Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
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
1 min read
SAVE
Legislation pushes for a delay in placing phosphate binders in the ESRD payment bundle
Add topic to email alerts
Key takeaways:
The Kidney Patient Act would delay placement of oral phosphate binders into the dialysis payment bundle.
Binders would be placed in the bundle if an injectable version receives FDA approval.
Congress is reviewing legislation that would delay inclusion of oral phosphate binders into the End-Stage Renal Disease Prospective Payment System bundled payment system.
NNI0324Carter_Graphic_01
CMS currently has plans to include oral binders in the bundle by Jan. 1, 2025, but the Kidney Patient Act (H.R. 5074), sponsored by U.S. Rep. Earl L. “Buddy” Carter, R-Ga., would amend the American Taxpayer Relief Act of 2012 to delay inclusion of the binders until 2033.
“Ensuing that the pending inclusion of oral-only drugs in the [End-Stage Renal Disease] Prospective Payment System (PPS) bundle meets the needs of the ESRD community is a priority for Kidney Care Partners, so we’re encouraged by the recent activity in the House of Representatives on this policy,” Mahesh Krishnan, MD, MPH, MBA, FASN, chair of Kidney Care Partners (KCP), told Healio.
“Without congressional action, this harmful policy would exacerbate the challenges the kidney community already faces, including diminished access to innovative therapies, insufficient reimbursement and limited or nonexistent choice of insurance coverage for patients,” KCP, a kidney community advocacy group, said in a press release.
According to language in the bill, placement of oral drugs indicated for the “reduction, management or control of the serum phosphate of an individual” would be delayed until 2033 unless “an intravenous drug indicated for the reduction, management or control of the serum phosphate of an individual has been approved by the [FDA].”
The General Accounting Office (GAO) released a report last November reviewing plans by CMS to include oral phosphate binders in the PPS by 2025. The report notes that dialysis organizations interviewed by the GAO “expressed concerns that the modified bundled payment may not fully account for the costs of acquiring, shipping and dispensing phosphate binders.”
References:
1 min read
SAVE
Legislation pushes for a delay in placing phosphate binders in the ESRD payment bundle
Add topic to email alerts
Key takeaways:
The Kidney Patient Act would delay placement of oral phosphate binders into the dialysis payment bundle.
Binders would be placed in the bundle if an injectable version receives FDA approval.
Congress is reviewing legislation that would delay inclusion of oral phosphate binders into the End-Stage Renal Disease Prospective Payment System bundled payment system.
NNI0324Carter_Graphic_01
CMS currently has plans to include oral binders in the bundle by Jan. 1, 2025, but the Kidney Patient Act (H.R. 5074), sponsored by U.S. Rep. Earl L. “Buddy” Carter, R-Ga., would amend the American Taxpayer Relief Act of 2012 to delay inclusion of the binders until 2033.
“Ensuing that the pending inclusion of oral-only drugs in the [End-Stage Renal Disease] Prospective Payment System (PPS) bundle meets the needs of the ESRD community is a priority for Kidney Care Partners, so we’re encouraged by the recent activity in the House of Representatives on this policy,” Mahesh Krishnan, MD, MPH, MBA, FASN, chair of Kidney Care Partners (KCP), told Healio.
“Without congressional action, this harmful policy would exacerbate the challenges the kidney community already faces, including diminished access to innovative therapies, insufficient reimbursement and limited or nonexistent choice of insurance coverage for patients,” KCP, a kidney community advocacy group, said in a press release.
According to language in the bill, placement of oral drugs indicated for the “reduction, management or control of the serum phosphate of an individual” would be delayed until 2033 unless “an intravenous drug indicated for the reduction, management or control of the serum phosphate of an individual has been approved by the [FDA].”
The General Accounting Office (GAO) released a report last November reviewing plans by CMS to include oral phosphate binders in the PPS by 2025. The report notes that dialysis organizations interviewed by the GAO “expressed concerns that the modified bundled payment may not fully account for the costs of acquiring, shipping and dispensing phosphate binders.”
