PEB-Pacific Edge

[Arbroath]

All your anecdotes might indicate is that the medical profession is often slow and stubborn to accept change. The fact Kaiser Permanente are in favour of CX bladder as is the AUA for me Carrie's a lot more weight than stories from a few years ago about a urologist that might've been educated in the 1970's

[bulltrap]

All your anecdotes might indicate is that the medical profession is often slow and stubborn to accept change. The fact Kaiser Permanente are in favour of CX bladder as is the AUA for me Carrie's a lot more weight than stories from a few years ago about a urologist that might've been educated in the 1970's

By 'recently' I meant in the last few months. Prior to cystoscopy, there was a CT scan and ultrasound. The urologist had his own ultrasound machine in his office. Nothing backward about it.

The view I've formed on this so far is that urinalysis tests are best as part of routine screening. Get a checkup every year, run an array of tests, and see what comes up.

I'm not sure if Cxbladder is suitable for such use - aside from needing to scale up volume and scale down cost, would the false positive rate be too high?

[LoungeLizard]

As said, CXBladder isn't an either/or option to a cystoscopy - it's an accurate, cheap and painless screening tool that augments but doesn't replace the more invasive procedure. In that sense it is just similar to a standard blood test used to screen, say, PSA levels for prostate cancer. You wouldn't want to immediately get a biopsy done if you were going to the bathroom more often - you would want to get a blood test first to determine whether the PSA level is within the "normal" range. If it outside the range you go and get the gold standard invasive procedure. Same with CX Bladder. It just makes sense to screen out those who may be symptomatic but don't actually have an issue.

I'm encourage by the response of the big 3 urological associations (who cover every urologist in the US) in essentially saying that Novitas seem to have misunderstood or ignored the usefulness of CXBladder as a diagnostic tool and that by not funding it, Medicare/Aid will end up paying more through performing more cystoscopies. Unfortunately there's so much politics and skullduggery in the US health industry that it's not a given that common sense will prevail and CXbladder etc will regain coverage. Therein lies the risk. But if does then there's no reason why the SP won't immediately return to previous levels (50c). That's a big payday for people prepared to take a punt at the current SP (13c)

[Basil]

Last I heard blood tests are quite cheap and you get a heck of a lot of information about a patient's health from one but the CX Bladder test was about $NZ400 and you get 1 bit of semi reliable information from it.  PSA tests are not super reliable either which is why if you have the courage, you should ask your doctor to check the other way every now and again.  That's another real "fun" experience lol
For me with PEB, they have burned through so much capital and cried wolf so many times that their existing resources will see them through to being cash flow positive, which has proved to be a lie so many times over and over now I call complete B.S. on their business model.
One final caution for punters, this is almost certain to exit the NZX50 in the December rebalance and all that index exit downward selling pressure on an illiquid stock, it isn't going to be pretty that's for sure!

[Waltzing]

yes bit of a shame this things hasnt taken off... or has it... was that it.. some brokers under water on this one?

ok your saying something is going to get in... my gosh not another HLG...like spike ... for the lucky one..

[Basil]

PEB and SML likely to get booted out of the NZX50 and replaced by GTX and TRA at the December rebalance.

[Highgate]

There has been a few directors buying recently although in relatively small $ values. However the buying of 8 million shares at a cost of $1,015,200 on 15th Sep by Anatole Masfen is significant.

[Shareguy]

There has been a few directors buying recently although in relatively small $ values. However the buying of 8 million shares at a cost of $1,015,200 on 15th Sep by Anatole Masfen is significant.

Welcolme to stocktalk. I still can't get over the fact that the board have only brought small values recently as you say apart from Anatole Masfen. Gosh apart from his purchase of 8m shares at $.1269 on the 15/9/23 he also brought 1.32m at $1.35 30/9/21 ouch. The ceo not buying any is a BIG red flag for me.

[Highgate]

Yes it is a concern. Perhaps he is happy enough with his 3m options and 386k ord shares. Interesting to see the 201k performance shares issued just prior to the close of submission phase.

[winner (n)]

Todays announcement has lots of long words and doesn't make much sense to me but I suppose it's not bad news even though market PRICE SENSITIVE

Word regulate in heading a bit of a worry though

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/419211/404203.pdf

[LoungeLizard]

Todays announcement has lots of long words and doesn't make much sense to me but I suppose it's not bad news even though market PRICE SENSITIVE

Word regulate in heading a bit of a worry though

http://nzx-prod-s7fsd7f98s.s3-website-ap-southeast-2.amazonaws.com/attachments/PEB/419211/404203.pdf

Hard for the layman to understand it's implications but imo, apart from perhaps more compliance costs, I wouldn't think it would overly affect products like CXBladdder which have already past trials/tests and a have proven to be safe and effective.Sounds to me like its more of an attempt to bring additional control and oversight of the medical devices industry.

[winner (n)]

Must have bad news ....share price heading down again

[LoungeLizard]

Must have bad news ....share price heading down again

Yep, market doesn't seem to like the news. Sigh.

[KW]

From the AFR
"Pacific Edge has flagged that new proposed changes to US Food and Drug Administration guidelines could result in more red tape for its bladder cancer diagnostic device, Cxbladder.
The proposed changes, if enacted, would require Pacific Edge to present evidence to the FDA that its tests were "safe and effective for their intended use" in addition to the current regulatory requirements."

[Shareguy]

The news is another nail.

From FDA announcement

The FDA is concerned patients could initiate unnecessary treatment, or delay or forego proper treatment altogether, based on inaccurate test results, which could result in harm, including worsening illness or death. For example, the FDA is aware of IVDs offered as LDTs that could have led to: patients being over- or under-treated for heart disease; patients with cancer being exposed to inappropriate therapies or not getting effective therapies.