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TOPIC: Broad Scleroderma Orphan Drug Designation at EMA

Broad Scleroderma Orphan Drug Designation at EMA 10 May 2016 06:19 #6926

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May 10, 2016
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today that the European Commission has granted orphan drug status to a broad range of Cytori Cell Therapy® formulations when used for the treatment of hand dysfunction and Raynaud’s Phenomenon in patients with scleroderma.
Key benefits of this broad orphan drug designation include: (1) the ability to pursue multiple therapeutic formulations for systemic scleroderma that are not restricted to the processing of the adipose-derived cellular therapeutics at the bedside with the Celution® System or other current technology, (2) allows adipose-derived cellular therapeutics that are cryopreserved for later administration and (3) provides a pathway for Cytori to expeditiously seek conditional market approval in the EU.
“This broad orphan designation expands our strategic regulatory position and commercial options in Europe,” said Marc Hedrick, President and CEO of Cytori Therapeutics. “We intend to rely on this orphan designation, as well as long term safety and efficacy data from the SCLERADEC-I trial to seek conditional market authorization from the European Medicines Agency (EMA) on an accelerated timeline.”
“Orphan designation in Europe comes with significant benefits,” said Kenneth K. Kleinhenz, Vice President of Global Regulatory Affairs and Quality Assurance of Cytori Therapeutics. “These benefits include up to 10 years of market exclusivity if the medicine is authorized by the European Medicines Agency (EMA), access to the EMA’s conditional marketing authorization pathway (which is designed for orphan products that have initial clinical data and are actively in the process of completing their pivotal clinical studies), and an additional 10% reduction in regulatory fees beyond the reductions already afforded us because of our SME status. We believe the ECCS-50 therapy for scleroderma may benefit from these accelerated programs in Europe. This broad orphan designation will play a key role in our ability to fully access these programs.”
More information about the orphan drug designation process and the potential advantages of orphan designation within the European Union can be found at the EMA website.

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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:

Broad Scleroderma Orphan Drug Designation at EMA 10 May 2016 08:39 #6927

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While this is positive news, typical ploy to wait to announce on day of conference call. Marc will focus on this to draw attention away from just what a terrible year this has been. So, they will announce a reverse split, when this news should drive the pps. As I have said many times, if there is so much news like this right around the corner , go to the OTC, trade there until organic growth of the pps takes you to levels that earn the company the right to trade on NASDQ. Instead once again long term shareholders will be ( and this is what is so great about this MB)
FUCKED

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Broad Scleroderma Orphan Drug Designation at EMA 10 May 2016 11:42 #6928

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Most of us surely will remember that scleroderma already HAS orphan drug status -as Cytori previously announced on April 7 2015.

A key element was included in that announcement, which still applies today and ensures a speedy switch from the Managed Access Program to full fledged approval relatively "soon".

“A significant portion of the overall European cell therapy approval process has now been completed given our existing CE Mark on the Celution System”, stated Kenneth Kleinhenz, Vice President of Regulatory Affairs and Quality Assurance at Cytori Therapeutics. “All cell therapy products used in combination with a medical device require external review by a European notified body. The CE Mark certificate previously issued by our notified body, achieved this requirement and includes much of the required manufacturing requirements since the ECCS-50 drug product is manufactured exclusively with the Celution System at the point of care. This modular approach alleviates many of the regulatory uncertainties with the manufacturing aspects of the EMA approval process, leaving the clinical data as the remaining milestone required for market authorization.”
In addition, a range of development, regulatory, and financial incentives are offered in the EU for medicines that have been granted an orphan designation by the European Commission5:
A form of scientific advice called protocol assistance
Access to the centralized authorization procedure using a single application
Additional incentives for micro, small, and medium-sized enterprises including administrative and procedural assistance and fee reductions
10 years of market exclusivity once approved
Reduced fees for regulatory activities
Incentives in EU member states

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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:

Broad Scleroderma Orphan Drug Designation at EMA 10 May 2016 12:26 #6930

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I think the r/s announcement will come this coming Friday and it will become effective next monday.

I think thee will be more news releases this week onward.

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Broad Scleroderma Orphan Drug Designation at EMA 10 May 2016 12:52 #6931

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Fran, If you believe that there will be news releases from this time forward, then you must agree that R?S is not in our best interest. If the news happens then the PPS goes up. If we go to OTC , get the pps up over a buck, then we come back to NASDQ. R/S 's will not work here. It is bullshit that Institutions will jump in because of a phony pps above $3, if the story does not change.
:puke:

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