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TOPIC: Cytori looses appeal

Cytori looses appeal 22 Mar 2013 10:09 #323

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Cytori looses appeal 22 Mar 2013 12:59 #324

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Yeah correct. (I just noticed, since I hardly follow the hour-to-hour stock patterns these days any longer)
This is what the market and Calhoun himself were expecting- question of course is, why spend the money to bring it to court, if that is what you believe.
Just we would probably have had a nice jump if it- beyond expectations, would have gone the other way.

Judge Brett Kavanaugh wrote for a three-judge panel that the appeals court must be careful when questioning the scientific judgment of an agency such as the FDA.

"FDA concluded and explained that fat is not blood and that the difference matters. A court is ill-equipped to second-guess that kind of agency scientific judgment," Kavanaugh wrote.


This statement is quite interesting: in the 231 court case the judge really "jumped on the seat of the "scientist" i.e. claiming the MSC´s in fat must be similar to bone marrow MSC´s since they looked alike

must have traveled from the marrow to the fat

Now we know that is rubbish and the cells behave similarly, but are distinct different species.

Here we have a judge, who avoids- or better refuses going into or digging into the fact, whether there is a RISK difference between extracting cells from bone marrow versus fat. Shows you -justice is unpredictable except when the parties have "unequal weight" :cool:
Very interesting indeed and makes the patents of Cytori worth more at the same time.

Mind you- just to refresh your memory- we know from Leeza (and others) that cells extracted MANUALLY from fat means you are making a DRUG and Cytori is still a DEVICE Company, but unfortunately will not be able to sell Celutions in the US to the "practice of Medicine" for the time being. BARDA will change that though, so we are moving to a MONOPOLY position- but it simply will take longer. :yawn:
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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:

Cytori looses appeal 22 Mar 2013 13:43 #325

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Found this release by Cytori just in my mailbox- this is concise and clear- ok guys.

Cytori Provides Update in 510(k) Appeal Decision

SAN DIEGO -- Cytori Therapeutics (NASDAQ: CYTX) today announced that the United States Court of Appeals for the District of Columbia Circuit has ruled on the Company's conjoined appeals (case no. 11-1268).

The court upheld the FDA's (Food and Drug Administration) previous determination that Cytori's cell processing devices were not substantially equivalent to the cited predicate devices. Cytori will continue to pursue its intended pathway to regulatory approval via the PMA (Premarket Approval) route, such as the active ATHENA clinical trial for refractory heart failure. Cytori received IDE (Investigational Device Exemption) in January 2012 required to initiate the ATHENA clinical trial.

This decision reaffirms our primary regulatory pathway in the U.S.," said Christopher J. Calhoun, Chief Executive Officer of Cytori. "Our priority remains unchanged, which is completion of clinical development of our Celution® System in refractory heart failure under the FDA's PMA clinical trial-based pathway for class 3 medical devices. Such a pathway provides the necessary data for approval, adoption, and reimbursement and will raise an additional barrier-to-entry for potential competitors who would be required to pursue the same PMA pathway. As a result, this decision further clarifies the standard-of-evidence required for the field."

Cytori has been pursuing parallel pathways to market. One pathway has been to obtain therapeutic indications, such as those being pursued in our cardiac development. The other pathway has been to obtain clearance for laboratory equipment that would provide technology access to researchers, for which Cytori has achieved approval in Europe and Japan. Cytori appealed the decision based on a series of prior 510(k) clearances and a 2009 determination by the FDA, through a formal request for designation by the office of FDA's combination products, that Cytori's cell processing technology would be regulated as a medical device and not a biologic. The appeal was related to the subsequent 2011 decision by the FDA to deny the 510(k) clearance for laboratory versions of our cell processing technology.

Regulatory Overview

The FDA regulates medical devices as class 1, 2, or 3. Typically, class 2 devices require a demonstration of substantial equivalence to a pre-existing device with limited or no clinical data. Class 3 devices are considered novel and more complex, thus require clinical data and/or clinical testing under the PMA pathway.

Cytori and the FDA agree that marketing approval for the Company's Celution® System for use in cardiovascular disease and other therapeutic indications requires a PMA. The appeals rulings announced today relate to the Company's separate actions to seek approval for tissue processing systems for use in banking and research as class 2 medical devices.
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Cytori looses appeal 22 Mar 2013 15:30 #326

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Fas, I like the "moving to monopoly" comment. The PMA route is now the way forward and with our patents in place this looks like suicide for the adipose oriented copycats.

Normally when a new drug is tested it is compared to placebo which is in fact the standard of care. Hopefully we become that standard of care soon/quickly. This decision raises the bar for copycats and competitors, vis a vis the Celution standard of care.

As for wasting money in the legal struggle to get 510(k) approval, does anyone doubt that that approach worked in Europe & Japan ....... NO!!!. To not have attempted the appeal would have been wrong. Admitedly it was not successful, but not because there was no basis for the appeal, but because judges did not feel they had the requisite expertise to second guess the FDA: "A court is ill-equipped to second-guess that kind of agency scientific judgment," Kavanaugh wrote. ........... unfortunate, but it is what it is.
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Cytori looses appeal 23 Mar 2013 15:29 #327

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As for wasting money in the legal struggle to get 510(k) approval, does anyone doubt that that approach worked in Europe & Japan ....... NO!!!. To not have attempted the appeal would have been wrong. Admittedly it was not successful, but not because there was no basis for the appeal, but because judges did not feel they had the requisite expertise to second guess the FDA: "A court is ill-equipped to second-guess that kind of agency scientific judgment," Kavanaugh wrote. ........... unfortunate, but it is what it is.


John- you are probably right.
Heaps of things cross my mind, when I go back in the past with the "modular" 510K approvals of the Celution device back in 2006/7.

We had all relevant 510K approvals besides the "combined" one, but the FDA changed the rules of the game with the introduction of some legislation changes (the infamous word change from- into "another" body to- into "a" body") and foundation of CBER.



I will put my article on this whole issue back on this site also, just for the sake of documenting these events. cardiac patients would be a lot better off, if Cytori would have been "6 months faster with its filings" so to speak.
Anyway- YES YES YES- what worked in Europe and in Japan is good enough too and the regulatory guys there are no dummies or crooks. They follow the rules that has been made by legislators based on the risk exposure to the patient population. Protecting patients lives,safety and health are the ultimate objectives, together with speed of applying innovation.
That does not work in the US- I do know from CC, what he really wanted is have universities pick up translational work and clinics just as happened in Europe and Japan- NOT to have shady clinics and doctors "abusing the practice of medicine" rules.



Having a hawkeye look at the scene in Europe- I know that is not happening here, so there must be a mentality difference between the US and Europe in this respect that the FDA "fears".

The ultimate result being- clinical investigation done in Europe and Japan- will be used in the US for evidence of safety and efficacy and going straight into PMA pivotals by "specific therapeutic indication".

Thats fine too -but progress as always has been delayed significantly. :cry:
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The following user(s) said Thank You: rongside

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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:
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