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TOPIC: Is BARDA as important as it has been portrayed?

Is BARDA as important as it has been portrayed? 22 Apr 2014 15:11 #1579

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The announcement of the BARDA contract was heralded as a great step for Cytori. It seems that as of late many in the "community" are playing down the significance of the deal. My feeling has been that if Cytori can leverage the deal with BARDA to fund the research to develop a cost effective portable celution generation machine; and if that machine and the cells it can provide can be shown to be an effective therapy for burns etc. . Then the deal could be a catlyst for exponential growth. I know. I know. Lots of if's

I would be interested in any comments from my raccoon brothers that are much more knowlegeable on Cytori's history, and science, I understand the fact that no one has a crystal ball, (you don't have one do you FAS?) Yet I find myself wondering if the development of ADRC's is imminent or if their therapeutic applications are many years away.

I sometimes become disalusioned by the ebb and flow of energy that is generated by Cytori. But I must admit I have learned a lot since joining this board.

Thank you fellow Racoons

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Is BARDA as important as it has been portrayed? 22 Apr 2014 15:42 #1581

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Maybe we could go for the FDA expedited device approval for burns. Hopefully this new law will help the new device get approved quicker.... Yes it would be nice to hear where we are at regarding the new table top cellution.

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Is BARDA as important as it has been portrayed? 23 Apr 2014 07:58 #1583

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Fatboy-

Thanks for the relevant post. I do understand your confusion or disillusion, but first, let me confess- I do not have a CRYSTAL BALL, but I do have an excellent memory and the conviction that:

Opportunities come and go. Achievements and know-how remain forever.

To start with my own conclusion- YES- the development of ADRC therapies IS imminent, but has nothing to do with BARDA.

If you mean development of ADRC therapies in the US- yes- than we are talking something completely different and you probably are right. BARDA will surely help move that along in a much more efficient manner than what Cytori can do themselves. (which happens to be very little)
Exponential growth is likely to be the result of that- but do not forget this is likely to be in 5-6 years after the clinics under the wings of CBER (FDA) are completed.

This is really not what I view as a "grand opportunity" since this is far far away in time. Other opportunities are there HERE AND NOW (assuming the gents in La Jolla did their job) and this is to me much more relevant.

What those things are - are all over the place on this page and I personally feel, I do not have to repeat those on the Board on a daily basis. :cry:
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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:

Is BARDA as important as it has been portrayed? 23 Apr 2014 09:54 #1585

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Thank you Fas. I am somewhat myopic concerning the state of cytori's progress here in the US. So I do depend on your expertise in the European and other international markets. I can understand your frustration with having to reiterate information that you know and that you have selflessly posted over many years. I think I can speak for everyone on this board when I say that your thoughts on cytori and regenerative medicine are held in the highest esteem by all of us.

I too am frustrated by the lack of execution by management. Or if there is something going on - the lack of communication of the progress being made. If as you seem to believe, there are opportunities globally that are not being pursued, then that is a serious flaw in the business plan. Things like that are what scare me. I have a significant investment in the company. An investment that I dream will someday catapult me out of this rat race. Every day wasted is one that I have to spend in the wasteland.

So I look here and other places to try to formulate a strategy that will keep me sane and hopefully make me some money.

Thanks for being the backbone of this board and for your work .
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Is BARDA as important as it has been portrayed? 23 Apr 2014 12:06 #1586

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Good post fatboy you sure have expressed sentiments of many. A serious flaw in the business plan is an understatement. A complete failure to execute or communicate, effectively , honestly , and to manage investor expectations gets a grade of F. Fas, do you continue to hold your position in Cytori or have you reduced. With the timeline you expect , based on info derived from numerous posts it seems you believe improvement is years off. That said Cytori does not have years ,nor sufficient dollars to invest to make this a reality for current shareholders. perhaps the pps will be manipulated to get those that hold May warrants to exercise but what about the ones that expire in I believe Sept? an Mangement has led us to believe they will be a source of a fair amount of much needed capital. I personally hold only shares which based on this pathetic pps are no more then options that don't expire until the company goes belly up, is sold, or actually delivers on it's promises.
This is sure a time bomb waiting to explode :bang:
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Is BARDA as important as it has been portrayed? 23 Apr 2014 12:48 #1587

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, based on info derived from numerous posts it seems you believe improvement is years off.


