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TOPIC: 351 masquerading as a 361 -- MiMedix

351 masquerading as a 361 -- MiMedix 08 Sep 2013 17:26 #843

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Fas - good call on the FDA issues facing Osiris' Grafix product. They appear to have company, MiMedix.

phx.corporate-ir.net/phoenix.zhtml?c=213465&p=irol-newsArticle&ID=1852029&highlight=

As the old saying goes ..... you can't fight city hall .......... a lesson I believe CYTX has learned!

Bad luck, or probably criminal negligence on the part of MiMedix management ..........

No matter, one less competitor in the wound healing space. :happy: :woohoo: :joy: :vegas:
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351 masquerading as a 361 -- MiMedix 09 Sep 2013 06:21 #846

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Yes John- it is most likely the management of Osiris will receive a similar letter-
this is what I wrote on the subject at LinkedIn a few weeks back-

I meant to leave Grafix alone, but the recent developments at the FDA with CBER assuming responsibility for products containing living cells formerly having achieved PMA market approval by the device arm of the FDA- the CDRH- brought back my interest, since I do consider myself a bit of a global device regulation expert to the tune of " a one eye in the land of the blinds"- so there we go- Centeno telegramm style.
1. 21 CFR Part 1271 HCT/P regulations contain a bunch of lines, which have been interpreted by industry participants in many different ways. The few interpretations by the FDA themselves have been surprisingly conservative and if documented can be found at the Tissue Reference Group www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/RegulationofTissues/ucm152857.htm , which also describes "Grafix" as Chris already stated and concludes it is a 351 product i.e. a drug.
2.There is no mandatory rule issued by CBER that forces clinicians or commercial entities to consult CBER on interpretations of a product or procedure being a 351 or 361 product, before the product/procedure is brought to the market. This is a major flaw and should be corrected.
3. IMO corporate conduct and business governance and prudence should "force" a listed corporation to do actually that- verify own interpretation with the regulatory authority in order to indemnify shareholders for major negative surprises i.e. risk aversion should take prevalence over hype and "backdoor approaches" otherwise the Corporation will clearly be classified near the "scam corner"- not only by serious investors, but also by Big Pharma, who are used to dealing with the FDA in their businesses.
4. To me the recent announcement of the FDA to move wound care products containing living cells from the device arm CDRH to CBER on August 14 is no coincidence. Its simple- DermaGraft, ApliGraft, Orcell, Epicell are all brothers and sisters of Grafix- a tissue matrix with biological living cells added to the matrix for the main therapeutic mechanism of action- all allogeneic, which means that all products are dependent upon the metabolic activity of the living cells for its primary function and since they are not for autologous or for allogeneic use in a first-degree or second-degree relative- basically are all drugs.
5. Big question is- Osiris certainly was aware of the regulatory pathway for those similar products (Dermagraft etc), which was Class III device, requiring PMA clinical evidence BEFORE market authorization- why did they decide to challenge the FDA and assumed a 361 classification and marketing BEFORE clinical evidence? I think this is like trying to teach a big mean grizzly bear to dance in a circus. There comes a time that the grizzly is fed up being pulled around the nose and starts hitting back.


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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:

351 masquerading as a 361 -- MiMedix 21 Oct 2013 16:56 #997

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The cool facts right now is the FDA letter to Osiris- its rather clear....

C. Randall Mills, PhD
Chief Executive Officer
Osiris Therapeutics, Inc.
7015 Albert Einstein Drive
Columbia, MD 21046-1707

Dear Dr. Mills:

During an inspection of your firm, Osiris Therapeutics, Inc., located at 7015 Albert Einstein Drive, Columbia, MD, from May 23 to June 4, 2013, investigators from the Food and Drug Administration (FDA) collected information on the manufacture of a number of products that are derived from amniotic and chorionic tissue (amniotic/chorionic-based products). This information was provided to the FDA’s Center for Biologics Evaluation and Research (CBER) for review.

You are currently registered with the FDA to screen, test, package, process, store, label, and distribute a variety of amniotic/chorionic-based products. These products include: Ovation®,Grafix PRIME®, Grafix CORE®, and Grafix XC™, all of which are intended for use, among other things, in the repair, replacement, or reconstruction of tissue defects, as well as wound healing and tissue repair. These amniotic/chorionic-based products are human cells, tissues, and cellular and tissue-based products (HCT/Ps) as defined in 21 CFR 1271.3(d). However, these products are HCT/Ps that do not meet all of the criteria in 21 CFR 1271.10(a) and therefore, are not regulated solely under section 361 of the Public Health Service Act (PHS Act) and the regulations in 21 CFR Part 1271.

Your Ovation® product does not meet the minimal manipulation criterion set forth in 21 CFR 1271.3(f)(1) because your manufacturing process alters the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement. The original relevant characteristics of the structural tissue are altered significantly by the processing, which includes


(b)(4)
of the chorionic membrane,
(b)(4)
.

In addition, Ovation® and your products, Grafix PRIME®, Grafix CORE®, and Grafix XC™, do not meet the criterion in 21 CFR 1271.10(a)(4)(ii) because the products are dependent upon the metabolic activity of living cells for their primary function, and are not intended for autologous use or allogeneic use in a first or second degree relative.

The HCT/Ps referenced above are drugs as defined under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)] and biological products as defined in section 351(i) of the PHS Act [42 U.S.C. 262(i)].

Please be advised that in order to lawfully market a drug that is also a biological product, a valid biologics license must be in effect [42 U.S.C. 262(a)]. Such licenses are issued only after a showing of safety and efficacy for the product's intended use. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug (IND) application in effect as specified by FDA regulations [21 U.S.C. 355(i); 42 U.S.C. 262(a)(3); 21 CFR Part 312]. None of the amniotic/chorionic-based products described in this letter are the subject of an approved biologics license application (BLA), nor are there INDs in effect for any of these products. Based on this information, we have determined that your actions have violated the Act and the PHS Act.

This letter is not intended to be an all-inclusive review of the products that your firm markets. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and the PHS Act and their implementing regulations.

We request that you notify this office, in writing, of the steps you have taken or will take to address the violations noted above and to prevent their recurrence. Your response should be sent to me at the following address: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Suite 200 N, Rockville, Maryland 20852-1448.

If you have any questions regarding this matter, you may contact Anna M. Flynn at (301) 827-6201. Please be advised that only written communications are considered official.

Sincerely,

/s/

Mary A. Malarkey
Director

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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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