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Hi Steve ...Wow. sorry to hear .
They used the femoral artery I'm assuming ...entered in your groin . I had a coronary angioplasty in 2016 via the femoral and had to lie real still afterwards ...risk of a blood clot.
The good news is that they didn't keep you over night or " send you down for surgery "
As I was laid out on the Cath table , right before inserting the catheter the interventionist leans over and say " If we can't fix this we may need to send you down for surgery "...meaning a bypass.
Gee thx Doc :--)
Can you share the results and does SWAV IVL technology have any role in helping you below the knee .
Just an FYI. RZLT is coming up on P2 2 data in DME in Q2 . Lot of insider buys recently
UNCY ...pivotal data end of Q2 . None of wife's dialysis patients are at serum phosphorous goals . They hate the current pills.
Risk with UNCY ...very powerful phosphorous lowering drug in 1 small pill swallowed with meals ....but are the stomach upsets etc more then what patients want to deal with .
Thx for the update
Good luck
Kiwi
Capt I agree , but you know my pt of view . Until we independently reproduce the Reduce -It USA data somehow ....even in a sub set say secondary prevention diabetics , sales will struggle ..
What's interesting ( to me at least ) re Dr Bhatt and the VERVE data ( HEART 1 trial I think ) is that eventually we may be able to lower LDL levels for many with a 1 shot and its done.
Pill burden is real .
Reduce the number of different meds many take each day is likely to enhance adherence for the remaining ...especially if backed up with independent data .
JMO
Kiwi
For those following Dr Bhatt
https://www.cgtlive.com/view/deepak-bhatt-encouraging-data-gene-editing-hypercholesteremia
Kiwi
North. SWAV's IVL technology is to crack calcium buildup in coronary arteries to enable better deployment of stents . ( This is just one of several applications of their technology . ). In Japan ...where they don't like stents ..this technology is used to crack the calcium ...which may form a ring in the arterial walls slowly constricting blood supply ...so that a catheter with a balloon can be inserted , inflated to expand the interior coronary diameter ...allowing better blood flow.
Its also used below the knee to increase blood flow and is often very useful for diabetics with foot ulcers that don't heal ...risk of amputation .
JL had this procedure done several years ago for lower leg pain.
Ironically Statin use may increase the risk of existing plaques becoming calcified.
It would be interesting to know if Vascepa had any role in preventing soft plaques from becoming calcified.
I've owned some SWAV from soon after its IPO .
Kiwi
(Reuters) -Johnson & Johnson is in talks to buy medical device maker Shockwave Medical, the Wall Street Journal reported on Tuesday, with a deal likely to help the healthcare giant expand its presence in cardiovascular devices.
Shockwave, a company that makes devices to treat heart disease, has a market capitalization of around $11 billion, according to LSEG data.
A deal could be finalized in the coming weeks, assuming talks don't fall apart, and it is also possible another suitor could emerge, the report said, citing people familiar with the matter.
Kiwi
SWAV. (Reuters)
What's your Lp (a) level ...come on ...everyone needs to know their levels now :--)
Kiwi
Yep they are definitely positioning for a sale .
So the big question will be sales of Xphazoh , and the UNCY pivotal trial with OLC .
UNCY has a number pf presentations at a major EU conference in May....trial results in June
So don't expect any deal until at least results of that trial ( the only near term competition ) is known
JMO
Kiwi
Yes but you should see the latest data on aspirin and Lp(a) .
I think I linked it previously
Kiwi
Ram. U won't die from heart disease ..JMO
My baseline LDL was 312 mg /dl ... Inherited HeFH ...no males lived past 62 . My father's fatal MI at 50 .
I'm now in my 70's thx to Statins since 1987 , Vascepa or high dose EPA supplements since around 2012 , and Reaptha the past couple of years.
The combination of all 3 ...LDL from 312 to a recent low of 20 mg/dl .
I redid that test to chk it was actually LDL 20 mg/dl !!
If we could have some well run double blinded clinical trial that showed Vascepa slowed the decline in cognitive function , risk of Alzheimer etc ...this stock would rocket . In our seventies ...my view is that we become more concerned with mental decline / loss of cognitive function ...then risk of an MI .
JMO
Kiwi
Does Dr Bhatt have that problem ?
Do I know my Lp(a) you asked
O and Ram My Lp(a) is in the normal range . I had an extensive lipid panel run as part of an angiogram / angioplasty in 2016 . I haven't had it checked since.
The overwhelming evidence is to drive LDL-C below 55 mg/dl for all secondary prevention CAD patients .
