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TOPIC: Neuropathic Diabetic Foot ulcERs (REGENDER)

Neuropathic Diabetic Foot ulcERs (REGENDER) 28 Feb 2018 07:29 #11418

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Just one more trial that you may or may not be familiar with. Has already started enrolling one year ago. Expected data is this time next year.

Good size trial phase 2 trial.(45 patients)

clinicaltrials.gov/ct2/show/NCT02866565?term=adipose&recrs=abdf&cntry=FR&rank=7

The number of potential indications capable of being treated by SVF is huge, with substantial cost savings to healh care systems worldwide.

Marseille is really spinning the centrifuge.

I wonder what sort of value would be ascribed to all these IIS trials/indications should the scleroderma indication be approved.

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Neuropathic Diabetic Foot ulcERs (REGENDER) 01 Mar 2018 12:16 #11427

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rongside wrote:
I wonder what sort of value would be ascribed to all these IIS trials/indications should the scleroderma indication be approved.


Yes- that was obviously also the whole idea about my "what if" thread, what if when money was available to develop 2-3 other apps, which would be no-brainers. To me still- just like diffuse in case it was not under-powered.

Anyway- your post inspired me to bring the Naples study article back on this site, since it was a truly amazing study with incredible results, which can be easily seen by any layman from this image:



the article you can read here: HERE

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Neuropathic Diabetic Foot ulcERs (REGENDER) 02 Mar 2018 04:13 #11435

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As probably most readers here know, I am not a fan of present conventional medicine and nutrition guidelines, which without any success tries to reduce the steady increase in cardiovascular deaths and ever increasing diabetes epidemic. The latter in my view (specifically insulin resistance) being the root cause of poor cardiac health on the globe and not the risk factors identified by population studies in the fifties, like Framingham.

The wound healing studies from Akita and this one from Naples treated diabetic wounds and actually the PRECISE CHF study also treated mainly diabetics and were all rather successful.

I am leaning now to the explanation that the vasculature of diabetics is rather "leaky" like with cancer patients and the cytokines responsible for the paracrine therapeutic action of ADRCs can more easily "access" the tissue micro-infrastructure of diabetic patients and do their regenerative work.

From a strategic perspective, that would mean that the Arab countries, like the UAE, would be an excellent market for the technology, since it has by far the highest rate of diabetics on the globe i.e. Calhoun & Co have got that right.

I recently found first scientific evidence that support that view of high glucose blood levels causing endothelial dysfunction_

Abstract
Vascular endothelial dysfunction leading to increased risk of coronary artery disease, peripheral vascular disease, and impaired ability to respond to tissue ischemia remains an important clinical problem in type 2 diabetic mellitus (T2DM) patients. Hyperglycemia, a major causative factor in T2DM, is among causes leading to these vascular complications, although the underlying mechanisms of dysfunction are not well understood. It is known that early intensive glycemic control reduces the risk of vascular complications during T2DM; however, there is a large gap in studies of the etiology of hyperglycemia-induced endothelial dysfunction. T2DM patients with a high glycation index of hemoglobin A1C (HbA1c) have a greater risk of microvascular and macrovascular complications, suggesting there is a correlation between hyperglycemia-induced glycosylation and the progression of T2DM vascular complications. Clinically, HbA1c glycosylation levels have been used as a predictor of retinopathy, nephropathy, and cardiovascular complications and lowering HbA1c glycosylation levels correlates with improved vascular phenotypes. These studies suggest that high levels of blood glucose correlate with biochemically favorable Maillard reactions that cause spontaneous glycosylation events in the vasculature. The objective of this study was to expand our knowledgebase on the influence of hyperglycemia-induced glycosylation events in the vascular endothelium and its contribution to the onset and progression of T2DM. Initial characterization of the effects of hyperglycemia on ex vivo vasodilation and in vitro tube formation assays exhibited impaired endothelial phenotypes. In addition, enzymatic removal of glycosylations on the endothelial cell surface was able to restore normal phenotypes. In order to identify specific mechanisms behind the observed endothelial impairment a combination of glycoproteomic, phosphoproteomic, and genomic methodology was used on normal and high glucose treated rat microvascular endothelial cells. These analyses revealed differential glycosylation of important endothelial cell surface receptors, ion channels, and adhesive protein targets; including the angiotensin II (AT1) and serotonin (5HT-2A) receptors. Additionally, further analysis of gene expression and the synergistic balance between intracellular O-GlcNAcylation and phosphorylation of treated rat endothelial cells indicated alterations of vasoreactive pathways, inflammatory factors (IL6, IL1R1a), and VEGF signaling important for endothelial function. Overall, this study identified multiple hyperglycemia-induced endothelial signaling alterations that potentially contribute to peripheral vascular disease in T2DM..