Michael-

Apparently you do not read very accurately. Just go back to my posts on "This is NOT the Company I know".

Those are the events I believe in- ASSUMING the Management of Cytori has done the work shareholders like myself expect them to do.
These are the only events and possible reasons why Dean´s 10XWD can be explained with. BARDA etc certainly not from the short term perspective.

I do believe the technology is disruptive making deals with BIG PHARMA unlikely- I do not rule out anything with device makers or governments though. On top of that- Japan is due shortly and Europe should be already, although I fear management made terrible mistakes there again- as always. :bang:

And by the way- I did add to my position from one year ago during the past 12 months.
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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:

Is BARDA as important as it has been portrayed? 23 Apr 2014 13:06 #1588

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fatboy,

IMHO, BARDA is a big deal on multiple fronts and here is how I see it:

1) It provides full financing for a Pilot clinical trial for treating burns. Based on clinical data we've seen, showing efficacy should be HIGHLY PROBABLE in burns and should lead to full funding for the final BARDA phase, a Pivotal trial and ultimate FDA approval, all at no cost to Cytori ( actually includes a small profit margin). Will this approval also be useful for other soft tissue effects? I believe this is Cytori's hope but either way any FDA approval of the Celution, for any indication, is a BIG DEAL to valuation.

2) Approval of the next phase could lead to immediate Government orders. Likely won't be a huge order since the idea is to develop a cheap desktop version but just getting any government orders early will be a plus.

3) The other part of the next phase of BARDA is full financing of the development costs, including FDA approval, of the next generation tabletop version of Celution. One of Cytori's many execution mistakes, IMHO, was spending company resources on the Celution One, a more sophisticated and MORE EXPENSIVE version of the Celution. This will rectify that mistake and dramatically change the economics for small plastic surgery and orthopedic practices. No longer any need to invest $100K to bring in a legitimate cell therapy into a medical practice.

5) Off Label Use - Once an FDA approved stem cell extraction machine is approved by the FDA (and let's not forget the important fact that both BARDA and the FDA report to the Department of Health and Human Services and cooperation should be VERY HIGH), any doctor can purchase the desktop version (or Cytori can give it away with a purchase of a minimum purchase of disposables) and use it for off label purposes. There are already a large number of stem cell clinics operating in the USA using inferior technology in violation of FDA regs of minimal manipulation and using an FDA approved device would free them from regulatory risk. Plastic Surgery and Orthopedics are the low hanging fruit here.

6) Legitimacy - winning on something like this will allow Cytori to regain some of the legitimacy that years of failed execution and unfulfilled promises have robbed from the company's technology platform and from shareholders.

Click here if you want a refresher on the BARDA deal: seekingalpha.com/article/909331-worth-the-wait-implications-of-cytori-therapeutics-106-million-barda-contract

WST
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Is BARDA as important as it has been portrayed? 23 Apr 2014 15:05 #1589

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Fas,
I went back and read that post. It is as I remembered . There surely are many catalysts out there that if they come to fruition would bear much fruit..( mucho dinero) The company you know is not the comapany portrayed by mangement as there is nary a mention of what you point out and are feeling positive about. Therin lies the problem. The majority of us do not pocess the understanding of the technology as you do, and I am not sure mangement does either. I know you must have had many conversations with Chris, Mark and others on all subjects included in that post of 9 positives. As you know more then we do, you therefore have evry reason to be that much more frustrated then us as our focus is near term BARDA. as the most immediate catalyst. I see that Wall Street was able to get back on the site and his post also focuses on BARDA. To that I say. We know what can happen if we hear positive news, but what if result is typical Cytori and we don't. Correctly you are focused on the technology which we all believe is the magic bullet and keeps us here. If only there was news of progress on any of the 9 points you have made. As always, Thank you for your insight it is appreciated by all.

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Is BARDA as important as it has been portrayed? 23 Apr 2014 15:36 #1590

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Since Hedrick talked up BARDA like it was a "done deal" on the last conference call I have been waiting for any news on the progress being made. I am concerned that any dissapointment at this juncture of the cycle could be disasterous. So I will hold on to my optimism and speculate that the BOD had a strategy regarding BARDA when they appointed Hedrick. The second quarter is here and we should find out something soon.

