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Question for Callan Road 01 Dec 2016 18:36 #8126

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Quite some time ago I asked the question : Why aren't they focusing on Scleroderma? At the time I believed it to be low hanging fruit. Eventually they did. I am not so naive as to believe that they did it because I asked the question. However, in retrospect it is the indication that may save the company (the shareholders is a different issue).

I pose the same question now. Why aren't they focusing on anal fistula (or fistula in general)? We have seen a myriad of independent trials undertaken by investigators/surgeons in a variety of different countries with successful outcomes. This provides a high degree of confidence that the results are not random. If they cannot fund it themselves then surely it can be partnered? Have other sources of funding such as CIRM and NIH etc. not been approached. I find it inconceivable not to mention UNCONSCIONABLE that there is not a registration quality trial near completion in this indication.

All the BARDA research to date is a major reinforcing factor in boosting confidence that such a trial would be successful. In fact it should automatically be a high powered phase II trial.

I can understand the difficulty in dealing with a regulatory body that has to face a new paradigm........ ie. a "drug" that is manufactured at the bedside and is unique to the individual. It is what it is. The FDA is mandated to approve safe effective treatments, not to pontificate on the merits of approving a new treatment methodology because it is different.
Scleroderma works and the FDA will have to deal with it. Everything changes with the 1st approval.

I cannot believe that $20M cannot be found to cross the scleroderma finish line without having the existing shareholders raped. I appreciate that we may be a small group who have been diluted to buggery and that in the great scheme of things this is not managements problem. However they gave us a chance to fund the company directly after heavy dilution and we did so. Time to succeed so that capital can be raised by true believers and risk takers .......... not front running arbitrageurs. Hedrick aren't you pisssed off: I am.

By the way, here is the basis for my rant :

onlinelibrary.wiley.com/doi/10.1111/codi.13555/abstract

Symptom duration was 24 months. Cure was in +/- one month. NO BRAINER !!!!!!!!!!!!!!!!!!!!!!!!!!

Anyone want to guess what the cost benefit analysis of the 24 months of pain to one month for cure.

Just saying, I am at a bit of a loose end right now. Would Cytori like me to ring a few numbers for them?

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Question for Callan Road 01 Dec 2016 18:48 #8127

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Sorry for my haste. Fissures and fistula are not the same thing. However a fissure that has been causing pain for 24 months and cannot be healed is no minor thing. It requires surgery under general anesthesia.
The ADRC/Celution treatment results were very impressive. Complete pain cessation in one month - complete healing within three months.

As for my other comments, I stand by them.
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Question for Callan Road 02 Dec 2016 08:39 #8130

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Rodney Strong

1. It looks like you are talking to Tiago Girao at Callan Road. He is a nice guy and a good book keeper. He also works night and day for Hedrick. While he does not carry much weight, you should ask him and others at Callan to read FAS message board.

2. Another topic: This stock has probably been "hacked". Everybody elsewhere always think Chinese and Russians are good in cyber attacks. Why not here and our government and the company are powerless to do something about this situation.

Talking about Chinese, let us talk about Lorem and BoyaLife.

Lorem has not met the licensing obligations and everyone here and at Callan are mad with them. They were also behind the sharp drop in our PPS at certain time in the past.

But, CYTX may not have to withdraw the licensing agreement entirely. They should allow Harris to work with them at their expenses.

BoyaLife - an emerging Chinese stem cells r/d holding company (funded by the Chinese government) which practically owns KOOL. KOOL's PPS goes up and down sharply every day and it looks like someone is behind the manipulation (Chinese?). In my opinion, BoyaLife is aggressively acquiring
US stem cells companies quietly and they may want to get a piece of CYTX cheap (by manipulation?). The problem for BoyaLIfe's interests in CYTX is probably BARDA - it is a US military project. They may want to bid for the scleroderma indication, but they may be cheap (just like Lorem).

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Question for Callan Road 02 Dec 2016 09:49 #8131

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Franshei-

The people of Cytori know this board- San Diego is always top of the list of visitors by city- than again, I do not think Hedrick reads here. He surely wants to keep his mental sanity :grin:

Anyway, John- anything which is closely related to wound healing simply works great- I agree, it should not be difficult to pick up 20 Mio from somebody, especially if they already had "a generous offer" for US scleroderma. I am as pissed as you, that nothing happened so far, since Hedrick should know what Wallstreet does when the bottom of the coffer is less than 6 months away....

