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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: Historic action by FDA and DOJ finally?

Historic action by FDA and DOJ finally? 10 May 2018 05:02 #11753

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Paul Knoepfler wrote a blog item yesterday on what appears to be action- FINALLY- against some of the major players in the ongoing wild west saga of Stem Cell Clinics advertising - as mtpinman recently also reported upon- FDA unapproved treatments with SVF against all kind of disorders.

The injunctions are against US Stem Cell i.e Kirstion Komella (formerly Bioheart) and Stem Surgical Network i.e. Berman and Lander.

From his article-

“A permanent injunction is being sought against US Stem Cell Clinic LLC of Sunrise, Florida, its Chief Scientific Officer Kristin Comella and its co-owner and managing officer Theodore Gradel for marketing to patients stem cell products without FDA approval and while violating current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk. The FDA is taking this action because US Stem Cell Clinic did not address the violations outlined in a warning letter to the clinic and failed to come into compliance with the law. The FDA is seeking an order of permanent injunction requiring US Stem Cell and the individual defendants to cease marketing their stem cell products until, among other things, they obtain necessary FDA approvals and correct their violations of current good manufacturing practice requirements.

The FDA is also seeking a permanent injunction to stop California Stem Cell Treatment Center Inc., with locations in Rancho Mirage and Beverly Hills, California; Cell Surgical Network Corporation of Rancho Mirage, California; and Elliot B. Lander, M.D. and Mark Berman, M.D., from marketing to patients stem cell products without FDA approval. Berman and Lander control the operations of approximately 100 for-profit affiliate clinics, including the California Stem Cell Treatment Center. The FDA is seeking an order of permanent injunction requiring California Stem Cell Treatment Center Inc. and Cell Surgical Network Corporation and the individual defendants to cease marketing their stem cell products until, among other things, they obtain necessary FDA approvals and correct their violations of current good manufacturing practice requirements.”


Link to article : HERE
The following user(s) said Thank You: mtpinman

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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:

Historic action by FDA and DOJ finally? 10 May 2018 05:17 #11754

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I do think, this is extremely important news for Cytori too.

To me, CYTX CCP was never really partnerable in the US, when cheap (but inferior treatments most likely) were competing in the market against any procedure cytori had developed. Copy-cats without the expense of FDA approval have a huge competitive advantage of course

Please Log in or Create an account to join the conversation.

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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