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TOPIC: Darrell Francis complimentary at Forbes

Darrell Francis complimentary at Forbes 06 Aug 2014 12:40 #1984

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Well- first you have to know who Francis is- he is a UK scientist who has investigated several scientific papers on cardiac SC research and has hammered the stuff being written. Basically he discovered heaps of mistakes.

Larry Husten has kind of teamed up with Francis and criticizes a lot of what goes on-

on Cytori however he was very complimentary:

While it is always sad to hear that patients have suffered through volunteering in the interests of furthering science, in this case it is a relief to hear that 2 of the 3 have already recovered. It is carefully conducted research, and patient volunteers, who make the slow forward steps of science possible. Cell therapy has an enviably benign safety record. Indeed some cell therapy advocates seem to take delight (paradoxically in my view) in pointing out that the cells don’t persist inside the heart: they apparently vanish, leaving just an unexplained benefit. How might disaggregated cells cause problems of this nature in this study? That is why the focus will be on the amount of intraventricular catheter manipulation necessary, and the associated need for anticoagulation. These investigators are setting a good example of openness which will help advance the field, for the ultimate benefit of patients.


Link- Forbes article
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Darrell Francis complimentary at Forbes 06 Aug 2014 14:25 #1985

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Fas,
My question is this. if trial were stopped 2 months ago why were shareholders not advised. People were definitely aware and most likely shorted the stock knowing what would happen when Cytori announced as witnessed by AH trading. They cover and make a fortune. When an article like this comes out and gives some cover and stock recovers they make a fortune on the recovery. Where is the SEC ?

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Darrell Francis complimentary at Forbes 06 Aug 2014 15:13 #1986

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Michael-

I do not think the stopping of the clinic 2 months ago, was general knowledge or knowledge privileged for short funds.

The lack of announcements / communication I find somewhat disturbing too.

I will discuss on Friday with people more knowledgeable on SEC matters.

I will come back on this

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Darrell Francis complimentary at Forbes 07 Aug 2014 08:04 #1987

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Hi Fas,

As the 3 'problems' occured both in study and placebo population, one can think it is not related to the SC but to the treatment itself or just the patients' health conditions...

You had a good friend who was present at the annual meeting and the hours before/after.
Did he/she give some more info you can share?

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Darrell Francis complimentary at Forbes 07 Aug 2014 09:02 #1988

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Belgium-

At the shareholders meeting this was NOT topic of discussion. The FDA questions triggered the announcement, as you can read in the Forbes article.

The issue should be crystal clear- especially from the statement by Franciss-

Darrel Francis, a UK cardiologist who has been critical of much stem cell research, told me that a likely source of the complications was the use of electro -anatomical mapping, which involves moving the catheter around in the left ventricle to find a good place to treat. “Dangling catheters in the left side of the heart does have a stroke risk, and is seen – for example – in AF ablation,” he said.


If you hoist cells 15 times from the leg to the left ventrical, patients are simply prone to mild stroke cases. You either REDUCE the number of injections or change the patient profile.

Very simple to change the protocol accordingly. However this should have be known before- that this risk exists, and yes my friend heard that from some experienced Board members also. :whistle:
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Darrell Francis complimentary at Forbes 07 Aug 2014 10:57 #1989

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Hi Fas,

I was referring to peripheral action/info potentially gained at the meeting.
You told us you would see what could be disclosed I think...

Thanks

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Darrell Francis complimentary at Forbes 07 Aug 2014 11:15 #1990

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Oh.. I see what you mean.

No- that is impossible. Public boards are not there for this purpose.

I was informed that the BOD promised answers on the questions though and although I do not expect anything this week with the Q-Call upcoming, I think in 1-2 weeks I can share a lot of stuff, that probably most of you were not aware of. :vegas:

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Darrell Francis complimentary at Forbes 07 Aug 2014 11:52 #1991

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Fas, it quite clearly appears that the hold on the ATHENA trials emanates from the mechanical aspects of the treatment. There is nothing to indicate that the ADRC themselves contribute in any way to the complications. Perhaps the patients in the previous Precise heart trials were just fortunate or were less sick. Moving a catheter in and out of the artery 15(?) times for the requisite injections is a form of abuse .......... however well intentioned. It would be nice to have a more detailed description of the procedure........... maybe I'm just an info junky or have too much invested in CYTX.

Anyway, thank God for Timothy Henry and the Forbes article because if we were dependent on IR then :bash:

As for the review of the existing protocol, while it is possible to treat less sick patients, that would be self defeating. The whole idea is to give hope and a better quality of life to those patients that are close to degenerating further and thus progressing to require a heart transplant or LVAD. We already appear to have interest in patients with LVAD for whom serious complications are a fact of life.

