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TOPIC: UK early access to medicines was just launched

UK early access to medicines was just launched 07 Apr 2014 08:46 #1523

  • joeycav11
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Maybe good for fistulae and wound healing. I wonder if this pathway could be used to treat the heart with adipose stem cells

www.mhra.gov.uk/Howweregulate/Innovation/EarlieraccesstomedicinesschemeEAMS/index.htm
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UK early access to medicines was just launched 07 Apr 2014 13:06 #1525

  • rongside
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Nice find. Looks to be a similar type of regulation to that initiated in Japan....... fast track........ or USA Breakthrough process.

I looked at some of the links and it appears that it is geared more towards medicines. We already have european CE approval for the Celution device in a wide number of indications. I am not sure whether there is any material benefit for CYTX in those indications for which it already has CE approval.

What would be interesting is if the already existing data (which is not necessarily ours), that got those CE approvals can be used to get a positive designation, as per the legislation:

" ..... a scientific opinion is issued based on the benefit risk profile of the medicine. Positive scientific opinions will be made available on the MHRA’s website to assist doctors and patients in making treatment decisions, and inform them of the risks and benefits of the product."

If it helps our going through the NICE process with a favourable cost/benefit analysis then it would be most beneficial. Reimbursement is still the issue. Crohn's fistula and Scleroderma may be quick candidates as there is no existing treatment. ATHENA data could provide a strong case in the near future ......... not sure PRECISE data is sufficient.

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UK early access to medicines was just launched 09 Apr 2014 06:51 #1526

  • fas
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It does look a lot like the compassionate use programs that I read a few years back for Italy for instance..

Although medicine approval is now (since 2007) centralized in the EMA (European Medicine Agency) in Europe (devices still by country and NOT centralized), the last also seem to apply to compassionate use programs and early access to "new medicine" or "new therapies" for that matter.

This is all really nicely done in Germany and now also in the UK.

The opportunities are there to make use of these programs- Cytori apparently is incapable to do so. :bang:

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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:

UK early access to medicines was just launched 09 Apr 2014 11:32 #1527

  • rothco619
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Fas, and therein lies the problem. All the hoopla about breast reconstruction in Europe years ago and what do we have to show for it ?
Nil, nada ,zilch zero, bupkus. If it's incompetance then what has changed replacing CC with Hendrik. Are we insane to expect a differnt result? :puke: :bash:

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UK early access to medicines was just launched 09 Apr 2014 12:01 #1528

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If it's incompetance then what has changed replacing CC with Hendrik. Are we insane to expect a differnt result?


To be perfectly honest- I hardly expect different results from Hedrick, but than again- with or without CC- the long awaited Japan change and opportunities are just around the corner.

Could be that with CC gone now- some very valuable former employees who left because of certain reasons, might return and right the ship in Europe too??? :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:

UK early access to medicines was just launched 09 Apr 2014 13:13 #1529

  • myownhedgefund
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Someone to develope what we have approval in Europe would be a huge positive as we wait for ATHENA trials to run their course...too bad we already have a marketing VP that, at least on the surface, hasnt developed this market at all and we are left with is the faint hope of new or perhaps in the case you refer to Fas, old blood, returning to get this moving. Kind of pathetic imho.

Should we even speculate that CC is trying to accomplish something in his new almost 90 day position ? Do we really even want such a possibility given the history ?

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UK early access to medicines was just launched 09 Apr 2014 16:19 #1532

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Should we even speculate that CC is trying to accomplish something in his new almost 90 day position ? Do we really even want such a possibility given the history ?


Why not??? Why else would he be around , except for trying to resolve "unfinished business"???

I wish him luck in trying to save some of his reputation and EARN some of the money he gets by "retiring" and not being kicked out. :bang:

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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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