Lets hope everything will be different than the past 10 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:

Question for Callan Road 02 Dec 2016 10:05 #8132

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This company has pissed away close to 300 million dollars in shareholder's money. This has been and continues to be a scam. I have not used that word in the past but it is indisputable. The actions by the management team I believe is actually criminal. Fortunately for this band of thieves they are protected by the corporate veil. I find it hard to believe that a few of you still hold out hope that these guys actually give a shit about shareholders. Lorem is a fraud , and Cytori is doing nothing about there breaches because they have nowhere else to turn. Why bother to call Mark or Tiago all your going to get is lies. As suckers are born every minute as we are all proof of that, they will try to get as much of other people's money as they can before they file for bankruptcy and the company will be awarded to off shore holders to ultimately profit fro technology. This is all legal, and hopefully this will change under Trump. Who better then one who has used the loopholes to full advantage to close them.

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Question for Callan Road 02 Dec 2016 14:23 #8133

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Rothco,

Your post put a real damper on what appeared to be a developing increase in posting activity early in the day - can't understand why since it was so uplifting going into weekend - lol - but I do feel your pain literally as do many others - it has been a tough road to haul with all the disappointments over the years, and the current absurd SP :bash: :bash: :bash:

PS - don't be too harsh on Lim - if you were him, you might not be so cooperative either after having bought 8 million shares at $3 pre-split not too many years ago. :KO: :KO: :KO:

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Question for Callan Road 02 Dec 2016 14:46 #8134

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rothco619 wrote: This company has pissed away close to 300 million dollars in shareholder's money.


Just to put the record straight- as of September 30, 2016- the accumulated deficit of Cytori is 374,144,000 US$ so slightly more than your 300 Mio, but still with the market cap of 31 Mio.

Something is not kosher here, considering my knowledge of the technology and I do not trust Hedrick for one penny either. :really:

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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:

Question for Callan Road 02 Dec 2016 15:24 #8135

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Very sad to spend 374 million and wind-up with only 30 million of value - of course, the 30 million is just not real and reflects big-time manipulation (BARDA alone is worth way more than 30 million) - nevertheless, there is no question that the boys at CYTX pissed-away a lot of money of which a lot went into their own pockets.

PS - Fas, have you heard from Hedgefund - not like him not to post for such a long period particularly on subjects that are right up his alley.

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Question for Callan Road 02 Dec 2016 15:45 #8136

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I disagree with those who suspect fraud. I see the failure as a series of mishaps that started with the failure to obtain a favorable 510k ruling. In retrospect, once they couldn't get this device approval path, the writing was pretty much on the wall. They were foolish to spend so much time and resources suing the FDA. It is clear in retrospect, that without the 510K approval the autologous model was a real long shot. Then they wasted resources on the souped up Celution One that went nowhere when they should have been going smaller and cheaper for breast reconstruction in the EU. Tigenix, another fat term cell company made the change to allogeneic and they obtained a nice partnership deal based on Phase III Fistula data. Capricor also saw the huge hurdles with autologous and switched over to allogeneic and they also got partnership money and CIRM funding for their heart cell therapy (among others). Athersys has scored three major partnerships with upfront cash - again allogeneic. Cytori may have been able to overcome this problem if they scored on OA. I was very surprised that they failed in the Phase II and I gave a few potential reasons (in adequate dosing, need for a biological matrix, randomness of donor cell viability, etc.). In retrospect, KT Lim was stupid for partnering with Cytori but Cytori was smart in taking his money - BECAUSE NO LEGITIMATE COMPANY CAME TO THE TABLE - again the autologous model was the main culprit. So this is NOT ABOUT FRAUD, IMHO. It's more about a series of poor decisions and a flawed business model from the outset. Management WAS guilty of overpaying themselves and overstaffing. Remember Clyde Shores and all the other overpaid execs that came and went? To think of how much money these guys made over the years for accomplishing close to NOTHING is sickening. It is a HELLISH story but no crime has been committed. IMHO.
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Question for Callan Road 02 Dec 2016 16:53 #8137

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Do not disagree with most of what you have just posted - however, there is some funny business going on with the stock price - no way that the market cap s/b 30 million - also, I own both, but no way ATHX is worth 4 to 5 times what CYTX is worth - b/t/w, did you see that ATHX ended another terrible week at 1.56 (no apparent reason for the decline from the 2.20's in October???).

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Question for Callan Road 02 Dec 2016 19:12 #8138

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IMHO, ATHX is easily worth 20 times more than CYTX at this point and that gap will widen in the future. I've already explained why but maybe this http://cnafinance.com/athersys-athx-stock-exclusive-c-suite-discussion-with-dr-gil-van-bokkelen/12493interview will crystallize it.

