PEB - Pacific Edge Ltd

[Minerbarejet]

Yet more evidence of how good this product is ...

http://www.nzdoctor.co.nz/un-doctored/2013/october-2013/03/cxbladder-excels-in-new-zealand.aspx

But I also wonder why all these "user programme studies" are necessary. Seems to me to be an excellent product with excellent results proven over clinical trial after clinical trial and now user programme after user programme. Why do they have to keep trying to prove how good cxbladder is? There should be enough there now for the medical stakeholders and naysayers alike to have the confidence to just get this thing out to the market as widespread as possible - especially now that the Dunedin laboratory is licensed to take any overflow.

I just get the feeling they are being made to "rehearse" the thing over and over .... perhaps the medical profession are being too cautious or too nervous ...just in case it is a success!!

In a word: Malpractice

[Toasty]

Yet more evidence of how good this product is ...

http://www.nzdoctor.co.nz/un-doctored/2013/october-2013/03/cxbladder-excels-in-new-zealand.aspx

But I also wonder why all these "user programme studies" are necessary. Seems to me to be an excellent product with excellent results proven over clinical trial after clinical trial and now user programme after user programme. Why do they have to keep trying to prove how good cxbladder is? There should be enough there now for the medical stakeholders and naysayers alike to have the confidence to just get this thing out to the market as widespread as possible - especially now that the Dunedin laboratory is licensed to take any overflow.

I just get the feeling they are being made to "rehearse" the thing over and over .... perhaps the medical profession are being too cautious or too nervous ...just in case it is a success!!

Maybe its like "I am Legend"? They are just waiting to make sure that Zombieism is kept to a minimum. I haven't seen any research papers on this yet. Being kept quiet perhaps?

[Minerbarejet]

To be published in March 2014

[MAC]

Yet more evidence of how good this product is ...

http://www.nzdoctor.co.nz/un-doctored/2013/october-2013/03/cxbladder-excels-in-new-zealand.aspx

But I also wonder why all these "user programme studies" are necessary. Seems to me to be an excellent product with excellent results proven over clinical trial after clinical trial and now user programme after user programme. Why do they have to keep trying to prove how good cxbladder is? There should be enough there now for the medical stakeholders and naysayers alike to have the confidence to just get this thing out to the market as widespread as possible - especially now that the Dunedin laboratory is licensed to take any overflow.

I just get the feeling they are being made to "rehearse" the thing over and over .... perhaps the medical profession are being too cautious or too nervous ...just in case it is a success!!

More like 'ground hog day' than 'I am legend' I reckon;

It must seem like deja vu to the good folk in the PEB lab's each time, but I just can't help but see it as a cleaver and cognisant marketing strategy, each health organisation needs to be convinced of a relatively new product, this may just be a more hands on and expedient process than having a salesman bug them off and on.

[Minerbarejet]

More like 'ground hog day' than 'I am legend' I reckon;

It must seem like deja vu to the good folk in the PEB lab's each time, but I just can't help but see it as a cleaver and cognisant marketing strategy, each health organisation needs to be convinced of a relatively new product, this may just be a more hands on and expedient process than having a salesman bug them off and on.

And for every health organisation convinced there will be a lot of share buyers take it up as well- waiting for the tipping point where institutions can no longer hold out. A good marketing strategy by the looks but what would I know.

[skid]

There are large corporations that can short cut the rules(think Monsanto,and all the pharma cos)
I suppose they could also put stumbling blocks in the way of a competitors product.
The American market is soooo complicated.

[skid]

Dont get me wrong.-Im not slamming the product.
I disagree with you that the large corporations use stand over tactics(or lobby the Gov. in their favor)but if this is bypassed-thats great.
As to whether it will rock their world or be a slow steady growth is yet to be seen.
So far since its introduction its been around 60+ and mid 50s (not claiming the market makes complete sense)
I like the product and would like to buy in on a dip(either in the co,or the market)
You obviously know the product inside and out-whether it rocks or not -Time will tell.
I hope it does(after a dip for me,thanx)
PS-Dont underestimate those large Multinational Corp. and what they can do.
If you have any doubt have a look at this documentary--you can skip to the part about monsanto in the secound part if you dont want to watch the whole thing
http://www.youtube.com/watch?v=Y888wVY5hzw

[MAC]

Dont get me wrong.-Im not slamming the product.
I disagree with you that the large corporations use stand over tactics(or lobby the Gov. in their favor)but if this is bypassed-thats great.
As to whether it will rock their world or be a slow steady growth is yet to be seen.
So far since its introduction its been around 60+ and mid 50s (not claiming the market makes complete sense)
I like the product and would like to buy in on a dip(either in the co,or the market)
You obviously know the product inside and out-whether it rocks or not -Time will tell.
I hope it does(after a dip for me,thanx)
PS-Dont underestimate those large Multinational Corp. and what they can do.
If you have any doubt have a look at this documentary--you can skip to the part about monsanto in the secound part if you dont want to watch the whole thing
http://www.youtube.com/watch?v=Y888wVY5hzw

It is common for biotech stocks to consolidate between successfully completing clinical trials and the start of monetising the technology. PEB has substantially de-risked over the last year, thus the SP will not continue to remain as undervalued as it is for long. The catalyst I believe will be reporting of first US sales next month, possibly sooner if a contract announcement comes along.

The SP is 32% discounted off its March High’s ($0.79), may I suggest that the dip you are waiting for is right here and now, probably last month to be picky and precise.

