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TOPIC: Incoming ATHENA data BURNING QUESTIONS!

Incoming ATHENA data BURNING QUESTIONS! 13 Mar 2015 13:53 #3781

  • agamemnus
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We know 100% that the RAW ATHENA numbers are incoming within the next two months, if not this month.

What I don't understand is this: (2 issues)

Things:
1) At first, I read that Cytori would disclose safety, feasibility, and efficacy.
2) Then I read in another Cytori release somewhere that they would release safety and feasibility, with no mention of efficacy.

Questions:
1) Which is right? Am I mis-reading something?
2) If they are only releasing safety and feasibility, what will this show? Safety -- we know it's safe. No points there. Feasibility -- as in, how many drop out mid-procedure or something?

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Incoming ATHENA data BURNING QUESTIONS! 13 Mar 2015 14:29 #3782

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Aga-

Ask yourself what "feasibility" means.

To me it means that the therapy is feasible and a therapy can only be feasible when it shows "signs of efficacy in a trial with low "n", which might not be statistically significant but looks very promising versus efficacy with a large "n", where the requirement to show efficacy is there meaning it has to be "statistically significant" at the same time.

Hedrick opted NOT to show the "feasibility data" of ADVANCE, which I thought was very disappointing. I conclude from that that the acute treatment does not work well and is the reason why private investigators have not picked up the therapy in Europe, contrary to expectations expressed by Cytori in the past. Since this is totally against theory, I am dying to know what the cause/reason is. Knowing Hedrick I probably will be dead by the time this is public knowledge. :cry:

Anyway- I think the chance that "feasibility data" are better with ATHENA make me optimistic we will get to know these "signs of efficacy" and some might even be statistically significant. :grin:

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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:

Incoming ATHENA data BURNING QUESTIONS! 13 Mar 2015 14:50 #3783

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I see. I think that makes sense, but it's still murky to me.

If results are not statistically significant, the results are only useful to move the stock price -- see OREX last week.

You can have different levels of confidence. At 34 or something patients, if the data is fine-grained enough and differences are big "enough", we will be able to clearly see whether it worked or not. The less of a difference between the three groups, and the less fine-grained the data, the less we can confidently say whether the trials were a success.

But, as you say, with a low amount of data points (n) and without encouraging and/or very statistically significant results, you cannot say that the therapy doesn't work, so you cannot disprove the null hypothesis. That's the up-shot to having a small sample size! If that happens though, it might be the reverse of the OREX thing and more similar to what we saw with CUR.

Most people (and retail investors... and sometimes institutional investors) don't know very much about statistics. (I hope I am not making any ironic statements here as my last statistics class was not too recent.)

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Incoming ATHENA data BURNING QUESTIONS! 16 Mar 2015 10:47 #3807

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Aggy

"The ATHENA clinical trial is designed to study the use of a patient’s own Adipose-Derived Regenerative Cells (ADRCs) to treat chronic heart failure from coronary heart disease in patients who are on maximal therapy and still have heart failure symptoms."

I think Hedrick understands that proving efficacy in a population of individuals who have run the gamut of therapies including drugs and surgeries is a daunting task. The halting of the trial was proof of the difficulty of working with patients who are at this state of coronary failure. Improving the quality of life when life itself is in such jeopardy is an elusive goal. Hopefully Okaynos will make positive impacts using this therapy and help move the science forward.

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Incoming ATHENA data BURNING QUESTIONS! 16 Mar 2015 20:38 #3817

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fatboy wrote: The halting of the trial was proof of the difficulty of working with patients who are at this state of coronary failure.


I was under the impression that they halted the trial because of funding concerns and the need (again, financially) to get published results in sooner rather than later -- they didn't know the full results at the time they decided to end the trial. But of course, difficulty = cost as well...

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Incoming ATHENA data BURNING QUESTIONS! 17 Mar 2015 09:11 #3821

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Some patients ( as I remember -2) had stroke like symptoms that were later resolved.

