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Adult Stem Cell News and Developments other than Cytori
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TOPIC: FDA Warns Stem Cell Clinic

FDA Warns Stem Cell Clinic 12 Jan 2016 13:41 #5997

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After many years of inaction, the FDA has finally gone after a stem cell clinic by issuing this letter . I think this is great news for Cytori, and certainly for Okyanos. I'm not saying it will have an immediate effect on the dismal valuation but the fact that an industry has developed illegally, with sub par technology, while Cytori invested hundreds of millions of our money always bugged me. Like I've always said the demand for the product is there and if the crackdown continues, these clinics will have no choice but to seek out Cytori if they can get to the FDA finish line in OA. Than the interesting question will become off label use, a problem I'd like to have.
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FDA Warns Stem Cell Clinic 13 Jan 2016 12:02 #6012

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Yes- this is excellent news and most likely a forebode of the public hearings coming in April (?) or so.

There are surely good reasons (from the public, patients and "rogue" doctors") coming why SVF should be a 361 tissue, but the FDA will ignore all that and democratically will decide on its course of argumentation which it has developed over the past 8 years or so. :grin:

Anyway- WST- I looked at LinkdIn Cell Therapy Industry Group expecting a heated discussion there, but did not find anything. Total silence (as in the past few years)

Where did you dig this up?

Thanks

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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 Warns Stem Cell Clinic 13 Jan 2016 12:10 #6013

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This is a link to warning letters issued by the FDA:

www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/default.htm

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FDA Warns Stem Cell Clinic 13 Jan 2016 12:34 #6014

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Wall Street Titan wrote: This is a link to warning letters issued by the FDA:

www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/default.htm


I see. Last "other" warning letter from CBER was on a PRP app in October. So- this is pretty much a "major event"

Sure- you do not want to post this at LinkedIn- Centeno will love you... :grin:

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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 Warns Stem Cell Clinic 13 Jan 2016 12:44 #6015

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Note sure what letter you are referring to but no, won't be posting it. What is the name of the company involved? I would like to see it.

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FDA Warns Stem Cell Clinic 13 Jan 2016 12:57 #6016

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Wall Street Titan wrote: Note sure what letter you are referring to but no, won't be posting it. What is the name of the company involved? I would like to see it.


I was simply sorting that information by issuing office and date, which told me that CBER "warning letters" are rare.

The last one before Irvine was this one - Eclipse CBER Warning Letter


Anyway- I have other things to do. Surely Alexey will pick it up... :yep:

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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 Warns Stem Cell Clinic 14 Jan 2016 06:40 #6020

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Paul Knoepfler acted first on Tuesday after picking up somebodies tweet...

Knoepfler on Warning Letter




He is going to interview CSN leadership- so stay tuned. :whistle:

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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 Warns Stem Cell Clinic 14 Jan 2016 10:19 #6023

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Nothing will happen until somebody dies. That's the way the system works! :yawn:

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