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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: More regulatory delays by FDA re fat stem cells

More regulatory delays by FDA re fat stem cells 01 Mar 2016 13:03 #6513

  • joeycav11
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I signed up for the meeting and got this today.



There has been considerable interest in the Public Hearing, “Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products,” scheduled to take place on April 13, 2016. Due to this interest, and to give stakeholders additional time to provide comments to the agency, FDA intends to extend the comment period for the draft guidance documents, and has postponed the hearing, which will be rescheduled later this year at a date to be determined. The agency also intends to schedule a scientific workshop to gather information from manufacturers of cell based products, clinical researchers, and other stakeholders regarding the generation of scientific evidence to facilitate the development of safe and effective cell based therapeutics.



Information on the rescheduled hearing, including date, location and registration information, will be made available on FDA’s website and will be published in the Federal Register. We will announce the dates for the hearing and the workshop in the near future.



FDA’s announcement will contain information on how stakeholders interested in speaking, including those who were scheduled to speak at the hearing on April 13th, can sign up to speak at the rescheduled hearing.



Thank you

Food and Drug Administration

Center for Biologics Evaluation and Research
The following user(s) said Thank You: myownhedgefund

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More regulatory delays by FDA re fat stem cells 01 Mar 2016 13:18 #6514

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Personally, I am convinced little has changed at the FDA with regard to this type of therapy.

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More regulatory delays by FDA re fat stem cells 03 Mar 2016 05:40 #6528

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Thanks Joey-

I agree with Hedge that in end effect this will not change anything from a legislative perspective.

From an organizational perspective they HAD to do something since 3 minutes speaking time per scheduled speaker (as seen in the draft agenda) is just enough-on average- for the speaker to walk to the podium, get back to his seat and maybe say in between those actions- hello I am Mr./Mss XXXX. Than time would be up.. :whistle:

Congrats with your investment in MESO- they have really taken off :KO: :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:

More regulatory delays by FDA re fat stem cells 22 Apr 2016 13:51 #6857

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The FDA hearing regarding fat stem cells has been rescheduled to a 2 day hearing in September. US Stem Cell (formerly Bioheart), which has a market cap of $250K but debts of $5,000,000, sent out an email to customers to try and get some support to stop the draft guidance and allow SVF to be part of the practice of medicine. Good idea for them because they have an interest in a clinic that is actively treating patients - making them a competitor to Okyanos in Florida. The end result of this rule will obviously have dramatic implications as will any legislation changes by the REGROW Act. A few years ago had Cytori won its ill advised lawsuit against the FDA this might have been a positive. However, now it may well be a negative to legalize the Wild Wild West of SFV. I would hope that a 501k approval would be needed as a minimum for any equipment used with minimum criteria for purity, output and consistency. All they would need to do is eliminate the predicate device hurdle that stopped Cytori dead in its tracks.

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More regulatory delays by FDA re fat stem cells 23 Apr 2016 10:17 #6863

  • CalhounDoppelganger
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Stem cells are a four letter wit to big pharma.

We need to just sell a drug and find the loophole.

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