PEB - Pacific Edge Ltd

[psychic]

Yip,for sure.Its a strong vote of confidence however and reflects the potential from here.The market is a forward looking beast and so is ANZ.GLTA

Positive endorsement for sure, a pity the AUA are not so forward looking as having CxBladder as part of the go to standard is the big challenge for Pacific Edge.

AUA has just released its 2020 update:

http://www.auanet.org/guidelines/bla...sive-guideline

In surveillance of NMIBC, a clinician should not use urinary biomarkers in place of cystoscopic evaluation. (Strong Recommendation; Evidence Strength: Grade B)
In a patient with a history of low-risk cancer and a normal cystoscopy, a clinician should not routinely use a urinary biomarker or cytology during surveillance. (Expert Opinion)


From discussion doc guideline 9

The update review identified six new observational studies (in seven publications) including 1,604 participants and one systematic review relevant to this guideline statement. Since the guideline’s initial publication in 2016, several new urinary biomarkers have been developed to detect recurrent bladder cancer in NMIBC patients on surveillance.92-94 One such marker is CxBladder Monitor. It was designed as a high sensitivity rule-out test such that a negative result can be used to defer cystoscopy or confirm negative cystoscopy. In a cohort of 763 NMIBC patients on surveillance, CxBladder Monitor had a 93% sensitivity and 97% negative predictive value for recurrent NMIBC; however, the test specificity was not reported. Approximately one-third of patients had a negative test and could potentially avoid cystoscopy. The test performed well for both low- and high-grade recurrences92 and outperformed urine cytology, NMP22, and UroVysion FISH.95 While a patient with a negative test is unlikely to have recurrent NMIBC, a non-negative test requires continued cystoscopic surveillance and is not necessarily diagnostic of a recurrence. Although the early data on CxBladder Monitor are promising, further validation studies are needed to determine if a negative test is sufficient to defer surveillance cystoscopy and what the clinical implications are of a non-negative test.

From discussion doc guideline 10

The previously discussed CxBladder Monitor was designed to detect recurrent bladder cancer in NMIBC patients on surveillance. Although this biomarker performed well for intermediate- and high-risk NMIBC patients in a large cohort study, its sensitivity was only 53% in a small subset of patients with an EORTC risk score of 0, which is equivalent to AUA low-risk.92 As such, there is currently insufficient evidence to recommend CxBladder Monitor during surveillance for low-risk patients.

[Biscuit]

Started buying today, bit late perhaps but better late than never. Could be an interesting investment from here if they've finally sorted out their s***e.

[tango]

Started buying today, bit late perhaps but better late than never. Could be an interesting investment from here if they've finally sorted out their s***e.

If the predictions that this stock will make it into NZX50 are correct then you jumped on board at the right time. Most brokers haven't analysed this stock so it's not on their radar. Now is the time to get in if you have done your research and like the company and its fundamentals.

[tango]

Positive endorsement for sure, a pity the AUA are not so forward looking as having CxBladder as part of the go to standard is the big challenge for Pacific Edge.

AUA has just released its 2020 update:

http://www.auanet.org/guidelines/bla...sive-guideline

In surveillance of NMIBC, a clinician should not use urinary biomarkers in place of cystoscopic evaluation. (Strong Recommendation; Evidence Strength: Grade B)
In a patient with a history of low-risk cancer and a normal cystoscopy, a clinician should not routinely use a urinary biomarker or cytology during surveillance. (Expert Opinion)


From discussion doc guideline 9

The update review identified six new observational studies (in seven publications) including 1,604 participants and one systematic review relevant to this guideline statement. Since the guideline’s initial publication in 2016, several new urinary biomarkers have been developed to detect recurrent bladder cancer in NMIBC patients on surveillance.92-94 One such marker is CxBladder Monitor. It was designed as a high sensitivity rule-out test such that a negative result can be used to defer cystoscopy or confirm negative cystoscopy. In a cohort of 763 NMIBC patients on surveillance, CxBladder Monitor had a 93% sensitivity and 97% negative predictive value for recurrent NMIBC; however, the test specificity was not reported. Approximately one-third of patients had a negative test and could potentially avoid cystoscopy. The test performed well for both low- and high-grade recurrences92 and outperformed urine cytology, NMP22, and UroVysion FISH.95 While a patient with a negative test is unlikely to have recurrent NMIBC, a non-negative test requires continued cystoscopic surveillance and is not necessarily diagnostic of a recurrence. Although the early data on CxBladder Monitor are promising, further validation studies are needed to determine if a negative test is sufficient to defer surveillance cystoscopy and what the clinical implications are of a non-negative test.