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Incoming ATHENA data BURNING QUESTIONS! 17 Mar 2015 10:50 #3828

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Yeah- there were 3 of which 2 cases resolved within hours- one took several days.



That reminds me of these amazing 60 minutes video´s I have watched a while ago, on living beyond 90. The elderly in a retirement home are being investigated and some of them had many- not to say heaps signs of small strokes in their brain (as discovered since they donated their brain after their death) which apparently never bothered these folks.... :vegas: :vegas:

Worth watching and be amazed :cool:

Link: Living to 90 and beyond
The following user(s) said Thank You: fatboy

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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:

Incoming ATHENA data BURNING QUESTIONS! 17 Mar 2015 17:35 #3837

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fatboy wrote: Some patients ( as I remember -2) had stroke like symptoms that were later resolved.


Yes, but I was referring to the decision to end the trials after Cytori had gotten approval from the FDA to resume them.

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Incoming ATHENA data BURNING QUESTIONS! 19 Mar 2015 12:25 #3860

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On Monday I will have my blood examined and I selected heaps of markers to get the right picture, including Vitamin B-1-6-12 and D & H levels. :write:

Matt already explained to me a while ago how important for instance Vitamin D is- a publication in ScienceDaily on the relationship of STROKE and vitamin D reinforced this all again..

Stroke patients with low vitamin D levels were found to be more likely than those with normal vitamin D levels to suffer severe strokes and have poor health months after stroke, according to research presented at the American Stroke Association's International Stroke Conference 2015.
Low vitamin D has been associated in past studies with neurovascular injury (damage to the major blood vessels supplying the brain, brainstem, and upper spinal cord).
"Many of the people we consider at high risk for developing stroke have low vitamin D levels. Understanding the link between stroke severity and vitamin D status will help us determine if we should treat vitamin D deficiency in these high-risk patients," said Nils Henninger, M.D., senior study author and assistant professor of neurology and psychiatry at University of Massachusetts Medical School in Worchester.
Henninger and colleagues studied whether low blood levels of 25-hydroxyvitamin D, a marker of vitamin D status, is predictive of ischemic stroke severity and poor health after stroke in 96 stroke patients treated between January 2013 and January 2014 at a U.S. hospital.
They found:


continue reading at : Science Daily Article

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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:

Incoming ATHENA data BURNING QUESTIONS! 03 Apr 2015 01:33 #4050

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So, it looks like they are late, or are they? I don't remember when Q1 ends for Cytori.

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Incoming ATHENA data BURNING QUESTIONS! 03 Apr 2015 10:58 #4052

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Aga-

The "normal" procedure is that the CRO´s analyse and compile data, which are than presented by the investigators at some session.

Apparently Hedrick "is taking this in-house" too - so do not expect anything soon.

I have been looking around for a suitable event, but really cannot find anything. One would expect something from the cardiac interventionalists - TCT or related organisation- to be most fitting. Nothing forthcoming really that fits. So- maybe they work on "putting cardiac on the backburner" and waiting for the Scientic Sessions in November... :grin: :bash:

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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:

Incoming ATHENA data BURNING QUESTIONS! 03 Apr 2015 11:54 #4054

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Sad...but par for the course. :cry:

One has to wonder what the Chinese think about it all ? :evil:

K T Lim still waiting in the wings. Limited cardiac data, still waiting for China.

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Incoming ATHENA data BURNING QUESTIONS! 03 Apr 2015 14:27 #4056

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Fas, I still don't agree with you about this. I thought that the presentation last month made it clear that raw data will be made available for investors. But we'll see, I guess...

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Incoming ATHENA data BURNING QUESTIONS! 03 Apr 2015 15:01 #4058

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aga

Do you think it will matter much when the data does get released....if it ever gets released.

Just another small sample. W/O a partner...it wont go anywhere for years.

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