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Question for Callan Road 02 Dec 2016 21:35 #8139

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If it walks like a duck and quacks like a duck it's a duck. Shame on you WST.

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Question for Callan Road 03 Dec 2016 06:46 #8140

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Wall Street Titan wrote: I disagree with those who suspect fraud. I see the failure as a series of mishaps that started with the failure to obtain a favorable 510k ruling. In retrospect, once they couldn't get this device approval path, the writing was pretty much on the wall. They were foolish to spend so much time and resources suing the FDA. It is clear in retrospect, that without the 510K approval the autologous model was a real long shot. Then they wasted resources on the souped up Celution One that went nowhere when they should have been going smaller and cheaper for breast reconstruction in the EU. Tigenix, another fat term cell company made the change to allogeneic and they obtained a nice partnership deal based on Phase III Fistula data. Capricor also saw the huge hurdles with autologous and switched over to allogeneic and they also got partnership money and CIRM funding for their heart cell therapy (among others). Athersys has scored three major partnerships with upfront cash - again allogeneic. Cytori may have been able to overcome this problem if they scored on OA. I was very surprised that they failed in the Phase II and I gave a few potential reasons (in adequate dosing, need for a biological matrix, randomness of donor cell viability, etc.). In retrospect, KT Lim was stupid for partnering with Cytori but Cytori was smart in taking his money - BECAUSE NO LEGITIMATE COMPANY CAME TO THE TABLE - again the autologous model was the main culprit. So this is NOT ABOUT FRAUD, IMHO. It's more about a series of poor decisions and a flawed business model from the outset. Management WAS guilty of overpaying themselves and overstaffing. Remember Clyde Shores and all the other overpaid execs that came and went? To think of how much money these guys made over the years for accomplishing close to NOTHING is sickening. It is a HELLISH story but no crime has been committed. IMHO.


Thanks WST- I read a lot of things that I see similarly, but as can be expected have a totally different view on the allo versus auto discussion.

On the 510K side I have a different view also- resolution of the Request For Designation as a 510K would have produced many copycats. The patent position Cytori has on Celution, never functioned anyway, so in hindsight the PMA device designation, probably as sole Company in the US ever, provides a major competitive device vs drug i.e. regulatory advantage.

Yes- the dumbasses suing the FDA was really stupid. They should have spent money collecting clinical PMA data- Rongside´s Crohn's fistula or anal fissures for instance would have been wonderful apps, which they KNEW worked great and would have been on the market now already.

I personally have a suspicion that the valuations of the allo cell companies are so tiny, since the therapeutic value of those brews is quite limited. As a Tigenix shareholder I was appalled by the 25 Mio they got for global fistula except US. The ATHX deals to me were peanuts also, for what they gave away. The MSB - Cephalon deal was sofar the only one of substance and size which is commensurate to what one would expect as future value. Calhoun almost managed the Daiichi Sankyo deal, which would have beaten the Cephalon deal handsomely if you believe Calhoun and no- I do not think he would lie.

From my perspective- the present allo products are the end of the development road- allo MSC cells lose their immunogenicity when the cell differentiate and would cause an HLA reaction. Major issues could crop up in my view. This is exactly where the potential for auto exists in my view, you can do something with cells to induce them to differentiate.
Anyway- that is future- the present we have - and I agree totally- due to the incompetence of present Cytori highly overpaid managers.
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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:

Question for Callan Road 03 Dec 2016 11:29 #8143

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Fas said that "Calhoun almost managed the Daiichi Sankyo deal, which would have beaten the Cephalon deal handsomely if you believe Calhoun and no - I do not think he would lie".

Fas. I am not disputing your comment, but I am totally unaware of that potential deal and find it incredible that it could have had such potential value. In what kind of forum did Calhoun make this known??

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Question for Callan Road 03 Dec 2016 12:57 #8145

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rodney.strongg wrote: Fas said that "Calhoun almost managed the Daiichi Sankyo deal, which would have beaten the Cephalon deal handsomely if you believe Calhoun and no - I do not think he would lie".

Fas. I am not disputing your comment, but I am totally unaware of that potential deal and find it incredible that it could have had such potential value. In what kind of forum did Calhoun make this known??


Rodney-

Believe it or not. In the past future "events" or information on past things, like this one, which did not happen, goes the round in lets say- major shareholder circles. I consider it a US pastime- insider knowledge, which is pursued by half the market and a lot of people are actually succeeding in getting this information, which gives them an unfair advantage.