Perhaps they should look at the possibility of making fewer injections with a larger volume of cells injected into the area closest to the damaged area. It is my understanding (not certainty), that Mesoblast's stage three trial which is being undertaken by TEVA entails a SINGLE LARGE injection of cells. While not optimal it would circumvent the necessity of multiple injections and therefore movement within the ventricle and reloading of the catheter with cells?

This HOLD is not a negative in that we can now pre-emptively deal with complications that would no doubt need to be faced in the future.
What is clear though is that CYTX cannot fund this trial and a stage three Pivotal with incremental share issues at low prices. They need to partner. If not in this indication, then in some other one. This management and its BoD has to understand that they have a huge opportunity, but that wanting to have your cake and eating it is not possible.

The opportunity provided by ADRC is huge, the potential payoff is huge, but greed, wanting it all is a mistake. Negotiate, no ones asking for them to capitulate. One way or another we the shareholders of CYTX will not get it ALL. But we are seriously tired of getting nothing.

A well constructed and fair (to both parties) partnership deal in some indications (not necessarily all) means we get less of the cake......... so does issuing shares ad infinitum ........... the deal however will most likely ensure that we see the beginning, and end of a successful stage three in our lifetimes.
:cool:
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Darrell Francis complimentary at Forbes 08 Aug 2014 03:01 #1993

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The fact that the stock went down again on Thursday was a bit surprising- but not if you assume some folks see trouble on the disclosure side of things... :whistle:

The piece by Henry McCluster, who most of you will know- Link- here

History now repeats itself - albeit in a less dramatic fashion– as the market asks “what did CYTX president and CEO Marc Hedrick know (about the Athena clinical trial holds) and when did he know it?

Which then raises the obvious – why did Cytori NOT reveal this fact to investors before closing of its most recent offering which of course is required under SEC disclosure rules?



The timeline suggests that further disclosure was warranted!

Let’s take Timothy Henry, the co-principal investigator and director of Cardiology at Cedars Sinai … at his word that the HOLD was put into place two (2) months ago. Before such a decision is made, it takes approximately 45 days prior for the Food and Drug Administration to initiate and conduct a review. Then add in the 2 month denominator!

If I was an investor, I’d really like an answer, especially as CYTX closed a $10 M registered direct unit offering a little over 2 months ago (5/30/2014).

It’s logical to assume CYTX knew, at a minimum … of the adverse patient events (strokes) triggering the review and, at worst, that the clinical hold would be in place BEFORE it went ahead with its $10 M raise from issuance of $4.05 M shares at $2.47 each and 4.05 M warrants for shares of common stock that are exercisable immediately upon issuance at $3.00 per share?



According to the Securities and Exchange Commission

“An issuer is obligated to update and supplement any such disclosures with additional information and must provide disclosures regarding material changes in the issuer's affairs that are not covered in documents furnished to purchasers.”


The Bottom Line: The “ambulance chasers” are going to be checking out whether CYTX’s officers have an extra set of jockey shorts available; possibly launching investigations as to whether the shareholders lost any money in relation to their investment in CYTX to possibly “set-up” a class status!

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Darrell Francis complimentary at Forbes 08 Aug 2014 05:10 #1995

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however well intentioned. It would be nice to have a more detailed description of the procedure........... maybe I'm just an info junky or have too much invested in CYTX.


I will ask Mac to elaborate his procedure a bit on the Board.

As for the review of the existing protocol, while it is possible to treat less sick patients, that would be self defeating. The whole idea is to give hope and a better quality of life to those patients that are close to degenerating further and thus progressing to require a heart transplant or LVAD. We already appear to have interest in patients with LVAD for whom serious complications are a fact of life.


Of course we should try to help sick patients- from a "strategic perspective" in helping mankind- the choice for an ACUTE MI procedure with ADRCs simply to me is much much more appealing and basically should prevent patients from getting in that spiraling CHF issue. Goal should be that folks simply die from old age instead of heart failure. One of the basic issues that I have with present management, of which Hedrick is now the most prominent member.

Reading the Kolbert points between the lines- he is thinking similarly. :bye:

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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:

Darrell Francis complimentary at Forbes 08 Aug 2014 07:28 #1996

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***Reading the Kolbert points between the lines- he is thinking similarly***

Sorry Fas...I havent seen his latest report...are you saying JK's thinking on the acute side or the failure patients ?
Curious, because at one point in the past JK didnt think Cytori's approach was going to win on the acute side vs a off the shelf method.

BTW...whats his 2020 cardiac revenues now....LOLOLOL !!!
I always loved his fantasies there.

