PEB-Pacific Edge

[Shareguy]

Capital raise was at $1.35 in October 21. Since then sales have gone up and the company says the best is yet to come. Got to over $1.50.

According to Yahoo was $.78 on 29/7/22 which was the closing price before the Novitas bad news. The share price closed at $.44 1/8/22.

Of course the decision could still go against the company.

Will be interesting. I doubt we will no for sure till 12 June.

[Left Field]

Not the news that PEB holders were expecting or wanting as noted by Santiago on the other channel. Seems David Darling's deck building had dodgy foundations.

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39365&ver=80

In conclusion, the Cxbladder line of tests all suffer from the foundational problem of insufficient validation of their test in potentially confounding clinical circumstances including non-urothelial carcinoma malignancies and inflammatory conditions of the urinary tract. Cxbladder also demonstrates several population biases, including early papers with a strong bias towards male patients of European ancestry. The majority of Cxbladder papers avoid disclosing the PPV and number of false positives of their tests. Cxbladder tests generally have low PPVs (down to 15-16% as seen in Konety, et al 2019) and high numbers of false positives (also in Konety, et al 2019, there were 464 false positive results as compared to 86 true positive results).49 These values are significant in that false test results, particularly false positives, can lead to patient anxiety and distress among other procedural issues related to follow up for an inaccurate result. Most of the primary literature regarding Cxbladder test development and performance is funded, if not directly written by, the test's parent company, Pacific Edge Diagnostics. This conflict of interest must be taken into account when reviewing these papers. Finally, and most importantly, due to the insufficient representation of confounding factors in the validation populations, the Cxbladder tests have not been adequately vetted in the context of the Medicare population. Given all of these findings, the Cxbladder line of tests are considered not medically reasonable and necessary for Medicare patients.

It will be interesting to see what sort of spin PEB put on this news, but not looking good for holders.

[winner (n)]

Not the news that PEB holders were expecting or wanting as noted by Santiago on the other channel. Seems David Darling's deck building had dodgy foundations.

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39365&ver=80

In conclusion, the Cxbladder line of tests all suffer from the foundational problem of insufficient validation of their test in potentially confounding clinical circumstances including non-urothelial carcinoma malignancies and inflammatory conditions of the urinary tract. Cxbladder also demonstrates several population biases, including early papers with a strong bias towards male patients of European ancestry. The majority of Cxbladder papers avoid disclosing the PPV and number of false positives of their tests. Cxbladder tests generally have low PPVs (down to 15-16% as seen in Konety, et al 2019) and high numbers of false positives (also in Konety, et al 2019, there were 464 false positive results as compared to 86 true positive results).49 These values are significant in that false test results, particularly false positives, can lead to patient anxiety and distress among other procedural issues related to follow up for an inaccurate result. Most of the primary literature regarding Cxbladder test development and performance is funded, if not directly written by, the test's parent company, Pacific Edge Diagnostics. This conflict of interest must be taken into account when reviewing these papers. Finally, and most importantly, due to the insufficient representation of confounding factors in the validation populations, the Cxbladder tests have not been adequately vetted in the context of the Medicare population. Given all of these findings, the Cxbladder line of tests are considered not medically reasonable and necessary for Medicare patients.

It will be interesting to see what sort of spin PEB put on this news, but not looking good for holders.

Over there there was also mention of refunding what they had received for past tests

I not understand all this but that sounds like bad news

[Arbroath]

I've read through the CMS determination and saw no reference to refunding. Just that they lose coverage effective July 17th.

[BlackPeter]

Not the news that PEB holders were expecting or wanting as noted by Santiago on the other channel. Seems David Darling's deck building had dodgy foundations.