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Is BARDA as important as it has been portrayed? 23 Apr 2014 17:03 #1591

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Fatboy, Its not a done deal until its done. However, having met with Marc Hedrick in NY last month, all indications are that it will. Still not a sure thing. Marc has been meeting with the FDA periodically to discuss the thermal burn trial design as if approval will happen. However, the bottom line is no one, and I mean NO ONE, can say with 100% certainty that it is done until BARDA makes the formal announcement. If we hadn't been suckered so many times with unmet promises by CC, everyone would be less skeptical and more at ease. I give it about a 90% chance now of success and with each passing day I think the odds improve. I think that if it the answer was NO we'd KNOW sooner rather than later. If and when it happens, I'll look like this.... www.cytx-investor.com/media/kunena/emoticons/bp.gif
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Is BARDA as important as it has been portrayed? 24 Apr 2014 14:53 #1596

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Thanks WST,

I read your article again. Thank you for trying to simplify a complicated agreement. The dates are so nebulous that it is hard to get a handle on when anything is going to happen. That is why it is so frustrating not getting clear and concise updates from our management. Of course it may be that they are not being given information to pass to us. I just got the feeling that Hedrick knew more than he was willing to disclose. Then he did have to say something at the conference call. Listening to Calhoun say the same old and then seeing him bid bon voyage would have been perverse.

Things seem to be working in our favor now. Hopefully we will get something to move the share price. That is the point of this exercise.

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Is BARDA as important as it has been portrayed? 25 Apr 2014 04:57 #1597

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BARDA is important for a number of reasons.

I. It is being undertaken by CYTX itself so the data belongs to us.
2. Unlike in the European and Japanese translational trials we have a clear understanding of the way to market depending on the results .
3. The clinical animal model being used in the priliminary trial is quite complex. If there is also internal organ damage and it shows efficacy above and beyond just the burn wounds, then it will be a very powerful argument in favour of governments further funding Cytori. (Fukushima, Three Mile Island, Chernobyl etc.).
4. The funding of the desk top device is huge. This would normally be entirely born by CYTX.
5. A lot of the fixed cost structure that would normaly be covered by the company will be covered by the government.
6. It provides validation to US investors who are more introspective with regard data. The rest of the world doesn't matter as much to them. The US market is huge with the highest levels of reimbursement. Success in the US is paramount financially.
7. Method of action in this wound state (radiation induced), regular burns, diabetic wounds and autoimmune induced wounds will have a large overlap in terms of the healing paradigm. A successful BARDA trial with proof of safety and efficacy will be a major validation for the use of ADRC in a broad range of related indications.

While it is true that the immediate financial results that accrue from these trials (Pilot - Pivotal) may well take a few years lets not forget that there is potential for a large number of other positive catalysts (as per Fas' list). These will increase our visibility and create enthusiasm for the Celution device. European and/or Japanese approval WITH reimbursement for an indication using ADRC will provide huge validation. If it is in a wound indication everyone will be taking the BARDA trial into consideration when trying to value CYTX, whether they be analysts or BP CEOs. The SP can benefit geometrically without BARDA even being in pivotal trials.
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Is BARDA as important as it has been portrayed? 28 Apr 2014 07:08 #1606

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3. The clinical animal model being used in the priliminary trial is quite complex. If there is also internal organ damage and it shows efficacy above and beyond just the burn wounds, then it will be a very powerful argument in favour of governments further funding Cytori. (Fukushima, Three Mile Island, Chernobyl etc.).


Yes- this one could move a global interest in the technology, since it is probably a study which is unique of its kind to study the gastro-intestinal impact of radiation (the gastro-tract is always effected first of the internal system)
I am really disappointed that so far nothing happened in Japan, although we have the best contacts possible.

Just a reminder- Dr. Kiyoshi Kurokawa is Chairman of Cellsociety with the other members- Hedrick, Perin and Cohen. :whistle:


Kurokawa was honored by AAAS “for his contribution to society by his remarkable stewardship of an independent investigation into the causes of the Fukushima nuclear catastrophe” and “for his courage in challenging some of the most ingrained conventions of Japanese governance and society.”