Try some recognised FA to gain a feel for upside potential, the US $100M goal revenue stream, provides me with a FY14 valuation of $1.25 and a FY16 valuation of $5.

Even if PEB achieve only half the sales they expect, this will still be one of the NZX stellar success stories of the next few years.

[skid]

Another thing to consider is that now that Obamacare has happened(if in fact it does not get postponed by the republicans) there will be alot of co.s lobbying hard for their products to get the nod.These gov. insurance schemes go for bulk deals on the best product for them.
If peb get the nod-then things would definitely ROCK --If some other co.with an inferior product does a better job at lobbying then the opposite would occur.
This could be a major force(completely outside of the product itself)
Who owns the inferior products--Are they big co.s with clout that could push through their bladder test with a bunch of their other products in a bulk deal? Will obama care even happen? So many questions in a complicated world.

[MAC]

Hancock’s, thank you for this analysis, it is difficult for most of us who are not technically proficient in this area to achieve a précis like this, most appreciated.

There have been a few posts about the repetitious mention of User Programs and some posts of a threat by the so-called Big Pharma Mafiosi.

There are actually a few good reasons why the ‘User Programs’ are an excellent way of marketing your product. The most important is that the Urologists and Clinicians over the years have been subject to a myriad of articles about procedures, tests, tools and instruments, software, business aids and charts that companies have been flogging off, the range is staggering and they may now be a sceptical about claims made.

If the Urologists and Clinicians could just browse the aisles of Wee Wees ‘R’ US, then they may be able to handle the product and read the box. This is not the case; and, there is also the issue Pacific Edge identified of Customer Pre-Purchase Dissonance.

NOW, the test kits themselves do not cost a lot to produce ~$US20 and the Urologists use of the kits means that their process will change to a certain extent, so the user program allows the vendor to market the whole kit and caboodle, which is obviously well received due to the number of programs that have been signed up. So, it is not just a matter of snake oil salesmen trying to hock off grandpas secret remedy.

The companies receiving the product and process are the beneficiaries of a financial and intellectual commitment from Pacific Edge, and the evidence of the success of the user programs means that the product and changes to their process are well received and they end up signing supply contracts with Pacific Edge Diagnostics. This process also bypasses Big Pharma and the likelihood that there are any stand over tactics (if this is really an issue, I do not believe it happens) are mitigated.

Cxbladder is the product that is now being marketed that far exceeds anything that has been marketed previously in the way of accuracy (specificity and sensitivity) that can replace Cytology and be used to limit the number of Cystoscopies.

We know that CertNDx bladder test was removed from market because it only indicated a possible issue and was a poor test. Cytology and NMP22 were good tests and were compared to Cxbladder in the clinical trials.

Hyperlink: Cxbladder Clinical trial Results

Here is a summary of the other tests and their limitations (if any) available to urologist, none come close to Cxbladder for accuracy, utilisation and ease of use, so the future is very promising and the User Programs are a very very smart way to market.

• The BTA (bladder tumour antigen) stat® test, (Polymedco Inc., Cortlandt Manor, NY) is a qualitative, point-of-care test with an immediate result that identifies a human complement factor H-related protein that was shown to be produced by several human bladder cell lines but not by other epithelial cell lines.

• The BTA stat® test is an in vitro immunoassay intended for the qualitative detection of bladder tumour-associated antigen in the urine of persons diagnosed with bladder cancer. The BTA TRAK® test (Polymedco Inc., Cortlandt Manor, NY) provides a quantitative determination of the same protein. This test requires trained personnel and a reference laboratory. Both tests have sensitivities comparable to that of cytology for high-grade tumours and better than cytology for low-grade tumours.

• Nuclear matrix protein 22 (NMP-22) is a protein associated with the nuclear mitotic apparatus. It is thought that this protein is released from the nuclei of tumor cells during apoptosis. Normally, only very low levels of NMP-22 can be detected in the urine, and elevated levels may be associated with bladder cancer. NMP-22 may be detected in the urine using an immunoassay.

• Fluorescence in situ hybridization (FISH) DNA probe technology has also been used to detect chromosomal abnormalities in voided urine to assist not only in bladder cancer surveillance but also in the initial identification of bladder cancer. FISH DNA probe technology is a technique to visualize nucleic acid sequences within cells by creating short sequences of fluorescently labeled, single-strand DNA, called probes, which match target sequences. The probes bind to complementary strands of DNA, allowing for identification of the location of the chromosomes targeted. UroVysion® (Vysis Inc., Downers Grove, IL) is a commercially available FISH test.

• The ImmunoCyt™ test (DiagnoCure Inc., Quebec) uses fluorescence immunohistochemistry with antibodies to a mucin glycoprotein and a carcinoembryonic antigen (CEA). These antigens are found on bladder tumor cells. The test is used for monitoring bladder cancer in conjunction with cytology and cystoscopy.

• In addition to the FDA-cleared tests, Predictive Biosciences (Lexington, MA) is marketing a urine-based test, called CertNDx TM, to assess Fibroblast Growth Factor Receptor 3 (FGFR3) mutations. The test is intended to be used in combination with cytology for identifying patients with haematuria at risk of bladder cancer. It is being offered through Predictive Bioscience’s network of Clinical Laboratory Improvement Amendment (CLIA) laboratories. FGFR3 mutations may be associated with lower-grade bladder tumours that have a good prognosis. (now removed from market)

So as you can see we have an exciting product that will rock the urologists and clinicians world in my humble opinion.