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39365&ver=80

In conclusion, the Cxbladder line of tests all suffer from the foundational problem of insufficient validation of their test in potentially confounding clinical circumstances including non-urothelial carcinoma malignancies and inflammatory conditions of the urinary tract. Cxbladder also demonstrates several population biases, including early papers with a strong bias towards male patients of European ancestry. The majority of Cxbladder papers avoid disclosing the PPV and number of false positives of their tests. Cxbladder tests generally have low PPVs (down to 15-16% as seen in Konety, et al 2019) and high numbers of false positives (also in Konety, et al 2019, there were 464 false positive results as compared to 86 true positive results).49 These values are significant in that false test results, particularly false positives, can lead to patient anxiety and distress among other procedural issues related to follow up for an inaccurate result. Most of the primary literature regarding Cxbladder test development and performance is funded, if not directly written by, the test's parent company, Pacific Edge Diagnostics. This conflict of interest must be taken into account when reviewing these papers. Finally, and most importantly, due to the insufficient representation of confounding factors in the validation populations, the Cxbladder tests have not been adequately vetted in the context of the Medicare population. Given all of these findings, the Cxbladder line of tests are considered not medically reasonable and necessary for Medicare patients.

It will be interesting to see what sort of spin PEB put on this news, but not looking good for holders.

Ouch - if this is confirmed it sounds like the beginning of the end of a 2 decades long rort to extract funds from gullible share holders.

Will be interesting to see which shares will replace the emerging void in share trader forums. I guess - sure, we have regularly some starlets shooting up and falling down, but continuing to keep the faithful invested for 2 decades without giving them any return, this clearly must count for something.

[Crackity]

They are dual listed on the ASX which is open today

[winner (n)]

They are dual listed on the ASX which is open today

Last trade on asx a couple of weeks ago ...might be it back to life

[Shareguy]

No doubt trading halt coming while they formulate suitable wording to downplay announcement.

I contacted the company yesterday when I heard about this and have had no response. Have sent them emails in the past and had no response so not really surprised.

[KW]

They are dual listed on the ASX which is open today

That raises an interesting question, does the stock get halted if it cant trade on both exchanges?  Seems unfair that ASX holders can get out today, but NZX ones are trapped until tomorrow.

Edit: Answer my own question, yes it does get halted.  There is an announcement and trading halt lodged on the ASX. 

[Greekwatchdog]

Expected https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02672815-2A1452985?access_token=83ff96335c2d45a094df02a206a39ff4

[Crackity]

Reasons for trading halt:

The company has become aware that late on Friday 2 June 2023 (US time) Novitas, the Medicare Administrative Contractor with jurisdiction for the company's US laboratory, finalized the proposed Local Coverage Determination (LCD) (L39365) covering reimbursement of Cxbladder by Medicare.

The information published by Novitas (the LCD, the associated Billing and Coding Article (A59125), and the Response to Comments Article (A59417)) is voluminous, detailed and complex. Pacific Edge is currently reviewing the LCD and needs time to assess the implications of the LCD on the Company


What a crock - doesn't anyone work weekends in PEBland?


 

[KW]

What a crock - doesn't anyone work weekends in PEBland?


 

You dont even need to work, you can just upload the document to Chat GPT4 and then ask it what it means 

[Shareguy]

You dont even need to work, you can just upload the document to Chat GPT4 and then ask it what it means 

Yes I did that and it came back with one word "SELL"

[Shareguy]

The conclusion at the end of the document is telling

insufficient validation of their test in potentially confounding clinical circumstances including non-urothelial carcinoma malignancies and inflammatory conditions of the urinary tract.

Cxbladder also demonstrates several population biases, including early papers with a strong bias towards male patients of European ancestry.

The majority of Cxbladder papers avoid disclosing the PPV and number of false positives of their tests. Cxbladder tests generally have low PPVs (down to 15-16% as seen in Konety, et al 2019) and high numbers of false positives (also in Konety, et al 2019, there were 464 false positive results as compared to 86 true positive results).49

These values are significant in that false test results, particularly false positives, can lead to patient anxiety and distress among other procedural issues related to follow up for an inaccurate result.

Most of the primary literature regarding Cxbladder test development and performance is funded, if not directly written by, the test's parent company, Pacific Edge Diagnostics. This conflict of interest must be taken into account when reviewing these papers.

Now if you add to the mix

That Cxbladder does not have the endorsement of the AUA or NCCN.

They can't even convince NZ health authorities for nationwide coverage.

The highly paid CEO who replaced David Darling who is quoted as saying "huge potential" and what a great company despite not buying any shares himself.

It's a cluster

[BlackPeter]

Yes I did that and it came back with one word "SELL"

You should ask the clever bot where to sell?

Hard to sell in a trading halt and I assume the liquidity afterwards might be still a bit thinner than normal ;