His award-winning service followed the 11 March 2011 earthquake that triggered a devastating tsunami. The ensuing crisis included the full meltdown of three reactors at the Fukushima Nuclear Power Plant as well as several hydrogen-air chemical explosions and releases of radioactive materials into the atmosphere, AAAS noted. As public fears and confusion escalated, the Japanese Parliament appointed an independent commission, directed by Kurokawa, to investigate the causes of the accident.


Link to article: Kurokawa wins AAAS Award
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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:

Is BARDA as important as it has been portrayed? 28 Apr 2014 10:20 #1609

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***I am really disappointed that so far nothing happened in Japan, although we have the best contacts possible.***

No worries Fas, we still have CC til July 1st !!! :joy: :joy: :joy: :grin: :grin: :grin: :cry:

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Is BARDA as important as it has been portrayed? 10 May 2014 19:48 #1663

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Another reason that BARDA is important is that should the US government choose to proceed with funding of the Burn indication CYTX will eventually have to formally announce which other related products it will be utilising in the procedure.

I would imagine that some form of scaffold was used for the animal trials. It would only be natural that that scaffold is also used in the human trials, along with a fibroblast growth factor as was so clearly explained in Fas' .........

www.cytx-investor.com/plat-app/rad-wh.html#.U26-6CD6jIU

Could this be a catalyst for an announcement out of Japan .......... eventually...........

Surely any player in the wound care market who has an adjuvant product would want to secure the rights to the active cell component of the therapy!! Approved scaffold manufacturers may want to pay up some money to secure their products association with ADRC/Celution therapy thereby adding value to their existing investment . Deals may be national, regional or global. Surely there is some money to be earned from a positive BARDA decision. :yep:

This is not just about burns, it also has major applications in diabetic foot ulcers and chronic ulcers from PAD. :grin:

Fas, any ideas?

I have placed my bets (like Dean, I am a betting man). One day the ball will fall on our number .......... don't wait for the croupier to say ''rien ne va plus'' .......... it may be too late. :winky:
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Is BARDA as important as it has been portrayed? 11 May 2014 12:01 #1665

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Yes- potentially any manufacturer of a collagen scaffold or FGF spray could "partner" in the forth coming burns clinics, but the biomaterials require also separate approval to my knowledge.
Terudermis for instance is not approved in the EU yet, but will soon be.

My major attraction to BARDA is the leading role of the US in the world. Terrorist threat is not only a US problem but a global one.
The radiation consortium and the WHO (World Health Org) have been working for many years on this issue- CYTX tech could very well become the consensus technology for the Globe, if the US takes the first step.



From the Akita paper-

For treatment of systemic radiation injuries, stockpiled stem cells should be globally available through medical assistance network system under WHO-REMPAN, in which Nagasaki University is highly involved in its activity, or other international frameworks. Early resurfacing of the damaged skin and subcutaneous tissues is as important as hematological and intestinal system resuscitation Also, therapeutic guidelines for systemic radiation injuries are anticipated from practical and regulatory view points. Highlighting innovative technology and devices as well as currently existing medicines and devices is expected for the sake of preparing to treat “systemic” radiation injuries most effectively.


Stock piling of cells is not necessary as we know now, but the rest still pretty much applies.
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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:

Is BARDA as important as it has been portrayed? 13 May 2014 15:49 #1682

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Well wih that sad sad quarter reported yesterday the BARDA deal looms as a serious test for Cytori. It will move the company in a groundbreaking way either up or down. I am sure Hedrick realizes this. I am also sure he is doing all in his power to deliver a positive result. We are dealing with the US government however and the coffers are not bursting with cash at this time. Even a delay in the next stage of funding would be hard to overcome. More dilution at a lower PPS? I hope we can avoid that path. It is hard enough to stay positive these days.

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Is BARDA as important as it has been portrayed? 13 May 2014 16:30 #1683

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Fas
Yes Hedrick mentioned that the autologous aspect intrigued BARDA because the need to stockpile cells (drugs) had been an obstacle to creating a cost effective, streamlined response system. Obsolescence has been a problem in the past and Cytori's solutuion creates a more elegant treatment platform since the patient carries his own inventory of cells with him. Hopefully this is one more reason for BARDA to continue to fund the autologous fat cell model proposed by Cytori.

That and the prayers of the faithful! :yep:

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