Kiwi
Capt more recent one about Lp ( a) and aspirin
https://www.ahajournals.org/doi/10.1161/JAHA.123.033562
Yes I agree its not all about LDL ( which is why I still take Vascepa ) , however the current thinking appears to ( at least my Kaiser Cardiologists view ) is to drive LDL as low as possible for secondary prevention CAD ( below 55 mg/dl ) add Vascepa for further risk reduction and aspirin for those with still elevated Lp(a) .
Crestor ( statin ) is now a very small pill in the 20mg dose ( which is the max dose Kaiser now recommends ) and generic
Aspirin low dose is also a very small pill and generic
Vascepa is 2 large capsules twice a day with still a significant copay for many... which may explain its sluggish sales
JMO
Kiwi
Capt. there have been plenty of studies showing generic aspirin may be effective at lowering high Lp( a) ...and therefore reducing this risk factor for those with high Lp(a)
Example
https://pubmed.ncbi.nlm.nih.gov/37527183/#:~:text=In%20secondary%20analyses%20of%20the,elevated%20Lp(a)%20levels.
Plus a 2024 Science direct article
Kiwi
So nothing about the 2 most recent trials using Vascepa ...MITIGATE and BRAVE ?
Kiwi
RMB. another example of Kaiser RWE
https://pubmed.ncbi.nlm.nih.gov/30225881/
RMB. They need to at least mine RWE ( real world experience ) data . As we have discussed before ...Kaiser for one, now has years of patient use data .
EG with Statins and ESKD patients
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8280931/
Hi North. The BRAVE trial with Vascepa is listed as being completed almost 6 mths ago .
Have they posted results ?
Can U provide an update on what's happening with that data
thx
Kiwi
Re
If they were only selling IBSRELA they would probably have been bt out already or negotiating a sale now. That drug has found a niche and is in demand.
Xphazoh is the unknown and may depend on what happens with UNCY's final trial with OLC .
If the final OLC trial succeeds ...that Co ( UNCY ) is very likely to be sold. Then the buyer will price OLC as less expensive then X ...for all those who hate the generics, and can afford the co pay of the new brand phosphorous lowering drugs.
OLC is 3 small pills a day swallowed with meals
X is 2 small pills ...1 in am , 1 in pm.
The advantage of OLC is that its a " condensed " version of Fosrenol ... a drug my wife already prescribes , so an easy transition
JMO
Kiwi
North. congrats on nearing 87 . As a T1 diabetic you are a trail blazer ...showing the marvels of modern medicine and a dose of good luck .
Be well
Kiwi
Ernie ...some thoughts on ARDX's strategy .
IBSRELA sales are strong ...co pay is around $400 a mth I think which this mostly working age population van afford.
With Xphazoh ...they may be following an Amgen / Repatha strategy .
When Repatha was first launched Amgen wanted $14,000 a yr for the sub Q drug . Insurers created huge roadblocks for coverage and most patients wouldn't pay the co pay anyway .
2 years later with poor sales Amgen cut the price to about $4,500 -$6,000 a year and insurers started covering , Co pay for patients ( I now use the drug ) is roughly $120 a month ...and sales have gone up significantly.
ARDX may provide discounts to patients ( help them with their copay ) to get them started ...then if they are still on X a year later slowly reduce their subsidy.
If UNCY's final trial succeeds with OLC ...one small pill with every meal ...swallowed not chewed ...they may / will be forced to lower their price when OLC launches ( maybe in 2025 ) assuming OLC is less expensive .
Theres also a question about the dialysis bundle ...will X and OLC be in the bundle ( which prefers generics ) or outside of the bundle enabling MD's to more freely prescribe
JMO
Kiwi
Moose. its the FDA that matters ...not some PR from AUPH .
Prescribers will follow the FDA PDF ...if they don't they become liable
Kiwi
What is the evidence it should be SOC ( standard of care ) ?
Prescribing PDF limits it use ...read the PDF .
Its a huge risk for the prescriber to prescribe this drug outside of the parameters ..including the monitoring requirements ,,,set forth in the PDF .
They won't do it .
Chk risk of hyperkalemia ...thats how many CKD patients die ...it sets of wild heart arrhythmias
RMB Lupkynis can be a difficult drug to use . https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213716s000lbl.pdf
It has a boxed warning , not recommended for eGFR < 45 , some time demanding monitoring requirements plus warnings .
Because its an expensive Brand drug the push back from the insurers via prior authorization requisitions ( did your patient try and fail Benylsta ...please document etc or the generics ...etc ) creates huge paper work for Nephrologists and their PA's
The Nephrologist and their PA's are under an intense work load already and to fight thru all the paper work / prior authorization document , monitor the drugs affect etc is more then what most want to deal with unless its almost the last chance for their LN patient to prevent decline into need for dialysis.
My wife knows of only 2 patients on Lupkynis ...largely because of the issues mentioned above .