I for one- do not want to know- and all the folks I am dealing with in the past years, are with me on that one. I must say- Hedrick´s crew has been a lot better on corporate governance, but he went to the extreme in only disclosing things when the financing is ascertained. Kind of the opposite stuff again, which I believe is totally wrong.

Anyway- I do know the numbers which were floating around- wont disclose them though. Just, believe me, they exceeded the MSB-Cephalon deal "handsomely" like I wrote, which - I must admit- also supports my believe in the technology and kind of assured me that my brain is still intact, despite all market action to the contrary..
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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:

Question for Callan Road 03 Dec 2016 14:02 #8146

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Companies do fail without fraud, don't they, Roth?

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Question for Callan Road 03 Dec 2016 15:09 #8147

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Fas, Thank you for your comments.

You are correct that 510K approval would have created many copy cats. But the fact of the matter is that many copy cats have been created anyway even though Cytori failed to achieve 510K. If they were successful under 510k, they could have capitalized on the huge private pay business that developed in the U.S. The first mover advantage would have propelled the share price to very high levels on the news and they could have cleaned up the balance sheet with cheap capital raises that could have been better positioned the company to pursue individual indications for full reimbursement.

"As a Tigenix shareholder I was appalled by the 25 Mio they got for global fistula except US. The ATHX deals to me were peanuts also, for what they gave away. The MSB - Cephalon deal was sofar the only one of substance and size which is commensurate to what one would expect as future value. "


I don't know the details of the Tigenix deal off the top of my head but I am very happy with the recent deals Athersys signed. I don't think you are being realistic in your assessment if you look at the total value of the agreements. Athersys got $10,000,000 up from Chugai for an option to go forward on the stroke trial in Japan. When they opted out, Healios came in with $15,000,000 up front for the rights to develop MultiStem for stroke, again, only in Japan. Under the deal, Healios pays for ALL clinical trial and development costs in Japan INCLUDING paying Athersys for MultiStem manufacturing costs for the doses they require. On top of that there are $30MM in development milestones and $185,000,000 in sales milestones under the the agreement. But the royalties are the HUGE numbers if this pans out. Mid teen royalties on 62,000 strokes at say $40,000 per dose would equate to an annual revenue stream of over $400,000,000 per year in pure pre-tax profit for Athersys for a company with a market cap of less than $150,000,000. I think that is a very, VERY lucrative deal for Athersys shareholders and a testament to the value Athersys has created with its allogeneic model. Again, this is ONLY FOR STROKE IN JAPAN.

"From my perspective- the present allo products are the end of the development road- allo MSC cells lose their immunogenicity when the cell differentiate and would cause an HLA reaction. Major issues could crop up in my view."

I disagree here also. If by differentiate you mean transforming into cells (e.g. neurons) and engrafting into a patient's body, that is not mechanism of action of MSCs or MAPC's (the autologous version of MultiStem). In fact, Arthur Caplan, the father of the MSC, recognized this and proposed that the "M" in MSCs should be changed to "Medicinal". I spent a great deal of effort studying the history and evidence that supports MultiStem for stroke in this article: seekingalpha.com/article/4005856-systems-go-athersys-pivotal-stem-cell-stroke-trial-japan-exploring-scientific-evidence . I would ask that you read it and let me know if we still disagree.

WST

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Question for Callan Road 03 Dec 2016 16:25 #8148

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WST, as I have posted, I am an owner of both CYTX and ATHX - however, I agree with Fas that the potential of auto is greater than allo - with all due respect, you seem to be currently enamored with ATHX in a way that you were enamored with CYTX not so long ago (as you wrote many very positive articles on CYTX over the years) - my feeling now is that you have given up on CYTX, and I think that is your right to do so particularly in light of the many disappointments and less than stellar management of CYTX - however, my only caution to you is that while ATHX may currently have a much higher market cap than CYTX, that can all change in short period of time with just a partnership or two for CYTX (similar to ATHX ) - obviously, I hope that there is success in the future for both companies, but I believe that auto will ultimately prevail over allo in totality. :really:

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Question for Callan Road 04 Dec 2016 07:48 #8149

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Wall Street Titan wrote: Fas, Thank you for your comments.

You are correct that 510K approval would have created many copy cats. But the fact of the matter is that many copy cats have been created anyway even though Cytori failed to achieve 510K. If they were successful under 510k, they could have capitalized on the huge private pay business that developed in the U.S. The first mover advantage would have propelled the share price to very high levels on the news and they could have cleaned up the balance sheet with cheap capital raises that could have been better positioned the company to pursue individual indications for full reimbursement.


