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TOPIC: Rendez-vous with FDA

Rendez-vous with FDA 21 Sep 2012 12:58 #11

  • fas
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The two lovers- Cytori and FDA meet in the court of appeals in D.C. today- September 21 2012. :woohoo:

Will the result be final divorce or re-newing the love for each other as evidenced by ATHENA?

We will know sooner or later

:evil:

Update- first report on the case-

Cytori Protests FDA's Cold Shoulder Toward Its Devices

By Erica Teichert

Law360, Washington (September 21, 2012, 3:39 PM ET) -- Cytori Therapeutics Inc. told a D.C. Circuit panel Friday the U.S. Food and Drug Administration had erred when it denied marketing approval for two Cytori medical devices and failed to consider alternative options that would have assuaged its concerns.

Cytori claims the FDA refused to grant 510(k) approval for two devices — Celution 700/LAB and StemSource 900/MB — that harvest stem cells from fat tissue over off-label marketing concerns, which it never consulted the company about.

Cytori's counsel Andrew S. Ittleman said labeling provisions, doctor notifications or discussions with the company about the worries could have cleared up any issues and still allowed the company to market the devices. But he claims the FDA never explained the problem or considered alternative remedies.

“They had an obligation to communicate with Cytori and request more information,” Ittleman told the panel. “They have an obligation to explore the gray area between the least and most Draconian remedies.”

But the D.C. Circuit panel noted the FDA is entitled to deference in its approval decisions, and Cytori faces an uphill battle to prove the rejection was arbitrary and capricious.

“How can we second-guess their determination in a case like this?” Judge Brett M. Kavanaugh asked. “Either way FDA went on a question like that seems to make sense.”

Ittleman maintained that giving the agency some deference doesn't give it a free pass out of judicial review, and alleged the FDA considered evidence in its decision that was prohibited under congressional statutes.

But after reading the statute, Judge David B. Sentelle told Ittleman he was expounding on the legislation to bolster his case.

“There's no language explicitly saying what not to look at,” Judge Sentelle said.

FDA counsel Adam Jed maintained the agency had looked at Cytori's own labeling and approval applications to make its decision. It determined the devices weren't substantially equivalent to other stem cell harvesting tools, which take stem cells from the blood rather than from fatty tissue, according to Jed.

Jed also said the company's premise is unsupported and relies on unsubstantiated factual assumptions. In particular, Cytori's applications hinge on the return of the stem cells to their donors, but the FDA has concerns it could be used for off-label therapeutic treatments for others.

Judges David B. Sentelle, Janice Rogers Brown and Brett M. Kavanaugh sat on the panel for the D.C. Circuit.

Cytori is represented by Mitchell Fuerst and Andrew S. Ittleman of Fuerst Ittleman PL.

The case is Cytori Therapeutics Inc. v. U.S. Food and Drug Administration, case number 11-1268, in the U.S. Court of Appeals for the District of Columbia Circuit.
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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:

Rendez-vous with FDA 23 Sep 2012 07:10 #12

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The article apparently ignited an avalanche of mails between investors, including Cytori IR. especially since certain posters at Yahoo appear to draw pre-mature conclusions. :sick:

Am sure Tom doesn't mind if I share his response, since its a comment on public statements and not an answer to a "private" question- I personally fully agree with Tom- have also read all court filings, but feel one has to be a seasoned lawyer to make any sense out of the case. And even that could be absolutely wrong- so there is no alternative but to wait until the courts judgment comes out. B)

Tom´s comment: No decision was made in the case and it's impossible to handicap at this
point. Whoever suggests we lost the case lacks knowledge of how this court
case works. The report below doesn't say anything nor does it particularly
represent what actually transpired. A decision could come later this year or
early next. We made our oral arguments and were asked some questions by the
panel, which is typical, and they made their oral argument, which started on
jurisdiction, which the court had already ruled on before orals and the
panel didn't want to get into again yesterday. They then made their merits
case and there were little if any questions coming from the panel.