The Ceo , from an earlier post , seems to be bailing .
I doubt any BP is interested .
JMO
Good luck
Kiwi
Thx Dew Its really helpful to have access to some one with your knowledge and experience .
Much appreciated
Kiwi
CFO was granted 275,000 options a $0 on 1/23/24 that start vesting in Jan 25
That wasnt enough for him
So far he has bt on the open market ....another 159,000 shares for himself and his kids.
139,000 of those since 2/16
Kiwi
Dew. Save me from myself ---)
RZLT
3/19. CFO open mkt purchase of 20,000 shares
3/19 CMO open mkt purchase of 10,000 shares
Kiwi
Budgetary Constraints: The Medicare dialysis bundle operates within a predefined budget allocated by the government. This budgetary constraint imposes a limit on overall spending for dialysis care, which helps control healthcare expenditures at the national level. Dialysis facilities must manage their resources effectively to operate within this budget while providing quality care to patients.
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My understanding is that it forces MD's to prescribe lower cost generics in order to stay within the predefined budget allocated by Medicare .
Staying outside the bundle allows a more direct access for the patient provided the Co pay is reasonable
just my take
Kiwi
RMB. It's good news if they can keep the new phosphorous lowering drugs out of the dialysis bundle . My understanding is that the bundle ( essentially a fixed price medicare / medicaid will pay for dialysis ) forces patients to the lowest cost generics.
ChatGPT
The dialysis bundle itself does not directly limit access to brand drugs. Instead, it focuses on optimizing care practices and resource utilization in the management of patients undergoing dialysis treatment, particularly those with end-stage renal disease (ESRD). However, there are broader healthcare policies and initiatives that may indirectly impact access to brand drugs for dialysis patients.
One of the ways access to brand drugs can be limited is through healthcare payers, such as insurance companies or government payers like Medicare or Medicaid, implementing formularies that preferentially cover generic drugs over brand-name drugs. Formularies are lists of medications that insurers cover, and they often include tiered structures where generics are placed on lower-cost tiers with lower copayments or coinsurance compared to brand-name drugs.
[/I]
And
The Medicare End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) is used to reimburse dialysis facilities for Medicare beneficiaries with ESRD. This system sets a base rate for dialysis treatments, with adjustments made for factors such as patient demographics, comorbidities, and geographic location.[/I]
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Little confusing but generally if the new drugs are in the bundle it limits what the govt will cover if at all ...just my take
Looks like a good funding deal this am .
Private placement with existing funds plus some new ones added . Vivo still in and added ...they in my experience ( SLNO ) are cutting edge in these niche speciality drugs .
This final trial is open label. The early patients enrolled have already completed most of the trial ...if not all of it.
I'm speculating that these investors must have had some indication that things were going well in the trial
JMO
Kiwi
Thx Dew .....did I ever post that I hate investing in biotech ..:--)
Kiwi
Its a plus for ARDX if X is kept out of the dialysis bundle .
X is Tenanapour ...same drug as used for IBSC.
Problem is the Co charges more per gm for the dialysis patients then for the IBSC patients
IBSC cost is $1200 a mth and patient co pay is about $400 . Generally a younger working age population.
Dialysis patients average age is mid 60's I think with limited income since they are in a dialysis chair 4 hrs a day , 3 times a week. .......yet ARDX is charging them a premium for the same drug !!!!
Kiwi
Ernie. I sold my position in ARDX some time ago ...see earlier posts and in full disclosure hold a position in UNCY .
The advocates for dialysis patients asked Rep Carter to represent their interests , present their concerns.
The most affordable phosphorous lower drugs are all generic. Problem is the patients hate them and most are nowhere near serum phosphorous goals. .
ARDX's X and UNCY's OLC are more patient friendly drugs likely to benefit these patients .
The problem is paying for them . In X's case around $3,000 a mth ...tier 5 means patient copay is around $1,000 a mth.
None of my wife's patients can afford this ...so won't be getting X unless ARDX provides a generous co pay buy down / coupon. .
If X ( and OLC ) go into the dialysis bundle it will severely limit any additional funds for X or OLC ....thats the concern and why Rep Carter is pushing legislation to keep the new phosphorus lower dugs out of the dialysis bundle .
Above is my layman's understanding of the issue.
Good luck
Kiwi
Ernie The dialysis payment bundle puts a cap on what the govt will pay thru Medicare / Medicaid for dialysis treatment .
Since the payment is capped ,it limits funds for new more expense brand drugs ( Xphazoh ) ...in favor of existing generic ( Selevmar ) .
Rep Carter is trying to delay this for several years to make X more affordable for dialysis patients ...unless an IV binder is approved ( which is unlikely near term )
Kiwi