PEB - Pacific Edge Ltd

[skid]

OMG. Someone oughta call PEB with this info. What were they thinking?
Seriously - Guys? They got this, ok?

They are thinking right--They are going after FDA approval----They are not fooling themselves that anything less is suffice--Its us that may have to adjust our thinking--but if it helps--YEA PEB!!!
Howzat (only 4 more days and all will be richhhhhhhhh! )

[psychic]

They are thinking right--They are going after FDA approval----They are not fooling themselves that anything less is suffice--Its us that may have to adjust our thinking--but if it helps--YEA PEB!!!
Howzat (only 4 more days and all will be richhhhhhhhh! )

Sorry, I was being sarcastic Skid. Never works. My point was that PEB actually have a pretty good grasp of the hurdles they need to cross. If it had been important to obtain FDA approval at this stage, they would have done something about it. Have a little faith. They have not gone to the US with the plan of flogging these tests off on ebay.

[steve06]

Here is an article and a site providing more insight into CLIA approved tests and reasons for FDA approval.

http://news.sciencemag.org/health/20...eveloped-tests

http://www.fda.gov/MedicalDevices/Pr.../ucm407296.htm

http://www.fda.gov/downloads/Medical.../UCM407409.pdf

[psychic]

Here is an article and a site providing more insight into CLIA approved tests and reasons for FDA approval.

http://news.sciencemag.org/health/20...eveloped-tests

http://www.fda.gov/MedicalDevices/Pr.../ucm407296.htm

http://www.fda.gov/downloads/Medical.../UCM407409.pdf

So you understand and agree with MAC now?

[skid]

FROM the 1st article....
. Although CLIA ensures that labs perform a test properly, it doesn’t address the clinical validity of the test itself—how accurately it measures a patient’s condition. “We have a responsibility to provide patients with greater certainty,” Shuren said.

And it goes on to talk about how the FDA may regulate some of the tests

CLIA test may be ok'd--but FDA approved they aint (not yet)

[psychic]

FROM the 1st article....
. Although CLIA ensures that labs perform a test properly, it doesn’t address the clinical validity of the test itself—how accurately it measures a patient’s condition. “We have a responsibility to provide patients with greater certainty,” Shuren said.

And it goes on to talk about how the FDA may regulate some of the tests

CLIA test may be ok'd--but FDA approved they aint (not yet)

Correct. And for the last time, they have not needed FDA approval thus far. It has not been an impediment. The US Urologists understand LDT's.
Yes, the FDA may regulate - may even take them 9 years...
MAC has gone over this. It will happen when needed but it is not something that need concern us now,

[MAC]

Well, because you know so much more than the experienced within market Pacific Edge CEO and executive sales staff, and because you know so much more than the internationally recognised Pacific Edge advisory board, then you probably actually think you might even be right.

An LTD process does place the emphasis on the company to demonstrate clinical validity. It offers a complementary approach to the Pacific Edge strategic plan in targeting large health organisations who must assess that validity for themselves as a routine adoption practice.

The customers and prospective customers of Pacific Edge are insurers, HMO’s, NPN’s, CMS, VA, and DHB’s.

Those customers are not lay people in the street, they are experienced health professional managers, and Pacific Edge retain independent clinical trials, studies and user programmes outcomes, with a lot more on the way, as a demonstration of that validity.

And what those mangers see is performance better than any other test in the market place.

[robbo24]

I've got a bet with BFG for a pack of Winnie Blue 20s depending on where PEB ends up at the end of the month.

Low to mid 80s and I win a pack of Winnie Blues.

I don't even smoke but still - Winnie Blues mate.

[steve06]

I am not claiming to be the top expert on all this, nor to know the clinical efficacy of Cxbladder. I am presenting what I know about LDTs and the limitations of CLIA approved tests, which some posters here do not fully understand (CLIA approval affirms test performance, but does not provide clinical validity). We will know with more certainty the clinical efficacy of Cxbladder with the completion of clinical trials and validations in the near future, or possibly in four days time...?

[skid]

Sorry, I was being sarcastic Skid. Never works. My point was that PEB actually have a pretty good grasp of the hurdles they need to cross. If it had been important to obtain FDA approval at this stage, they would have done something about it. Have a little faith. They have not gone to the US with the plan of flogging these tests off on ebay.

I got the sarcasm
I was just making the point that sometimes I think we misinterpret what PEB is up to--They are going after FDA approval so they must think its important,but I think it is a time consuming process.(If they were concerned about looking cheesy with foot in the door stuff--they would have not come up with the internet order test they have here)or maybe its ok to be cheesy in NZ but not the States
I believe that this is going to take more time than some are expecting--Thats not the end of the world,but alot are still looking at this with a gamblers point of view(like they got a taste of before) and I dont think this is the type of product that is going to suddenly fly off the shelves,like some new software that appeals to the wow factor.
Its a tiny minnow in a gigantic sea of medical heavy weights. It will take time and I think those that are expecting the fireworks of before may punish this lag-which,if Im right,will not fit in to this way of thinking.
I may be completely wrong and we will see fireworks,but it may be just a blip along the way.
In some ways I agree with Mac that its just a step in a long process(sales) What I disagree with him is the effect it will have on investors if they are still slow off the blocks.

(just thought I would fill some of the vacume between now and the report this fri