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20-06-2019, 07:46 PM
#16991
Member
Originally Posted by kiwidollabill
I'm puzzled as to how naive they could be by taking the laboratory developed test pathway rather than FDA, particularly when you are reliant on a govt payment schedule. The other main cancer DNA tests I know of (or at least when my knowledge was better in this space a few years ago) all had FDA clearance otherwise they were sold as 'not for diagnostic use'. Moreover, the space for operating LDTs that are clearly for diagnostic use is going to get significantly harder (think the damage Theranos has done). Have they published a pathway to getting FDA cleared at all? Otherwise, getting on the CMS schedule might be essentially a no-go. Unless someone can point to other examples where comparabile LDTs are covered by CMS
Wow, do you think FDA approval would be any easier?
Look at CUV, I think its been circa 10 years and two different brand names and they are now just getting FDA approval, Hopefully anyway. Otherwise the 400% i am up will get smashed.
The goal posts are always changing,
https://www.fda.gov/medical-devices/...eveloped-tests
The good news is, PEB are one announcement away from being cashflow positive.
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20-06-2019, 07:55 PM
#16992
Member
Originally Posted by Nigelk
I think it's more complex than that.
My read is...
Patients need bladder tests
CMS want PEB to do them.
PEB want to do them, but don't have LCD inclusion
They can't be deferred (patient safety) PEB don't want another supplier to do them, so they do the tests.
PEB issues an invoice for the tests done but know they won't get paid until their LCD inclusion is obtained.
So issues are - will they get LCD inclusion? and, will they be paid for the tests done prior to receiving it?
Nigelk,
If you require a better understanding of the reimbursement situation look at MDX health, I spent near on a full week researching this to understand the reimbursement process and have previously posted links showing this. The goal posts are always changing in this industry and it is very high risk. PEB are so close, might be time for DD to buy a few on market.
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20-06-2019, 07:57 PM
#16993
Originally Posted by Carpenterjoe
...
The good news is, PEB are one announcement away from being cashflow positive.
...and have been for many years now and possibly for many years to come. Yep!
Even if these 17k tests do eventually get paid out it is the ability to generate excess cash on the day to day operations that would make this company viable.
Last edited by Snow Leopard; 20-06-2019 at 07:58 PM.
om mani peme hum
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20-06-2019, 08:04 PM
#16994
Originally Posted by Carpenterjoe
Wow, do you think FDA approval would be any easier?
Look at CUV, I think its been circa 10 years and two different brand names and they are now just getting FDA approval, Hopefully anyway. Otherwise the 400% i am up will get smashed.
The goal posts are always changing,
https://www.fda.gov/medical-devices/...eveloped-tests
The good news is, PEB are one announcement away from being cashflow positive.
How does getting money for 17k tests make them cashflow positive? lets say $500 per test by my calcs that is $8,500,000. So would still be operating at a loss.
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20-06-2019, 08:12 PM
#16995
Member
Originally Posted by Snow Leopard
...and have been for many years now and possibly for many years to come. Yep!
Even if these 17k tests do eventually get paid out it is the ability to generate excess cash on the day to day operations that would make this company viable.
The "pay out" isn't the important step, the "pay out" will be less than it should, circa half at a guess. But the reimbursement process will be open and ready to go.
10000 to 20000 tests at circa 1040 NZD per test.
Wait till guidelines catch up and those announcements will be profit in bags.
Will PEB need more money. Yes. In what form it comes in, I have no idea.
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20-06-2019, 08:23 PM
#16996
Member
Originally Posted by blackcap
How does getting money for 17k tests make them cashflow positive? lets say $500 per test by my calcs that is $8,500,000. So would still be operating at a loss.
Reimbursement rate is circa 1040 NZD per test, current market in only three countries is 15697 tests = $16,000,000 sales. chuck in some overdue reimbursement and the sentiment could be very different. Yes reimbursement rates are different in different countries. I am talking very roughly and with a glass half full.
Total laboratory throughput (which includes commercial sales as well as |
tests from User Programmes) grew to 15,697 tests in FY19, a 9% increase on |
FY18.
|
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21-06-2019, 09:12 AM
#16997
Member
Originally Posted by Carpenterjoe
Wow, do you think FDA approval would be any easier?
Look at CUV, I think its been circa 10 years and two different brand names and they are now just getting FDA approval, Hopefully anyway. Otherwise the 400% i am up will get smashed.
The goal posts are always changing,
https://www.fda.gov/medical-devices/...eveloped-tests
The good news is, PEB are one announcement away from being cashflow positive.
The easy short term choice is rarely the best long term one.
Look at what the real players do to make $
https://diagnostics.roche.com/global...tion-test.html
Lots of bankrupted companies were "one announcement away from being cashflow positive"
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21-06-2019, 09:36 AM
#16998
Originally Posted by kiwidollabill
This is where one has to grudgingly acknowledge the ability of DD & PEB to spin out the story from one capital raising to another.
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21-06-2019, 10:34 AM
#16999
Member
Originally Posted by kiwidollabill
Thanks will do,
Seems it relies on a Cobas amplification system and the system is rather large and at 50k+ a machine,
Out of interest do you need an invasive tumor sample to run the test?
Do you know how long is took Roche to research and gain approval for both technologies?
At first glance this is a targeted system that is used to decide what drugs to use to save someone from metastatic colorectal cancer, it is not a front line diagnostic test
At first glace this seems like comparing an apple with a brick.
This example is why the likes of PEB and MDX need to succeed.
Yes the big players have deep pockets are able to force decision making at all levels.
Happy Fridays
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21-06-2019, 10:50 AM
#17000
Member
Originally Posted by Carpenterjoe
Thanks will do,
Seems it relies on a Cobas amplification system and the system is rather large and at 50k+ a machine,
Out of interest do you need an invasive tumor sample to run the test?
Do you know how long is took Roche to research and gain approval for both technologies?
At first glance this is a targeted system that is used to decide what drugs to use to save someone from metastatic colorectal cancer, it is not a front line diagnostic test
At first glace this seems like comparing an apple with a brick.
This example is why the likes of PEB and MDX need to succeed.
Yes the big players have deep pockets are able to force decision making at all levels.
Happy Fridays
Do you realise that CXbladder is run on Roche Lightcyclers which are basically the non-FDA version of the Cobas.....????
I'll just leave the rest, its best not to make assessments on 'at first glance....'
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