References:
ChatGPT 's answer
Nantahala Capital active in UNCY , RZLT and SLNO
In UNCY. increased their position from 1,207,416 shares to 3,475,713 on 2/14
Kiwi
This is a new position for Nantahala Capital ....4,118,164 shares
Kiwi
March 11 (Reuters) - Rezolute Inc ( RZLT ):
* NANTAHALA CAPITAL MANAGEMENT LLC REPORTS 9.9% PASSIVE STAKE IN REZOLUTE INC AS OF AS OF FEB 29 - SEC FILING Source text for Eikon: Further company coverage:
Kiwi
RMB. not sure as I haven't seen a detailed description on the trial design like we saw with AMRN's MITIGATE .
Some key pts .
This final trial is not about efficacy . The FDA has already accepted that OLC is the bioequivelant of Fosrenol . Fosrenol is powder or large chewable pills. OLC is a smaller " condensed " version.
The final trial ...with dialysis patients ...is only about tolerability.
The earlier trial showed that while the side effects were the same for Fosrenol and OLC ...there were more of them reported for those trying OLC .
So in the real world ....does this make a difference in patient compliance .
On Fosrenol they have to chew the pills ( or mix the powder with applesauce ) with each meal . Patients hate chewing the pills .
On OLC they can swallow 1 small pill per meal ......but may experience more side effects ( will attach what those are later ) . So will the patients put up with more side effects ...which may diminish over time ...if they can swallow the smaller pills instead of chewing the larger pills.
So they are enrolling 90 . Some will drop out or miss the occasional pill. Hopefully at least 60 will take all the pills as directed ......except for those that stop because they are experiencing side effects they don't want to try and tolerate.
The perfect outcome is for at least 60 to take all the pills as directed for the entire time of the trial...with no dropouts due to side effects
Kiwi
RMB. they are enrolling up to 90 in the trial with aiming having 60 to evaluate
RMB ...comparing RZLT and EYEN ...a quick Look.
Last earnings report EYEN had $21m cash and were losing $7.3 m a qt ....so you know a huge capital raise is coming if they hope to manufacture and sell their device
RZLT has $96m in cash and are losing $14m a qt ...so their cash on hand will last them well into 2025 ...altho they will probably raise $ on a good DME trial read out ...late May I think .
I'm biased to Bay Area biotechs as I've met people working at some of them and hedge fund managers that invest in them .
They are usually connected to leading edge KOL's at places like Stanford and UCSF and often have them on their advisory boards , even BOD's.
Chk TNYA for instance ( which I also own ...early days )
Good luck
Kiwi
RMB. well there are at least 3 things going on .
1) the MD's awareness of the drug and willingness to prescribe
2) prior authorizations the insurer may set up first ... eg just try driving LDL lower etc
3) Co pays and the willingness of patients to pay.
There have been cases where my wife will not prescribe certain drugs for her CKD patients until the head of the Renal dept OK's it .
The fairly new drug for high serum potassium for instance . Head of Dept would not OK until he did a deep dive at a conference .
Now , a year or so after FDA approval ...she prescribes it.
She's also prescribed Vascepa .... patient couldn't afford , or was unwilling to pay the copay
And Dr Ralphey can tell you all about prior authorizations ...when he was prescribing V .
If you really want to see an uptake in V scrips .. brand or generic ...drum roll please ...have an independent Co / health care provider run a new trial on a sub section of R-IT ...say secondary prevention diabetics in US patients ....to independently confirm US R-IT .
By the way UNCY's pivotal trial is now fully enrolled ...data late Q2
Kiwi
Trial now fully enrolled ..reported AH today
Data late Q2
Unusual AH action ...ran up to $2 which is what I expected ...but then sold off ...capital raise ???