WST- pls find the "thank you" for your comments returned :yep:

Unfortunately regulatory wise it could not have worked that way. You have to earn additional claims for an application on the device first before it can be marketed for that specific application. Calhoun wanted the 510K mainly, so that Universities in the US could do PI studies easily with an IRB. The huge private pay market (is it huge?- I do not know) is based on the assumption though, that fat cells like fresh BM cells are not regulated. Cytori knows better, since they asked the FDA themselves for an RFD on Celution. Therefore as a "serious listed outfit" could not participate in a market which is clearly illegal also when Celution had an 510K.

I don't know the details of the Tigenix deal off the top of my head but I am very happy with the recent deals Athersys signed. I don't think you are being realistic in your assessment if you look at the total value of the agreements. Athersys got $10,000,000 up from Chugai for an option to go forward on the stroke trial in Japan. When they opted out, Healios came in with $15,000,000 up front for the rights to develop MultiStem for stroke, again, only in Japan. Under the deal, Healios pays for ALL clinical trial and development costs in Japan INCLUDING paying Athersys for MultiStem manufacturing costs for the doses they require. On top of that there are $30MM in development milestones and $185,000,000 in sales milestones under the the agreement. But the royalties are the HUGE numbers if this pans out. Mid teen royalties on 62,000 strokes at say $40,000 per dose would equate to an annual revenue stream of over $400,000,000 per year in pure pre-tax profit for Athersys for a company with a market cap of less than $150,000,000. I think that is a very, VERY lucrative deal for Athersys shareholders and a testament to the value Athersys has created with its allogeneic model. Again, this is ONLY FOR STROKE IN JAPAN.


Of all this "impressive stuff" -At the very beginning stands ONLY 15 Mio for a company which like all other SC outfits tends to be starved of cash. If they would be really assured this was a goldmine, they would have paid with gold. They did not, so most is "pie-in-the-sky" just like Lorem is totally pie-in-the-sky.
This is where the issue is, in the allo field- the US government gave up on stockpiling Prochymal. Actually Genzyme and Boston Scientific left out on Osiris. Athersys lost their Cardiac partner and Pfizer. Chugai, after paying 10 Mio, still did not think stroke would be a goldmine. MSB just lost TEVA after Cephalon & TEVA themselves paid hundreds of millions on developing cardiac. In all these cases, the real experts, the professionals within those Companies have decided after dealing "hands on" with the technology.

Anyway- on the science. I think you did not get my drift on the last bit. In the past 10 years I probably read over 200 scientific papers on cell technology and am very conversant with Caplan. I know what he is saying and I feel I am comfortable with the technology in general and know the mechanisms of therapeutic action. If I were you, I would be a little worried that Alexey Bersenev, still has the 2009 MAPCs issues of reproducibility as the first scandal in the Adult Stem Cell Industry on his website. To me, Alexey is the only unbiased SC scientist who I know in the field.
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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:

Question for Callan Road 04 Dec 2016 16:38 #8150

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Fas,

Of all this "impressive stuff" -At the very beginning stands ONLY 15 Mio for a company which like all other SC outfits tends to be starved of cash. If they would be really assured this was a goldmine, they would have paid with gold. They did not, so most is "pie-in-the-sky" just like Lorem is totally pie-in-the-sky.


Comparing Healios to Lorem is not valid, IMHO, when you consider the relative expertise in regerative medicine of the two parties. KT Lim was a real estate developer and knew nothing more about stem cells than what he learned n a bar. Healios is backed by RIKEN , the premier research group in Japan and other large Japanese companies including Sumitomo Dainippon Pharma. Healios is primarily an iPSC company with great expertise in the field.That $15 million you dismiss is really more like $50MM of up front risk when you consider how much it will likely cost Healios to run the clinical trial and find out if MultiStem works on stroke. That sounds like gold to me if one has realistic expectations. The Healios investment and subsequent research seems more relavent to me than the fact that the problems with the original MAPC paper are still listed on Alexy's blog. I provided several links to many subsequent published works on MultiStem that have no scandals attached to them. Also, I recall that Caplan specifically mentioned Athersys and the allogeneic model as most likely to achieve commercial success after having seen all the data out there.

So I guess we disagree and that's fine. Time will tell. I am surprised that, based on your views on allogeniec, you still own Tigenix.

WST

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DOV´s Revised Projections for the Periods 2017 until 2020

Shareble link : HERE

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