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Neuropathic Diabetic Foot ulcERs (REGENDER) 02 Mar 2018 06:23 #11436

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Thanks Fas...I do remember these.
***In six of 10 cases there was complete healing of the ulcer***
So why wasn't the medical community jumping up and down wanting to pursue this ?
Its been 5.5 years...we know others have studied this.

BTW...I still say the chronic burn wound is where this should be used...still say it wont be SOC for burns.

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Neuropathic Diabetic Foot ulcERs (REGENDER) 02 Mar 2018 12:03 #11437

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myownhedgefund wrote: So why wasn't the medical community jumping up and down wanting to pursue this ?
.


Good question- I can offer two explanations,
first, conventional medicine like the monstrum they built between the fifties nad seventies (Ancel Keys etc)- it provides them billions of income and they are not really looking for solutions- example? - of course- the infamous LDL riskfactor-

In 121,000 US people having had heart attacks, 62% of men and 53% of women had none or only one coronary risk factor as determined by Framingham. Sixty-three per cent of the US population have none or one coronary risk factor, and most persons with one or more coronary risk factors will never develop coronary heart disease. The Norwegian Hunt 2 study (>500.000 man years) even concluded that low LDL was detremental to the coronary risk of women. In four major studies, more than 75% of all hard coronary events occurred in persons classified as low or intermediate risk, and the majority of persons classed as high risk had no coronary events. Risk score assessment alone is inadequate in predicting individual coronary risk.


With diabetes things are similar- Type 1 and 2 patients are still advised to load up with carbs- I presume to jack up the sales of Metformin and insulin.

Anyway- my second reason is more mundane- Cytori never announced the study. They were spending all their dough on ATHENA and were bewildered by the European chaos on device regulations. That is better now with the AMTP rules.

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Neuropathic Diabetic Foot ulcERs (REGENDER) 02 Mar 2018 15:58 #11438

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I hear you on the established medical community but someone could still have made a bundle with a clinic and you would think insurance companies would be all over it. Even back in the day when this was first actively discussed I thought maybe only 5% of the market was going to be available to them...5% of the wound care market is still fairly decent.

When they never could support the PPS and the constant need for cash why didn't a better quality of analyst get involved here to push these points ? Sadly my thinking over the years has become more suspicious beyond the bozo factor.

I do want to push back on the carb factor with DM on this side of the pond.
Carb restriction is extensively taught for DM.

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Neuropathic Diabetic Foot ulcERs (REGENDER) 02 Mar 2018 19:24 #11439

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Ownership is all.

It is not the job of insurance companies to create medical treaments/drugs. Gift independent researchers cannot generate a drug approval process/decision on their own. Analysts worth their salt abondon coverage of companies that are not worthy of their time. Their bosses do not pay them o give direcion o failing companies. The only analysts that deal with CYTX do it because they make money.........Maxim:evil: CYTX has had ownership of this technology but has simply been unable to monetize it. Management had dreams of ruling the medical world. They were going to cure heart disease. Little did they know about the complexity and cost of running such trials. They committed to a course of action that sucked up all their(our) capital & time. Instead of going for low hanging fruit they shot for the moon, and didn't even make it out of the troposhere, much a less the stratosphere. Out of money, out of fuel, out of time, in debt..................

Their delusional expectations of the potential of ADRC/SVF prevented them from concluding a deal. Don't get me wrong, the potential IS there but their hubris (incompetence) drove off whoever would have wanted to deal with them.