Either way, the outcome of this decision has no impact on ATHENA. To drive
the kind of sales we all want/expect, we NEED approval from clinical trials,
such as ATHENA. 5-year follow up as mentioned below is not true. Whoever
wrote that doesn't know the cardiac space very well, so it's surprising they
would try to sound like an expert.


On the ATHENA comment- of course all end-points are either based on 6- and 12 months data on which basis the decision to go forward or approval etc will be based. The five year has only to do with MACE etc - every self-respecting cardiac trial wants to publish scientific papers in the future sometime evaluating these 5 year data to see to mortality impact/improvement at some point.

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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:

Rendez-vous with FDA 24 Sep 2012 07:44 #13

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Hallo Fas,
Gruß in die Südpfalz. Was genau bedeutet dies eigentlich für Cytori konkret?
Ich hoffe Du kannst mir hier weiterhelfen -habe keine Ahnung von amerikanischem Zulassungsrecht.
Ciao
Andreas

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Rendez-vous with FDA 24 Sep 2012 08:11 #14

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Hi Andreas-

For Cytori it means that they still have to wait 2-6 months for a judgment and no one knows how this judgment is going to look like after 2 short oral statements and some questions by the panel. So- at present the court case has no relevance for the short term and one can only guess. The whole topic is a waste of time, especially for those who do not understand the issues. :silly:
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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:

Rendez-vous with FDA 29 Sep 2012 03:33 #15

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Hi Fas,

Would you qualify the BARDA news as a Therapeutic Partnership in the mouth of CC? Or can we expect further news of real therapeutic partnerships in the very, very, very :-) ...near term?

Cheers,

Belgiumineurope

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Rendez-vous with FDA 13 Oct 2012 09:25 #19

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First- sorry for not responding earlier Belgium- I was in hospital for a few weeks- am briefly at home now, but will be gone next week for a month of rehab. :ohmy:
But to answer your question- yes- this qualifies very much so as a therapeutic partner deal. A very important one even. Besides reimbursement for development cost and receiving significant money upon achieving milestones- for me the key thing here is, that the "partner" is also the future customer. Therefore no marketing necessary, ramp up etc etc, but roll-out of new generation Celution AND CONSUMABLES for preparedness after proof of evidence and FDA approval.
Real big stuff, which I believe will be followed by other countries. And low risk of failure. :woohoo:

I listened to the webcast today and heard the usual nonsense from Hedrick, why this works. Believe me- although not mentioned in the webcast- Cytori has expanded CE claims on Celution for radiation wounds and thermal burns through translational clinics by some future partner (announced August 9). So plenty of clinical evidence, which BARDA certainly could have had a peek at. That the US picked the tech for preparedness for nuclear events is mind blowing- the rest of the globe surely will follow. :whistle:

Mind you- this is also just the beginning in respect of radiation too- as John Fraser mentioned whilst discussing the animal pre-clinic. BARDA would like animal data i.e. proof of concept, on the combination thermal burns and radiation injury - but Fraser indicated that it would be silly not to look at the impact at the animals of organs also.
THIS IS KEY!!! - burns and wounds are unlikely to kill folks after a nuclear incident and resulting ARS. (Acute Radiation Syndrom)- the resulting impact on particularly the gastro-intestinal tract DOES kill and here you want a therapy.
There are several articles on my page that explain the immune modulation and anti-inflammatory virtues of ADRCs, which make them the best medical solution for ARS and the business model fits perfectly i.e. no stockpiling of medicine, but of devices and consumables. :evil:

Cytori has taken its first step in becoming a multi-billion outfit and nobody realizes that except the happy few. Was nice to hear that Brian (Gagnon) appears to be back on board.

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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:

Rendez-vous with FDA 13 Oct 2012 09:47 #20

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Kaas, thanks for the answer. So hopefully a second partnership will follow shortly, and maybe even combined with some nice European news ....
I wish you all the best in the coming weeks !

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