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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 continues crack-down on Fat Cell Companies breaking the rules

FDA continues crack-down on Fat Cell Companies breaking the rules 07 Jan 2018 06:41 #10895

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On January 4th- Scott Gottlieb - the FDA commissioner- issued another FDA Press Announcement- this time in respect of a warning letter to Cryostem- it appears they mean business and that can only be good for Cytori- link- Here

This was the introduction:

FDA warns American CryoStem Corporation of significant deviations related to its unapproved stem cell product
Release
The U.S. Food and Drug Administration today posted a warning letter issued to American CryoStem Corporation of Monmouth Junction, New Jersey, and its Chairman/Chief Executive Officer, John S. Arnone, for marketing an adipose derived stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that raise potential significant safety concerns, putting patients at risk.
“As part of our comprehensive policy framework for the efficient development and regulation of cell-based regenerative medicine, we’re going to be stepping up enforcement activities against those who manufacture and market products in ways that put patients at risk,” said FDA Commissioner Scott Gottlieb, M.D. “We see great promise from the field of cell based regenerative medicine, but there are also novel risks. Our goal is to implement our new policy framework in a way that helps this promising field advance, while making sure that we address issues that can put patients at risk. It also means taking an efficient, risk-based approach to making sure that products undergoing more than minimal manipulation, which makes them subject to FDA’s review and approval, and particularly products intended to treat serious and/or life-threatening disease or conditions, must prove that they deliver the benefits they’re promising to patients.”

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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:

FDA continues crack-down on Fat Cell Companies breaking the rules 07 Jan 2018 08:22 #10896

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It is worth while to learn about the assessment of an insider in the SC industry like Chris Centeno, orthopedic surgeon and somebody who has gone through a long legal battle on regulatory battles with the FDA-

he wrote an article on this action, which is very worth while reading:


A while back I warned about a company called American CryoStem (ACS) and physicians who were holding a seminar on how fat cells could be collected and culture expanded. You see, this was clearly illegal, but the physician network (who put on the seminar) claimed it was all under an Institutional Review Board (IRB), so it was legal. Turns out I was right, as ACS just received a Warning Letter from the FDA. Let’s review the issues.


Continue reading: HERE

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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:

FDA continues crack-down on Fat Cell Companies breaking the rules 07 Jan 2018 10:10 #10897

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Agree, generally good for Cytori and the industry but Cytori still needs someone who can design trials that can show what they can do the FIRST time tested.
I wonder how this effects the old puregraft product if the FDA really starts enforcing ?

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FDA continues crack-down on Fat Cell Companies breaking the rules 07 Jan 2018 11:01 #10898

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myownhedgefund wrote: I wonder how this effects the old puregraft product if the FDA really starts enforcing ?


Puregraft is just purified fat, as the word implies, so is not a stem cell product as such. I do not think that would be affected in any way.

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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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