Also lets not forget that there was/is still a considerable amount of angst re autologous ADRC/SVF as this is a paradigm shift in how patients are treated and there is/was no roadmap for the approval or reimbursement process (the FDA made policy ad hoc on the basis of dealing wih issues as they cropped up, all while trying to protect the BP/BB business model of which it was a part)

It could have all been so different if management had not been so ambitious/greedy/hubris, and simply gone for a more simple indication eg. PAD. Even when they get it right the execute poorly: All they had to do was focus on diffuse scleroderma, but again they wanted the big market, Raynaud's and limited scleroderma. A greater focus on the group that was most likely to benefit (and be reimbursed) and a few more patients would most likely have given the STAR trial stellar results.

Cheaper trials validating the technology and treament would have brought them and us riches ........... they at least got their salaries, free options and most probably golden parachutes. We will be lucky to get xx cents on the dollar.

This technology/company must be sold as the evidence to date leads to the conclusion that even with successful phase 3 trial data it is unlikely that this management team(?) can commercialize it. Given the plethora of issues arising from the uniqueness of this treament paradigm, any serious interest would be predicated on control/total ownership.

The question is whether this company is transferred to new ownership with a modicum of concern/inerest for the shareholders, or not?

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Neuropathic Diabetic Foot ulcERs (REGENDER) 02 Mar 2018 19:45 #11440

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***It is not the job of insurance companies to create medical treaments/drugs.***
No kidding, LOL and was not what I was suggesting.

As far as path and monies....I wonder if suggestions were made long ago that were completely ignored ?

Of course the current best path forward for the tech is a out right sale....we will get little. Certain top company players will want protections and even then unknown if someone would want them. Fas' EU axis may be the only tolerant ones...LOL

Near term on the call I will look for:
1. FDA meeting confusion to be cleared up.
2. Outstanding share count issues
A. Current float
B. Future authorization

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Neuropathic Diabetic Foot ulcERs (REGENDER) 04 Mar 2018 06:34 #11441

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rongside wrote: Ownership is all.

This technology/company must be sold as the evidence to date leads to the conclusion that even with successful phase 3 trial data it is unlikely that this management team(?) can commercialize it. Given the plethora of issues arising from the uniqueness of this treament paradigm, any serious interest would be predicated on control/total ownership.

The question is whether this company is transferred to new ownership with a modicum of concern/inerest for the shareholders, or not?


John, the big question in my mind is whether our judgment on the capabilities of management is not part of the "master plan" and drives us to make that conclusion, that the tech would be better off in other "ownership". The appearance of the Swiss, seem to indicate that financial backing for "third parties" originates from that country. Whether its Celactive or other parties, one cannot tell for sure of course, but for me the coincidence is too great. I presume we will see a lot of selling by the Swiss in the near term, to impress the trading folks, but surely the shares will end up with "interested parties", which does not bode well for shareholders.

Anyway- I never believed the stories that Calhoun couldnt be in the same room as Hedrick. That is very un-business like for CEO´s. Therefore instead of providing Celactive with a licence, which would have saved us probably half of the OS shares, I strongly suspect another type of collusion now.

Time will tell.

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Neuropathic Diabetic Foot ulcERs (REGENDER) 04 Mar 2018 09:35 #11442

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fas wrote:

rongside wrote: Ownership is all.

This technology/company must be sold as the evidence to date leads to the conclusion that even with successful phase 3 trial data it is unlikely that this management team(?) can commercialize it. Given the plethora of issues arising from the uniqueness of this treament paradigm, any serious interest would be predicated on control/total ownership.

The question is whether this company is transferred to new ownership with a modicum of concern/inerest for the shareholders, or not?


John, the big question in my mind is whether our judgment on the capabilities of management is not part of the "master plan" and drives us to make that conclusion, that the tech would be better off in other "ownership". The appearance of the Swiss, seem to indicate that financial backing for "third parties" originates from that country. Whether its Celactive or other parties, one cannot tell for sure of course, but for me the coincidence is too great. I presume we will see a lot of selling by the Swiss in the near term, to impress the trading folks, but surely the shares will end up with "interested parties", which does not bode well for shareholders.

Anyway- I never believed the stories that Calhoun couldnt be in the same room as Hedrick. That is very un-business like for CEO´s. Therefore instead of providing Celactive with a licence, which would have saved us probably half of the OS shares, I strongly suspect another type of collusion now.

Time will tell.