Kiwi
Re PFE. Josh Brown was on CNBC yesterday saying he was buying PFE . Reasons he gave were ...Low risk at these levels , lot of talent in Co etc so he was prepared to buy at these levels and just hold for a year .
Kiwi
HC Wainwright & Co. analyst Ed Arce reiterates Unicycive Therapeutics ( UNCY ) with a Buy and maintains $4.5 price target.
Kiwi
A little note about life expectancy for those on dialysis
Comments ..yeah. Thank you Dew for providing a forum for investors like Mufaso to present their DD ...so the rest of us can all learn and benefit from.
Much appreciated
Kiwi
GD. Well it will be a big deal if they see clinical benefit in DME . I'm also in OCUL ..drug eluting inserts , and you're in EYPT ...injections ( but longer duration between shots ? )
If U have time take a look at UNCY. My wife rounds dialysis clinics ( also did CKD research at Yale ). None of her patients are at goal for serum phosphorous.....and none can afford the copay for the new serum phosphorous lower drug ...Xphanozh ? ...unless co ( ARDX ) pays down their copay ( currently $1,000 a mth ) .
The clinical data for OLC ( UNCY ) looks impressive . Co has also just been granted Orphan Drug designation .
However Co has limited cash and looks to need a capital raise to complete their current pivotal trial .
So if you have time , take a look ...let me know if you see any red flags I'm blind to .
Kiwi
Comments from the board ?? My comment ..In Mufaso we trust . ...Gr8 DD
Thx
Kiwi
RMB. The P2 DME trial is probably a long shot to show clinically relevant improvement . Dew ( biotech values ) was of the opinion that there was a narrow therapeutic window ( which means I think that at high enough dose to see clinically relevant benefit , you'll probably see a lot more side effects .)
I'm hopefully tho because of the involvement of this KOL ...Robert B Bhisikul MD ..UCSF Prof of Ophthalmology and Retinal Specialist .
UCSF are cutting edge ...I was in a Cardiovascular trial their years ago
RMB. Another trial I'm following is the RZLT P2 trial in DME . Results due around when I expects UNCY's trial results
Chk out the RZLT board and leave a comment if interested
Kiwi
P2 DME trial is fully enrolled with primary completion in April ..results probably in late May
https://www.clinicaltrials.gov/study/NCT05712720?tab=history&a=7
About RZ402
RZ402 is a selective and potent PKI being developed as a potential once-daily oral therapy for the chronic treatment of DME. By inhibiting the activation of kallikrein, RZ402 is designed to block bradykinin production and its resulting effects on vascular leakage and inflammation.
RZ402 has been shown to reduce and prevent retinal vascular leakage in animal models by up to 90%. Results from a Phase 1b multiple ascending dose (MAD) study showed that RZ402 was readily bioavailable with dose-dependent increases in systemic exposures.
RZ402 concentrations substantially exceeded target efficacious concentrations based on a combination of in-vitro and in-vivo pharmacology studies in animals, supporting the potential as a once daily therapy for DME.
RZ402 was generally safe and well-tolerated, including at higher doses than previously tested in the single ascending dose (SAD) study.
There were no serious adverse events, adverse drug reactions, or identified risks.
Kiwi
Downtownguy. No I'm not related to Ralphey and agree with most of what you have just posted.
I think his posting behavior is totally inappropriate for some one who is also an MD .
JMO
Kiwi
More on the Orphan Drug designation
https://www.fool.com/investing/2020/10/04/what-you-need-to-know-about-orphan-drug-designatio/
Kiwi
RMB. my guess is that they won't finish their final pivotal trial in Q2 ...because of the increase in numbers to be enrolled ...more like Q3 .
They may get a hedge fund to do a private placement as no sign so far of a public raise .
Intense story about your mom . Hope all ended well .
Re Kiwi .....It goes back to the ANZAC's of WWI or WW2 ...to differentiate us ( New Zealanders ) from the Aussie's ( Australians ) ...as we were ( in English commanders eyes ) ...rough colonials.
