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This is the regulation that ICX is hoping for, right?


#1

http://www.przoom.com/news/19200/

I’m not familiar with the political process in the UK; does anyone know what happens after this? How long will it take before the regulation becomes fully implemented? Of course, the sooner that happens, the sooner TRC can (hopefully) become commercialized without a Phase III.
Thanks.


#2

Will TCR fall under this ruling or will it still have to be governed by the MHRA ???


#3

» http://www.przoom.com/news/19200/
»
» I’m not familiar with the political process in the UK; does anyone know
» what happens after this? How long will it take before the regulation
» becomes fully implemented? Of course, the sooner that happens, the sooner
» TRC can (hopefully) become commercialized without a Phase III.
» Thanks.

They are not hoping for anything. As far as I know the last time they said something about it was that they do not expect this legislation change to have ANY effect on the development of ICX-TRC.


#4

» » http://www.przoom.com/news/19200/
» »
» » I’m not familiar with the political process in the UK; does anyone know
» » what happens after this? How long will it take before the regulation
» » becomes fully implemented? Of course, the sooner that happens, the
» sooner
» » TRC can (hopefully) become commercialized without a Phase III.
» » Thanks.
»
» They are not hoping for anything. As far as I know the last time they said
» something about it was that they do not expect this legislation change to
» have ANY effect on the development of ICX-TRC.

That’s weird. That kind of goes against their idea of commercialization in 2008. I thought the new regulation was the key to a 2008 release.


#5

Debris, I found the language that you were talking about in their corporate statement released in April, 2007:

“The new legislation will also probably
regulate ICX-TRC and ICX-SKN as ATMPs
which are both currently regulated as
medicines in the UK. We do not expect
the new regulation to have any significant
effect on the development path of either
of these products.”

from: http://www.intercytex.com/icx/investors/rep/2007-04-12/2007-04-12.pdf


#6

» Debris, I found the language that you were talking about in their corporate
» statement released in April, 2007:
»
» “The new legislation will also probably
» regulate ICX-TRC and ICX-SKN as ATMPs
» which are both currently regulated as
» medicines in the UK. We do not expect
» the new regulation to have any significant
» effect on the development path of either
» of these products.”
»
» from:
» http://www.intercytex.com/icx/investors/rep/2007-04-12/2007-04-12.pdf

yeah that’s exactly it.


#7

The ABHI is a trade association of medical manufacturers, who it seems, are not involved in the government in any way. It’s just an industry nod, showing they approve of the regulation.

As far as I’m aware the EU regulation has been approved and is in a provisional state, waiting to be implemented. What the relationship is between the EU and the MHRA I couldn’t say for sure, the UK as a member of the EU should be beholden to new laws, but the whole thing is such a ridiculous beauracracy clsuterf**k it makes your head spin. Personally, I’m following the Intercytex line (will be approved in 2008, no adverse effect of development) until i see something else.

On reading the year end results PDF on the ICX site, Higgins says they received confirmation from the MHRA (I think, it was some agency) that Vavleta could be sold without a licence, based on early results. Different thing really.


#8

» The ABHI is a trade association of medical manufacturers, who it seems, are
» not involved in the government in any way. It’s just an industry nod,
» showing they approve of the regulation.
»
» As far as I’m aware the EU regulation has been approved and is in a
» provisional state, waiting to be implemented. What the relationship is
» between the EU and the MHRA I couldn’t say for sure, the UK as a member of
» the EU should be beholden to new laws, but the whole thing is such a
» ridiculous beauracracy clsuterf**k it makes your head spin. Personally,
» I’m following the Intercytex line (will be approved in 2008, no adverse
» effect of development) until i see something else.
»
» On reading the year end results PDF on the ICX site, Higgins says they
» received confirmation from the MHRA (I think, it was some agency) that
» Vavleta could be sold without a licence, based on early results.
» Different thing really.

What’s confusing is that he says: TRC will be regulated by the new legislation (or he thinks it will) yet the timeline will not be affected. That contradicts the idea that Valveta comes under the new regulation and can be commercialized after Phase II. Does anyone know why this is?


#9

» » The ABHI is a trade association of medical manufacturers, who it seems,
» are
» » not involved in the government in any way. It’s just an industry nod,
» » showing they approve of the regulation.
» »
» » As far as I’m aware the EU regulation has been approved and is in a
» » provisional state, waiting to be implemented. What the relationship is
» » between the EU and the MHRA I couldn’t say for sure, the UK as a member
» of
» » the EU should be beholden to new laws, but the whole thing is such a
» » ridiculous beauracracy clsuterf**k it makes your head spin.
» Personally,
» » I’m following the Intercytex line (will be approved in 2008, no adverse
» » effect of development) until i see something else.
» »
» » On reading the year end results PDF on the ICX site, Higgins says they
» » received confirmation from the MHRA (I think, it was some agency) that
» » Vavleta could be sold without a licence, based on early results.
» » Different thing really.
»
»
» What’s confusing is that he says: TRC will be regulated by the new
» legislation (or he thinks it will) yet the timeline will not be affected.
» That contradicts the idea that Valveta comes under the new regulation and
» can be commercialized after Phase II. Does anyone know why this is?

I think because vavelta is not considered an ATMP.