/

Fas, curious as to what your solution would be for the CYTX dilemma and how you would like events to unfold. Not my preference, but I would accept a takeover that would be at least $5 per share (assuming a BP-type deal), but I would prefer a combination with a biotech firm that is of a moderate size and with an expertise that a continued investment therein might eventually yield the inherent benefits buried deep within CYTX (and some day return our losses in this terribly managed Company).

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Neuropathic Diabetic Foot ulcERs (REGENDER) 04 Mar 2018 12:23 #11443

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rodney.strongg wrote: Fas, curious as to what your solution would be for the CYTX dilemma and how you would like events to unfold. Not my preference, but I would accept a takeover that would be at least $5 per share (assuming a BP-type deal), but I would prefer a combination with a biotech firm that is of a moderate size and with an expertise that a continued investment therein might eventually yield the inherent benefits buried deep within CYTX (and some day return our losses in this terribly managed Company).


In my view- in case a take-over happens, a 5$ price is illusional (as I have explained before) my best case scenario, is that the Swiss investment is based on anticipated events, which we do not know about, but led them to invest i.e. no takeover ambitions I give this scenario 20% odds.
Second scenario, that they really are just interested in gaining board influence (dismissal of Rickey etc) and pressure to provide Celactive with a fair price for a general license in certain countries (middle East etc) and a global licence for cardiac . Also i give this 20% chance.
Remains 60% for a takeover at the lowest possible price.
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Neuropathic Diabetic Foot ulcERs (REGENDER) 04 Mar 2018 12:59 #11444

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fas wrote:

rodney.strongg wrote: Fas, curious as to what your solution would be for the CYTX dilemma and how you would like events to unfold. Not my preference, but I would accept a takeover that would be at least $5 per share (assuming a BP-type deal), but I would prefer a combination with a biotech firm that is of a moderate size and with an expertise that a continued investment therein might eventually yield the inherent benefits buried deep within CYTX (and some day return our losses in this terribly managed Company).


In my view- in case a take-over happens, a 5$ price is illusional (as I have explained before) my best case scenario, is that the Swiss investment is based on anticipated events, which we do not know about, but led them to invest i.e. no takeover ambitions I give this scenario 20% odds.
Second scenario, that they really are just interested in gaining board influence (dismissal of Rickey etc) and pressure to provide Celactive with a fair price for a general license in certain countries (middle East etc) and a global licence for cardiac . Also i give this 20% chance.
Remains 60% for a takeover at the lowest possible price.


Why would Hedrick/Tiago/BOD go along with a takeover at the lowest possible price (your 60% possibility) unless the RO deal and the resulting conversions are a conspiracy to take away control from the existing s/h base - that would mean that there would be more significant holders such as the Swiss conversions in order for this to be accomplished (yet you give the Swiss interests only a 20% chance of being involved in any takeover attempt). I agree that a BP attempt at $5 or more is likely pie-in-the-sky thinking right now, but I really believe that any takeover particularly at a lower price will have to provide the ability of Hedrick/Tiago/BOD and the existing S/H base to benefit through continued stock ownership post any acquisition.

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Neuropathic Diabetic Foot ulcERs (REGENDER) 04 Mar 2018 23:15 #11445

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Fas, the ''Swiss'' are just custodians. We as yet do not know for whom.

I personally find it quite hard to believe that someone would buy a large stake to pressure Hedrick to give them a good deal for Middle East or cardiac (Celactive). If someone is that interested they would go for a full takeover. Also the fact that they could buy such a large share of the RO, convert, and not cause a poison pill issue smacks to me of collusion. :evil:

We are on the same page concerning a low ball takeover offer. However it may well be more subtle like giving away the crown jewels for a pittance under the guise of a shitty partnership or ROW licensing deal to acquire ''needed'' capital. Let us also not forget that we do not know if there are any additional (related) large holders of notes that have not yet been converted. Perhaps the takeover is already complete. Perhaps the conversion of notes was undertaken to ensure the requisite shares were available to vote as needed. Who says the existing BoD members were ejected? Personally I see this as a nice get out of jail card.......and there is nothing to stop them from investing in the future (assuming they have not already done so via proxies).

