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14-08-2014, 02:10 AM
#8671
Originally Posted by Minerbarejet
Go to the FDA website and use the search engine for cxBladder - any luck?
Think the goalposts are being shifted with this and we will have to wait for final positioning by FDA. It looks as if there is an attempt to get everything under the fda umbrella .Full Cms approval would follow in quick succession by the sound of whats happened with Exact.
Some of the warnings with using the kit are a bit weird.
Possible hand strain opening and closing the lid on the box?
What are they using, Gorilla Glue? Guess they dont want to come unstuck.
Tried the search and got some hits but they were all things with cx in other contexts and various uses of the word bladder--I couldnt find CX Bladder anywhere--am I missing something?
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14-08-2014, 02:26 AM
#8672
Originally Posted by skid
maybe so..but I have certainly not misunderstood that nothing has been said about CX on any of the cancer or medical sites Ive been searching in the US--Have you had any better luck?
Have you looked on Inspire, Bladder Cancer Advocacy Network.
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14-08-2014, 03:10 AM
#8673
Member
Originally Posted by skid
maybe so..but I have certainly not misunderstood that nothing has been said about CX on any of the cancer or medical sites Ive been searching in the US--Have you had any better luck?
Blue Cross / Blue Sheild are definitely aware of cxBladder.
Its mentioned - albeit briefly - here: https://www.bcbsnc.com/assets/servic...der_cancer.pdf
Have a look under the "Urinary Tumor Markers for Bladder Cancer"
Also mentions that at the time of writing, cxBladder is not approved by the FDA
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14-08-2014, 07:01 AM
#8674
Originally Posted by AndyLP
Blue Cross / Blue Sheild are definitely aware of cxBladder.
Its mentioned - albeit briefly - here: https://www.bcbsnc.com/assets/servic...der_cancer.pdf
Have a look under the "Urinary Tumor Markers for Bladder Cancer"
Also mentions that at the time of writing, cxBladder is not approved by the FDA
And in addition that reviews would be carried out by BC/BS every six months.
Various States have also approved the construction of the lab for PEDUSA and issued certificates. They must know what it was for.
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14-08-2014, 07:22 AM
#8675
Originally Posted by skid
Tried the search and got some hits but they were all things with cx in other contexts and various uses of the word bladder--I couldnt find CX Bladder anywhere--am I missing something?
Thats what I ran into as well on that FDA site, "we haven't heard of it so far". Why not? Because cxBladder, being an LDT, has not been required to have our approval to operate, therefore, its not in the FDA system. This is what is about to change apparently, hence the delay while things are sorted. Maybe PEB can get into the parallel experiment, would seem to be a similar candidate to Exact.
Found it interesting that although FDA approved the product they only said it could be used, not that it was recommended as a replacement for the current process.
Makes you think though, 17.00 a share for Exact and not even recommended as mainstream.
Last edited by Minerbarejet; 14-08-2014 at 07:50 AM.
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14-08-2014, 08:23 AM
#8676
Speak of the devil. Pacific Edge Alert on Google comes up with this this morning.
A Licence to operate the lab in Pennsylvania
https://www.google.com/url?rct=j&sa=...1_87fJDWUvRZpA
Last edited by Minerbarejet; 14-08-2014 at 08:24 AM.
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14-08-2014, 10:19 AM
#8677
Seems to be plenty of exposure for Cxbladder online for a product that’s in its first year of commercialisation, should be quite a lot more after five years.
It would be interesting to ask Jackie Walker if Pacific Edge should pursue FDA approval, understanding that it’s not necessary, but just because it may be one less matter for the sales folk to clarify when door knocking, and the FDA do seem to want to head in that direction also. Such things can do no harm.
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14-08-2014, 01:49 PM
#8678
Meow?
Chairman Swann better have a good explanation at the AGM.
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14-08-2014, 01:55 PM
#8679
Originally Posted by Balance
Meow?
Chairman Swann better have a good explanation at the AGM.
A good explanation for ???
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14-08-2014, 01:58 PM
#8680
Member
Originally Posted by MAC
A good explanation for ???
Volatility in the SP today?
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