I don't consider it derogatory ...so no worries
I was interested in why Cerevelo's kidneys shut down ...was it for reasons similar to your mom's heart procedure ...and what meds he was on now ?
Another Co I follow has a drug in trials to reduce risk of kidneys shutting down during surgery ...cant remember which one right now .
In the kidney space I also own VERA ..suggest you follow them ...functional cure for IgAN . Most who develop IgAN kidney disease in their 40's will need a new kidney or dialysis in their life time . VERA's drug is the first / only drug so far , to change that ...enable those with IgAN to retain kidney function . The rest just slow the decline.
UNCY mgt certainly needs to update us investors re any change in trial time line .
Kiwi
RMB. I added some back in on the Orphan drug designation. I still think they need to raise cash to fund completion of their pivotal trial ...but this new designation should help them raise funds on better terms.
JMO
Kiwi
Cervelo Sorry to hear you spent a year on dialysis and glad to hear you recovered kidney function .
Can U share what caused your loss of kidney function and what meds you are on now. ?
A good friend of mine had a coronary bypass and the contrast used crashed his kidneys . Resulted in him being on dialysis and in the ICU for 10 days .
Good luck
Kiwi
Re UNCY. Orphan drug designation
Orphan drug designation
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=990223
The present invention relates to the synthesis and application of novel chiral/ achiral substituted methyl formyl reagents to modify pharmaceutical agents and/or biologically active substances to modify the physicochemical, biological and/or pharmacokinetic properties of the resulting compounds from the unmodified original agent.
Kiwi
JR. This is how things run in China ...from 2018 govt decree .
JR while I agree with most of your posts ...Vascepa in China will only be for the very wealthy who will pay for highest EPA quality themselves.
The vast majority of the population that might benefit..... will be directed to low cost similars .
Theres a reason many US Co's have withdrawn from China .....I'm sure you'll work out why .
JMO
Kiwi
Thx. Got stopped out of half of my UNCY position . With 90 patients to enroll now ( not 60 as per original design ) this Co needs to raise cash to complete the trial and release results ...probably in Q3 now ...not Q2 as claimed in most recent PR
JMO
Kiwi
No sign of a capital raise. The selloff may have just been due to its high RSI reading . Some traders just sell once a stock is trading above 80 on the RSI ,,,or set stops close in case theres a large sell order . Then stop loss' s get triggered in a step down fashion.
I think the RSI got as high as 87 ...highest in a year
Kiwi
ps
I own / owned some VKTX ...nice day to wake up to
Congrats Mufaso. Thx for all your excellent DD
Kiwi
Re OCUL Thx for that link
Kiwi
Reasons for sell off ...my guess ...a capital raise as now they are enrolling 90 patients so pivotal trial will take longer and burn $.
2nd guess ...but less likely ...patent challenge
I added 10 min before close. Enrolling more , increasing power etc are good things . That this trial will now cost more should be expected. If Co raises $ they will add just enough to fully fund trial and readout
JMO
Kiwi
Reasons for increasing the trial size ...from ChatGPT
RMB. thx for the link. IMHO the trial size was increased to increase " powering " .
I'll try and find a link that explains powering in clinical trial ....but bottom line IMHO it's great they have increased to the trial size .
Downside is that the trial will now take longer and cost more ...but the result ( what ever it is ) will have a higher probability of being accurate / less due to chance .
The end point is " How many stop taking OLC over a 4 wk period ...for whatever reason ".
Kiwi
DAR53. This is the latest Real World Data ( something I'd like to see on Vascepa ) regarding using IVL for calcified coronary plaques. There are instances where stents are not inserted because the interventionist fears they can not be deployed properly .You might consider passing this on if you feel appropriate.
https://www.jacc.org/doi/10.1016/j.jcin.2023.12.018