Just so that everyone undersands the magnitude of the value inherent in SVF/ADRC I attach a link to a trial being underaken by the Mayo Clinic. It is randomised and blinded. As it is very small one should be careful to make assumptions when the data is published. It addresses a HUGE market opportunity concerning a medical condition that will afflict more and more people given demographic trends. ...ie Pressure Ulcers that require hospitalisation.

clinicaltrials.gov/ct2/show/NCT02375802

Market opportunity:

leafhealthcare.com/pdfs/LH_WP_FinancialOverview_1563AB_101316.pdf

Alhough CYTX is not specifically mentioned as being a part of this trial, we all know through a HUGE number of independent trials conducted globally that ADRC/SVF are very effecive in wound healing. Using the Celution device negates the need for CGMP approved facilities. The Mayo Clinic has already stated that the Celution device is the BEST available option for SVF extraction. Celution's ability to process larger volumes of SVF than in the trial provides the doctor with the capability of securing a larger quantity of SVF for re-dosing if necessary.

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Neuropathic Diabetic Foot ulcERs (REGENDER) 05 Mar 2018 05:22 #11446

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rongside wrote: Fas, the ''Swiss'' are just custodians. We as yet do not know for whom.

I personally find it quite hard to believe that someone would buy a large stake to pressure Hedrick to give them a good deal for Middle East or cardiac (Celactive). If someone is that interested they would go for a full takeover. Also the fact that they could buy such a large share of the RO, convert, and not cause a poison pill issue smacks to me of collusion. :evil:

We are on the same page concerning a low ball takeover offer. However it may well be more subtle like giving away the crown jewels for a pittance under the guise of a shitty partnership or ROW licensing deal to acquire ''needed'' capital. Let us also not forget that we do not know if there are any additional (related) large holders of notes that have not yet been converted. Perhaps the takeover is already complete. Perhaps the conversion of notes was undertaken to ensure the requisite shares were available to vote as needed. Who says the existing BoD members were ejected? Personally I see this as a nice get out of jail card.......and there is nothing to stop them from investing in the future (assuming they have not already done so via proxies).

Just so that everyone undersands the magnitude of the value inherent in SVF/ADRC I attach a link to a trial being underaken by the Mayo Clinic. It is randomised and blinded. As it is very small one should be careful to make assumptions when the data is published. It addresses a HUGE market opportunity concerning a medical condition that will afflict more and more people given demographic trends. ...ie Pressure Ulcers that require hospitalisation.

clinicaltrials.gov/ct2/show/NCT02375802

Market opportunity:

leafhealthcare.com/pdfs/LH_WP_FinancialOverview_1563AB_101316.pdf

Alhough CYTX is not specifically mentioned as being a part of this trial, we all know through a HUGE number of independent trials conducted globally that ADRC/SVF are very effecive in wound healing. Using the Celution device negates the need for CGMP approved facilities. The Mayo Clinic has already stated that the Celution device is the BEST available option for SVF extraction. Celution's ability to process larger volumes of SVF than in the trial provides the doctor with the capability of securing a larger quantity of SVF for re-dosing if necessary.

Comments?

/

First of all, the poison pill was not enacted because the REAL share count was considerably higher when all the eventual Pfd. B conversions were considered (which makes total sense). Secondly, the idea of giving away the crown jewels for a pittance makes absolutely no sense - why would Hedrick/Tiago/BOD and the existing shareholder base go along with any such thing - if there is a low ball offer from another smaller biotech or similar firm (I don't think a BP-type offer is likely), you can be sure imo that all those parties will participate through a s/h interest in any post-acquisition success.

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Neuropathic Diabetic Foot ulcERs (REGENDER) 05 Mar 2018 06:18 #11447

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rongside wrote: Comments?


Agree with everything written. As I mentioned before, the whole design of the RO was as such to allow big stakeholders in, which did not have large stakes before. Collusion no doubt. And if you look at the chart of the past 4 years and consider the (deliberate???) toxic financing all that time, one wonders if this has not been in the making for all that time.

Very well possible that there are now holders at small prices, which together with the Swiss could have a majority stake.
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Neuropathic Diabetic Foot ulcERs (REGENDER) 05 Mar 2018 06:52 #11448

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Rodney here is the definition of collusion:

www.dictionary.com/browse/collusion?s=t

Firstly let me say that I do not know if there is collusion. Having said that, I do not expect such parties (management?) to warn me/us before hand, or during ........ My suspicion is that they have been making/executing a deal for quite some time (at least from the latest RO).

