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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 site: CYTX obtains orphan drug designation for ECCS-50

FDA site: CYTX obtains orphan drug designation for ECCS-50 11 Nov 2016 07:57 #7995

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News flash on screen at TD Ameritrade.

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FDA site: CYTX obtains orphan drug designation for ECCS-50 11 Nov 2016 09:59 #7997

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franshei wrote: News flash on screen at TD Ameritrade.


With Hedrick being in Japan, they will probably issue an announcement on Monday.

This is what Hedrick said in the call:

So kick things off let’s discuss the pipeline. And then specifically let’s talk about the Scleroderma program. So recall back in Q2 that we completed enrollment in the STAR US Scleroderma approval trial. Next week at the American College of Rheumatology meeting in Washington D.C. we're going to be presenting some high level preliminary results from that trial.
Again that trial remains blinded, but the presentation will include details about the ease and acceptance of the procedure, it’s safety profile and reveal some of the baseline characteristics of the scleroderma patients treated and that will be presented in poster format and will be happy to make that available to you when it's published.
Also as a reminder the full 12-month data readout in STAR is still expected in mid-2017. Things are going well there in terms of data collection. On the last call I mentioned U.S. orphan status and we're still waiting for approval. We have some interaction with the FDA but nothing formal as of yet and we’ll update you as we get more information.

Source: Seeking Alpha Transcript - 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 site: CYTX obtains orphan drug designation for ECCS-50 11 Nov 2016 14:37 #7998

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The FDA Orphan Drug Status was granted/or designated on Nov. 9, 2016 (under Orphan Designation and Approval). It could take a few days before the formal letter's arrival.

People may not know that there is a 7 year exclusivity for sales and marketing, upon marketing approval.

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FDA site: CYTX obtains orphan drug designation for ECCS-50 11 Nov 2016 14:42 #7999

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Orphan drug status is very good news.

I was also happy to hear about the breast reconstruction application/trials being accepted in Japan. I am not sure how reimbursement will be worked out but it is a positive. Lets not forget that the trial was not a failure in Europe. The problem was the cumbersome and time consuming nature of the procedure that was not cost effective from the standpoint of socialized medicine. The procedure may very well be being utilized at this very moment but only for those who can pay for it themselves: as these individuals are too few, plastic surgeons are not going to provide it ........ maybe Japan will be different?

The various investigator trials are very important. That is how we got scleroderma. I would like to know what is going on with PAD. There had been some very good results in the past. I think that the scleroderma data along with the BARDA data provides great support for this (and related indications) going forward. The ability to have systemic and wound site application of ADRC is a powerful and unique selling point ....... possibly even therapeutic !!!!!!

We need approval for scleroderma as it then opens up a floodgate of applications in a huge range of indications. I am hopeful.

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FDA site: CYTX obtains orphan drug designation for ECCS-50 11 Nov 2016 15:47 #8000

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Such a approval a positive for any company but only carries so far until FDA approval and reimbursement can be obtained but in this case I don't think we should overlook the positive it provides to partnership discussions.
Especially if the USA is back on the table and a bit of a precedent for other hand dysfunction therapies.

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FDA site: CYTX obtains orphan drug designation for ECCS-50 12 Nov 2016 07:44 #8001

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The various investigator trials are very important. That is how we got scleroderma. I would like to know what is going on with PAD. There had been some very good results in the past. I think that the scleroderma data along with the BARDA data provides great support for this (and related indications) going forward. The ability to have systemic and wound site application of ADRC is a powerful and unique selling point ....... possibly even therapeutic !!!!!!

From the 10-Q

The future : We expect to continue to generate a majority of product revenues from the sale of Cytori Cell Therapy-related products to researchers, clinicians, and distributors in EMEA, Japan, Asia Pacific, and the Americas. In Japan and EMEA, researchers will use our technology in ongoing and new investigator-initiated and funded studies focused on, but not limited to, hand scleroderma, Crohn’s disease, peripheral artery disease, erectile dysfunction, and diabetic foot ulcers. ECCS-50 therapy for hand scleroderma will be accessible to patients and physicians through a managed access program, or MAP, that we initiated in EMEA in 2016. In the America’s, Cytori’s partner, Kerastem, is utilizing the Cytori Cell Therapy technology as part of its FDA-approved STYLE trial for patients with alopecia, or hair loss. Overall, we expect 2016 product revenues to remain relatively consistent with 2015.

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FDA site: CYTX obtains orphan drug designation for ECCS-50 12 Nov 2016 08:42 #8002

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Franshei,

I went looking for the FDA designation and could not verify Cytori's ECCS-50, but I did find this:
sclerodermanews.com/2016/07/14/20160714ibio-granted-fda-orphan-drug-designation-for-scleroderma-product-candidate/

Are you sure the FDA has granted Cytori orphan drug status? A contact of mine said the FDA site was confusing and thought they had said NO to Cytori. Any clarification/verification??

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FDA site: CYTX obtains orphan drug designation for ECCS-50 12 Nov 2016 09:17 #8003

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Oh boy....LOL
Explains Hedrick's comments better on the subject
Thanks DOV
The true tell will be if we hear something from the company next week.
Although franshei was alerted by a news flash, so ????

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FDA site: CYTX obtains orphan drug designation for ECCS-50 12 Nov 2016 09:25 #8004

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FDA site: CYTX obtains orphan drug designation for ECCS-50 12 Nov 2016 09:34 #8005

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Searched a couple more things because of the terminology on the previous link of designation vs approval and it seems to me it is one in the same and franshei is correct.
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Designating an Orphan Product: Drugs and Biological Products

The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (“drug”) to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphan status”). For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria specified in the ODA and FDA’s implementing regulations at 21 CFR Part 316. Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits for qualified clinical testing. A marketing application for a prescription drug product that has received orphan designation is not subject to a prescription drug user fee unless the application includes an indication for other than the rare disease or condition for which the drug was designated.
A sponsor seeking orphan designation for a drug must submit a request for designation to OOPD with the information required in 21 CFR 316.20 and 316.21. Each designation request must stand on its own merit. Sponsors requesting designation of the same drug for the same rare disease or condition as a previously designated product must submit their own data and information in support of their designation request. The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well-controlled studies.
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Again, official notice from Cytori should come next week if this is indeed the case

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FDA site: CYTX obtains orphan drug designation for ECCS-50 14 Nov 2016 07:26 #8011

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Hedgefund, thanks for the research on ECCS-50 - no release likely today since usually CYTX issues before 8:00 AM ET - I asked Tiago by e-mail on Friday why no release and I received no response (unlike him) - must be waiting for a "formal" letter, but that makes no sense to me if it's already public info???????

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FDA site: CYTX obtains orphan drug designation for ECCS-50 14 Nov 2016 11:15 #8016

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Release at 12:09 pm ET on orphan drug status!!:nice: :nice:

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