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April 13 2016 is the date of the public hearing, which is of extreme importance for the future of Cytori as a Company. It will likely also determine whether Cytori is "partnerable" or not.
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TOPIC: FDA To Take Action?

FDA To Take Action? 16 Nov 2017 18:49 #10574

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US health agency to crack down on risky stem cell offerings.
http://abcnews.go.com/Health/wireStor-crack-risky-stem-cell-offerings-51200556
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FDA To Take Action? 16 Nov 2017 19:21 #10575

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LInk didn't work for me and I tried to post article in PDF but had problems as well.
Should work now -Fas
Anyway, just copy and paste:
US health agency to crack down on risky stem cell offerings.

in Google and you will see the PDF

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FDA To Take Action? 16 Nov 2017 19:28 #10576

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I wonder what Cytori would say about this part.

***The Food and Drug Administration laid out a
strategy for regulating cell-based medicine,
including hundreds of private clinics that have
opened across the nation in the last decade. Many
of the businesses promote stem cell injections for
dozens of diseases including arthritis, multiple
sclerosis and even Alzheimer's. They can cost
$5,000 to $50,000, but there's little research that
such procedures are safe or effective.***
***.***

I mean Cytori has now treated thousands of patients worldwide.
Now I guess you can read this as the mentioned disease processes only but it sounds like a more general tone to me...FDA still way out of touch !!!

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FDA To Take Action? 16 Nov 2017 20:56 #10577

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I wouldn’t classify the Mayo Clinic as a “risky clinic”.

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FDA To Take Action? 17 Nov 2017 05:09 #10578

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myownhedgefund wrote: I wonder what Cytori would say about this part.

***The Food and Drug Administration laid out a
strategy for regulating cell-based medicine,
including hundreds of private clinics that have
opened across the nation in the last decade. Many
of the businesses promote stem cell injections for
dozens of diseases including arthritis, multiple
sclerosis and even Alzheimer's. They can cost
$5,000 to $50,000, but there's little research that
such procedures are safe or effective.***
***.***

I mean Cytori has now treated thousands of patients worldwide.
Now I guess you can read this as the mentioned disease processes only but it sounds like a more general tone to me...FDA still way out of touch !!!


HF, this is great news for CYTX - are you aware of any clinic in the US where CYTX is intentionally using its stem cell therapy in violation of FDA guidelines??

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FDA To Take Action? 17 Nov 2017 05:16 #10579

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I also think that comes late, but the timing might help a bit in respect of the forthcoming FDA meeting. The FDA is a extremely slow moving "steamer" but at least it moves a bit.

From the recently linked statement of Gottlieb: (August)

In terms of compliance, and with regard to our increased oversight and enforcement: In the last few days alone, the FDA has taken steps in Florida and California to address a number of especially troubling products being marketed. But unfortunately, these are examples of a larger pool of actors who claim that their unproven and unsafe products will address a serious disease, but instead put patients at significant risk. We will seek to take additional actions in the coming months as we address this field, and target those who are clearly stepping over the line, at the same time that they create a potential danger to patients. We have examples where some of these unproven treatments have clearly harmed patients.
As the agency responsible for ensuring these therapies are safe and effective, I will not allow these activities to go unchecked. I’ve directed the FDA to launch a new working group to pursue unscrupulous clinics through whatever legally enforceable means are necessary to protect the public health. Late last week, FDA worked with the United States Attorney to ask a court to seize the components of a product that involved the use of vaccinia virus vaccine as part of a purported treatment for cancer that FDA believes created the potential for substantial risks to patients. The product posed significant public health concerns for the agency.
Ultimately, the agency’s goal is to make sure that the potential of regenerative medicine can continue to advance to benefit the patients who need new and innovative options for their medical problems. These technologies hold out the potential to significantly alter the course of a broad range of diseases. We are committed to taking steps to make sure these opportunities advance as quickly as possible. To do so, we must put in place the framework to separate the promising treatments from those products that pose significant risks or offer patients little to no chance of benefit. We will also continue to take steps to keep those who would exploit this promising area from harming patients and abusing the public’s trust. We can’t let a small number of unscrupulous actors poison the well for the good science that holds the promise of changing the contours of human illness and altering the trajectory of medicine and science.
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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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