From discussion doc guideline 10

The previously discussed CxBladder Monitor was designed to detect recurrent bladder cancer in NMIBC patients on surveillance. Although this biomarker performed well for intermediate- and high-risk NMIBC patients in a large cohort study, its sensitivity was only 53% in a small subset of patients with an EORTC risk score of 0, which is equivalent to AUA low-risk.92 As such, there is currently insufficient evidence to recommend CxBladder Monitor during surveillance for low-risk patients.

Thanks for this. A mix of good and bad news but PEB have plenty of $$$ now for further validation testing and a marketing push

[psychic]

Thanks for this. A mix of good and bad news but PEB have plenty of $$$ now for further validation testing and a marketing push

These things take time eh
Here is a list of current clinical trials (monitor, triage and detect)
The monitor study was completed back in 2016 but still no results posted. Whats that about?

https://clinicaltrials.gov/ct2/resul...&rank=2#rowId1

[ba9]

Thank you for posting this. Psyshic - Post

In his recent interview, CEO David Darling specifically answers about guidelines and adoption with reference to NCCN and AUA (American urological association)

NCCN - Reviewed ever year. Currently 2B. Pushing for 2A
AUA - Reviewed every four years. Still waiting on final release of AUA guidelines. Hoping for inclusion this time.

Below interview link - Originally posted by Carpenterjoe. Thank you.

From around 12 minutes 40 secs.
https://www.edisongroup.com/wp-conte...ison-Talks.mp3

[psychic]

Don't really buy Dave's claim that Cxbladder has been adopted and given a 2b (weak) recommendation. The NCCN updated guidelines don't mention CxBladder specifically at all! They just reviewed the guidelines and said it was okay to also consider using Urinary biomarkers (generally?). Hardly specific support or endorsement for Cxbladder but Pacific Edge are trumpeting this is as an endorsement and really who of us here know how these things work. Perhaps the next NCCN review in 12 months will mention Cxbladder.

And now we wait another 4 years for the next AUA review? zzzzzzzzzzzz

[Minerbarejet]

In a patient with a history of low-risk cancer and a normal cystoscopy, a clinician should not routinely use a urinary biomarker or cytology during surveillance. (Expert Opinion)
This does not say they cant use it and indicates the opportunity to use it in cases where the cystoscopy is not normal as well as any other time.

As far as the AUA is concerned I think there may be some "patch protection" going on.
Every four years is no way to keep up with developments especially under the present medical disaster of Covid 19 and the need for much less contact. Some quick thinking and utilization of what is available should be taking place.
The " this is the way we have always done it" dissonance encrusted attitude suggests the wagons are being encircled as a defence to any suggestion that their predetermined gold standards might just possibly be under threat.

[Balance]

Don't really buy Dave's claim that Cxbladder has been adopted and given a 2b (weak) recommendation. The NCCN updated guidelines don't mention CxBladder specifically at all! They just reviewed the guidelines and said it was okay to also consider using Urinary biomarkers (generally?). Hardly specific support or endorsement for Cxbladder but Pacific Edge are trumpeting this is as an endorsement and really who of us here know how these things work. Perhaps the next NCCN review in 12 months will mention Cxbladder.

And now we wait another 4 years for the next AUA review? zzzzzzzzzzzz

Thanks, psychic - all information is very useful to assessing the potential for success or lack thereof for PEB in the US.

My view is very clear that PEB has been amateurish in their approach to getting Its products approved, accepted and distributed for wide use in the US.

6 long years to finally getting traction but that’s behind the company now imo. Better late than never - and PEB has been very fortunate no competing product has emerged as yet to knock its products out of the game!

Kaiser and CMS & LCD inclusion provide credibility & endorsement and PEB has actually got the cash now in the bank to aggressively market & promote its products to customers (probably the first time PEB can really splash out without sweating bricks).

I believe that’s the strong rationale for ANZ to approach PEB with its $22m offer.

[tango]

Thanks, psychic - all information is very useful to assessing the potential for success or lack thereof for PEB in the US.

My view is very clear that PEB has been amateurish in their approach to getting Its products approved, accepted and distributed for wide use in the US.

6 long years to finally getting traction but that’s behind the company now imo. Better late than never - and PEB has been very fortunate no competing product has emerged as yet to knock its products out of the game!

Kaiser and CMS & LCD inclusion provide credibility & endorsement and PEB has actually got the cash now in the bank to aggressively market & promote its products to customers (probably the first time PEB can really splash out without sweating bricks).

I believe that’s the strong rationale for ANZ to approach PEB with its $22m offer.

Interesting comment. I am relatively new to PEB but catching up.
A lot of these companies have great products but poor marketing. Hopefully they now have the right people and plan in place. They certainly have the funds...