick answered a write-in question about the timing of the STAR data release. Hedrick did say it was possible the data could be available late in the 2nd quarter although he was sticking with his prediction of early Q3.

Your estimate has merit and would shorten the time available to the short interest crowd to cover ahead of the data. There is a big bet over how to fund the company starting in September when the cash position once again falls below loan covenants of $5 million. If a partnership was delayed, as we have been led to believe, waiting for data to pay that much upfront, then there will not be another "significant" dilution assuming data equals Scleredec 1.

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20 Jun 2017 12:26 #9491 by irrationalexuberance
My call is Monday July 10th, premarket.

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21 Jun 2017 09:40 - 21 Jun 2017 09:43 #9492 by b767cpt
June 29? Interesting Fas, I would like too see it prior to July also but one would believe that we should see some price action increase by now for that time frame.
I'll go with a Thursday July 13. I might add that if I win, I'll hold you to that signed document to frame and hang on my office wall.

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21 Jun 2017 10:28 - 21 Jun 2017 10:29 #9493 by fas

b767cpt wrote: June 29? Interesting Fas, I would like too see it prior to July also but one would believe that we should see some price action increase by now for that time frame.
I'll go with a Thursday July 13. I might add that if I win, I'll hold you to that signed document to frame and hang on my office wall.


I also think Cytori - like DOV- is pretty much a "closed shop" nowadays.

From DOV´s post: I do not believe there have been any leaks from the CRO or Cytori. Calhoun is long gone!

The one event that could be interpreted in another fashion was the BARDA FDA news, where the stock went over 2$ which triggered the secondary and resulted in Sabby et al in doing big time front running. That was different, contractual arrangement and not "information leaks". Still horrifying of course and another lousy management decision on the backs of shareholders.

I do not expect any price action before the announcement- there is no trust or confidence in Cytori and its management period- only in the tech by folks like DOV and myself.

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:

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