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Darrell Francis complimentary at Forbes 08 Aug 2014 07:57 #1997

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No- I meant the "fixing of the Companies strategy by a new CEO" more than anything else. I just read his stuff very broadly/quickly, since I am not all that interested what he writes.

That one caught my eye though. :yep:

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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:

Darrell Francis complimentary at Forbes 08 Aug 2014 08:59 #1998

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Fas, can't object to your rational for why treating Acute is better for mankind than treating Chronic. Having said that, they chose to go with chronic. Lets hope that they resolve the issues and announce their findings, changes, rational and explain why the pain we have just gone through will work to our advantage in the end.

With regard Acute perhaps an announcement about the results to date in ADVANCE may be forthcoming? Hope/pray they are good!

Wit regard the class action lawsuits etc. these normally occur at the bottom ........... or the end.........

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Darrell Francis complimentary at Forbes 08 Aug 2014 09:07 #1999

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A little off topic but Mesoblast just got approved for an NIH LVAD heart trial and an email from the company states that it is funded by NIH. 120 patients versus Cytori's 34 for the same indication that we recently heard about. online.wsj.com/article/PR-CO-20140806-918325.html

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Darrell Francis complimentary at Forbes 08 Aug 2014 09:47 #2000

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John- I did find Mac´s posts on his procedure at the YMB through the search tool-

Just got back from the Heart Clinic. Had lipo on my stomach, and either stem cells or placebo shot into 15 different locations on my heart. Will send more info regarding my portion of the Athena clinical trial over the next few days, when I start feeling better

Started looking into the Athena trial in January. Decided not to do it, because if you received the placebo you would not get the stem cells later. Seemed like a lot of hard work with no gain. I would just wait and save up to get the stem cells from a approved clinic in another country.

After some back and forth thinking I decided to go ahead and volunteer with the hope that Cytori stem cell system would be approved in the future. Went to the Florida Hospital Tampa-Pepin Heart Institute at the beginning of April to take the many different test to prove I was qualified for the Athena test.

On April 23, 2014 at 05:30 am, I checked into the Institute for the operation. If your thoughts go along with a little time for lipo suction, half hour of Celution® and a few minutes of stem cell injection, what a surprise I have for you. At 6 am I was flat on my back and the next time I would be able to move would be 11 pm. Also had no food or water for 26 hours. The first operation was the lipo suction that took about one hour. My times during all events may be off because I was not awake during the operations.

Next I had to wait 3 or 4 hours for the Celution procedure. (not 30 minutes).

The stem cell injections took about 4 hours. The doctor mentioned he had to go up the catheter about two hundred times to be able to inject my heart with a needle in 15 different locations.


My comments: The time in between lipo and catheder could relate to the blinding procedure- there must be an independent manager taken care of the whole "cover-up" so that doctors remain blinded.
I do not understand the 200 "movements" for 15 injections- but that sounds pretty long and somewhat "invasive" for a non-invasive procedure.

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Darrell Francis complimentary at Forbes 08 Aug 2014 09:55 #2002

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Mac´s post on the follow- up of his treatment was as follows:

Just got back from my first visit, post operation. They looked at my battle wounds, took out a couple of small stitches, took blood, and put a heart monitor on me for the next 24 hours. They also asked how I feel.
The good news comes from that wonderful place called the rumor mill.
Not only are the patients saying they feel much better, but they are showing it with their actions.

My understanding is pre operation the patient could barely walk, now months later they are walking and feeling good about it.
Other news. Cytori is now talking about (note talking about) cross over. (Meaning you can get the real operation if you had the placebo after the study is done.) Hopefully that will get more people to volunteer for this study.

For those that want a guess, on how long it will be for the study to be completed. It will be six months, plus administration time after the last patient is finished with trial. I have not heard a rumor that I am patient number 45 so figure it will be more then six months from now.
I believed in this before I took the jump, but after today, if it is possible, I believe in Cytori stem cell 100% more. My honest opinion - if you can hang tight - don't sell, and buy some when you can.


I like the fact that Mac is really upbeat and believes in his treatment. I would too, having trained myself in listening "to my body" intensively thru the years. Helps me believing in ADRCs for cardiac too. The survival numbers of PRECISE were very indicative and good. Its heart-breaking reading such a POOR paper on "3 years PRECISE".
But thats something different... :evil: :bang:

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Darrell Francis complimentary at Forbes 08 Aug 2014 10:16 #2003

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Encouraging to see that Mac is doing well but the one big problem is we have no way of knowing whether he received ADRC treatment or the placebo. I realize we are all aware of this but it needs to be reiterated.

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