As for the shareholder base preventing whatever is being perpetrated at its expense, what exactly do you suggest? Short of having a large enough shareholding to exert ownership control at the board level there is very little we can do ... yet.

The nature of our participation, or not via a remaining shareholding interest is dependent on ones relative ownership position. Dilution has already destroyed our invesment. Who is to say dilution is finished? Unless you have been aggressively dollar cost averaging at these levels getting your capital investment back will be a miracle in itself.

Also here is an explanation of basic poison pill provisions.

www.investopedia.com/terms/p/poisonpill.asp

After a bit of simple thought on the subject I have come the conclusion that the poison pill provision is a joke. It is not designed to protect failling biotechs. Providing an opportunity to a huge number of dissafected small shareholders to participate in purchasing new shares at a discount to that paid by the ''bidder'' is a nonsense for a small undercapitalised biotech that is always with its back to the wall with regard financing. Anyone see a bid yet? Smacks of an aggreed ownership transfer to me.

My question is what have they been doing to seriously shop the company to interested parties BEYOND their mates, or Maxim's. Everything to date indicates that they have not promoted it properly (if at all).

Diabetic foot and pressure ulcers .......... what is that worth? Why have they been dragging their feet with BARDA when wound indications are so clearly well suited to ADRC/SVF treament. This goes well beyond incompetence.

Fas, as you know there is a substantial percentage of the RO notes that have not been exercised/converted into common it would not surprise me in the least if these are beneficially owned by the same group, and majority control has already been effected by the Hedrick/Kolbert cabal. Throw in a few offshore nominee companies accumulating shares below 5% and the rest is history. :evil:

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Neuropathic Diabetic Foot ulcERs (REGENDER) 05 Mar 2018 08:37 #11449

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Rongside, I know what the definition of collusion means, and even this inept management and BOD is not stupid enough to risk jail time for CYTX.

When I refer to the existing shareholder base, I am obviously including the institutional ownership that had nothing directly to with the RO - do you think that they will just standby and lose their interests.

Your poison pill comment does nothing to enlighten the discussion (particularly since you are the one that brought up that issue in your first post).

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Neuropathic Diabetic Foot ulcERs (REGENDER) 05 Mar 2018 11:46 #11450

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“RO - do you think that they will just standby and lose their interests.”

I already addressed this question RS and as FAS pointed out, at the present pps, it wouldn’t be worth their time to pursue it, even for the largest fund holder.

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Neuropathic Diabetic Foot ulcERs (REGENDER) 05 Mar 2018 12:17 #11451

  • rodney.strongg
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b767cpt wrote: “RO - do you think that they will just standby and lose their interests.”

I already addressed this question RS and as FAS pointed out, at the present pps, it wouldn’t be worth their time to pursue it, even for the largest fund holder.


B-7, with all due respect, you are missing the entire point of the discussion.

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Neuropathic Diabetic Foot ulcERs (REGENDER) 05 Mar 2018 19:12 #11452

  • rongside
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Rodney, as per your 20/2 post:

Did you ask him how they were able to accumulate 11 million shares w/o affecting the price dramatically - had to come out of other institutions and/or somehow the RO was part of the equation - did you ask him how CYTX feels about an affiliated group owning 25% of the Company (a real poison pill issue) - it all makes no sense unless the Company knows more about what is going on and is not revealing anything at this point (did that trigger Rickey & Naughton to resign) - could turn out to be good news in the end, but I wish that I had a clearer picture.


The poison pill issue has often been mentioned (not only by me) without necessarily being understood. My point was that in the case of small cash strapped biotechs it is not truly relevant. Even if it could be used (doubful) it would only be exercised if here was a hostile element in their actions as perceived by management : there does not appear to be any such perception on their part.

As regards ''other'' institutional investors intervening there is only Perkins Captial Management with a substanial holding and CYTX is only 0.7% of their porfolio as at EOY. No cavalry coming.

My question remains: what have they been doing to seriously shop the company to interested parties BEYOND their mates, or Maxim's. Everything to date indicates that they have not promoted it properly (if at all). :evil:

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