PEB - Pacific Edge Ltd

[Casino]

As I posted earlier in the year - after going to a talk by DD - CMS is now expected early next year (2015)

That's great but the place for this is the NZX not the Herald, not the ODT and certainly not sharetrader (no offence).

[MAC]

I remember reading that CMS could go through in early 2014. Obviously that didn't happen and we have not been given any indication how close they are to finalising the deal. I can imagine that getting CMS coverage isn't easy at the moment with all this regulatory chaos in the US. I also don't expect sales for the period ending September but I want to be talked to/kept informed.

It does seem to be a staged sequential process that does take time, it's probable they have indeed been accruing those revenues since early 2014, so we may consider that is all fine, would be nice to see a final conclusion by years end as anticipated.

But at the end of the day, whether the final conclusion occurred tomorrow or in March next year the accumulated revenues would still fall into the FY15 reporting period, not HY15.

No one should retain a false expectation of Medicare/Medicaid revenues at HY15 reporting in November.

[Minerbarejet]

Just to put things in context a bit.
The original time frame for CMS coverage was expected to be August 2014 when lengthy negotiations would be concluded. This I believe was before the current upheaval in the US system. So far there has been a delay of a whole 6 weeks. At the meeting in Auckland Newguy believed DD had said that it would be late 2014 or early 2015. So far he is right. This accumulation of medicare payments is a fairly recent appearance although we were aware that cxbladder was available for their use. How much is the big question and when do we see the folding stuff. In addition I think the only announcement you will get is that CMS has started coverage, details of the amount involved would only appear in financial accounts for HY or FY. Hardly think it is something they would put out as part of any announcement.
Must agree that the waiting seems interminable at times. Never ceases to amaze me how days and years can fly by so fast and months take forever.

[Minerbarejet]

https://www.google.co.nz/url?sa=t&rc...y7Vwl4vH6trCDA


This may give a view of what goes on with a small company much the same as PEB and its pathway through the mire of regulation. Interesting to note, from elsewhere, that they have just received CMS coverage and have recently signed up FEDMED. Also interesting that their test is $3000.00 to $4000.00. Its an assay for breast cancer I know but it sounds very similar to cxbladder with what is involved.
Havent fully explored all this yet as there are all kinds of links. Something for a wet Sunday afternoon perhaps.


This came up on a Genomeweb alert which has from time to time come up with a lot of interesting stuff. Well worth signing up for at no cost.
Googling the company brings up a lot of other pages. Work in progress.

[barney]

http://www.crd.york.ac.uk/PROSPERO/d...CRD42014013284

[MAC]

http://www.crd.york.ac.uk/PROSPERO/d...CRD42014013284

They are collating in the UK on behalf of the AHRQ,

http://effectivehealthcare.ahrq.gov/...col-140721.pdf

Pacific Edge are participating and, as I understand, have provided their clinical information. The results may well indeed demonstrate Cxbladder as best in breed amongst the urinary biomaker tests available, let's see. Perhaps it's possible that this review may also lead to some adjustment to the gold standard also.

[MAC]

Yes, it is certainly one of the most important developments this year for Pacific Edge.

If Cxbladder is demonstrated as adoptable within an endorsed best practice by government research agencies with that sort of clout it may even start to make that 10% market share goal seem a really quite light on ambition.

Results in February, hopefully it won’t be one of those studies that recommends extensive further investigation, would be satisfying as a shareholder to see some form of conclusive acknowledgement.

It’s the sort of prospective endorsement that just simply couldn’t be bought with even the largest of marketing budgets, couldn't be easily ignored by even the most stoic urology practice.

[RTM]

Does anyone have an idea on when the review will be completed ? Yes, if its favourable for PEB, then that will be great, but I guess there is a chance that it may not be as positive as we all hope/think it might be. I learnt a new term on another thread today which made me think a wee bit about myself

".....you have a strong tendency towards confirmation bias."

Disc: Yes, I have some and intend to hold till the end.

Hi Barney & MAC, this is really excellent news. In fact the timing is absolutely perfect, Pacific Edge Diagnostics are into a commercial roll-out with ‘User Program’ data becoming available; best test on the market and statistically better (published results) than the incumbents (cytology, BTA, NMP22 etc.).

A totally independent and thorough investigation and, for CxBladder to be included really means it is well and truly on the radar in the United States.

To be published in such a wide ranging review that will encompass all clinical practices and challenge (review) all process will certainly put CxBladder directly under the noses of urologists, GP’s and clinicians.

The American AHRQ (Agency for Healthcare Research and Quality) has commissioned the Effective Health Care Program to complete a review of the evidence for:

PROJECT NAME: Emerging Approaches to Diagnosis and Treatment of Non-Muscle-Invasive Bladder Cancer.

AUTHORED: The Oregon Health & Science University, Pacific Northwest Evidence-Based Practice Center.

AND, obviously the NCCN (National Comprehensive Cancer Network) and AUA (American Urological Association) will take note of the results and it could easily influence or guide their decisions and content of future publications.

The anticipated completion date is 9th February 2015, and I think it is just an awesome opportunity that will have major benefits for Pacific Edge Diagnostics.

HyperLink: Emerging Approaches to Diagnosis & Treatment Bladder Cancer

As I understand it; The Centre for Reviews and Dissemination is a department of the University of York and PROSPERO is their International Prospective Register of Systematic Reviews; however the review will not be undertaken by the UK, it will be American.

[psychic]

Does anyone have an idea on when the review will be completed ? Yes, if its favourable for PEB, then that will be great, but I guess there is a chance that it may not be as positive as we all hope/think it might be. I learnt a new term on another thread today which made me think a wee bit about myself

".....you have a strong tendency towards confirmation bias."

Disc: Yes, I have some and intend to hold till the end.

Hi RTM. Public submissions closed 3/10, the final review is due for completion 9th Feb 2015

My thoughts, It'd be nice, but unlikely likely the review will come out and suggest using Cxbladder and throw out everything else. The Health game being conservative as it is, I'm hoping it will simply introduce Cxbladder into the clinical pathway with a view to increasing use and endorsement as time goes on.
The big thing is that the review is LIMITED to the existing FDA approved biomarkers AND Cxbladder. None other. That it is specifically included in the Review, speaks volumes already to me.

[psychic]

Note also that Medicare will typically follow AHRQ recommendation. Insurers will follow.
Yes, huge....