Whalatane
1 week ago
It could be close ...assuming they file by end of Aug /24
The standard PDUFA goal for reviewing a non-priority New Drug Application (NDA) without a new molecular entity is 10 months.
For priority review NDAs, the PDUFA goal is 4 months shorter than for standard review, which would be 6 months.
NDAs involving a new molecular entity have a PDUFA goal that is 2 months longer than those without one.
An analysis of 637 NDAs submitted from fiscal years 2014 through 2018 found that the average time from submission to approval was 273.8 days, which is approximately 9 months.
The FDA is required by law to review NDAs within 180 days (about 6 months) of filing, but this deadline is often exceeded.
The actual review times can vary significantly based on several factors, including:
Whether the drug qualifies for priority review
If it contains a new molecular entity
If the applicant submits a major amendment during review
How many expedited programs the drug qualifies for
Different FDA divisions may have slightly different average review times, with most being within 2 weeks of each other, though some divisions like hematology and oncology tend to review applications 2-3 weeks faster than others.
AI generated
Kiwi
Whalatane
2 weeks ago
RMB. Yep I'm holding what remaining shares I have also.
From a recent Nephrology update
Another company called Unicycive has developed lanthanum dioxycarbonate. And this is a pill, but it's much more potent and doesn't need to be chewed up to be activated. It's kind of microparticles. And at least in preliminary studies, it looks like it's probably about 40% more potent than our most potent binder right now, which is Velphoro (sucroferric oxyhydroxide, Fresenius Medical Care North America). And conceivably, this would lead to 70% to 80% of patients could literally take just one pill with each meal and have adequate phosphorus control, at least less than 5.5 mg/dL. And that's kind of exciting. I think we need more potent phosphate binders.
So here we have a drug that some Nephrologists are excited about .......and the Co thats preparing the data for FDA approval ...tanks
Dilution , fraud , qtly report delayed ...all 3 ??
A H/T to FFS .... never ignore the chart action
Kiwi
Whalatane
2 weeks ago
Mr Mister so some thoughts on your post
The largest number of warrants were issued with the IPO and their exercise price ( from what I could find ) is $6 .....so no risk of them being exercised anytime soon.
The Co still has around $28m cash left now ...no trials to run and can run their co on minimal staff for the FDA filings .
In their Aug 1 presser
• Expect to capitalize on CMS plan to expand patient access to phosphate binders in 2025
- Minimum 2 years of separate Medicare Part B payment (Transitional Drug Add-On Payment Adjustment – TDAPA) for new drugs at 100% of average selling price
So when approved they will go the TDAPA route ( unlike ARDX ) and can get full coverage for 2 yrs ...with the potential upside of the Kidney Patient Act passing and thus more market access when the TDAPA period ends.
There is patient demand IMHO for this drug ...will be less expensive then Xphazoh and far lower pill burden for those on the current binders .
Those already on Fosrenol should be OK with the transition to OLC .
However I doubt more than 20% of the dialysis population will use OLC since many are on Medicare / Medicaid and eventually won't be able to use any company coupon to lower the expected copay.
The risks
They may need more money ... very likely
They will need to do a reverse split probably by mid 2025 unless they are miraculously able to get the PPS over $1 for 10 days
In a risk off environment we are in now ...why have $ tied up in something that may be 2 yrs away from generating any significant $
The outside surprise ...very cheap at these levels for a BP in the kidney field to buy out .
Raising $ by selling overseas rights in the UK or EU or Japan
JMO ...I had reduced my position due to the price action ...but will keep some just to see how this ends up .
Kiwi
Unicycive Therapeutics, Inc. has issued several series of warrants, primarily associated with their Preferred Stock Offerings. The details of these warrants are as follows:
Series A-3 Preferred Stock Warrants:
Number of warrant shares: 47,852,430.
Initially recognized at fair value and subject to remeasurement.
Series A-4 Preferred Stock Warrants:
Number of warrant shares: 43,502,206.
Initially recognized at fair value and subject to remeasurement.
Series A-5 Preferred Stock Warrants:
Number of warrant shares: 69,603,531.
Initially recognized at fair value and subject to remeasurement.
The warrants are measured at fair value using unobservable inputs and are classified as Level 3 inputs. The valuation involves complex models such as the Black Scholes model and Monte Carlo simulation techniques, considering factors like exercise price, underlying stock price, expected volatility, risk-free rate, and probability assumptions related to shareholder approvals and technical milestones.
Whalatane
3 weeks ago
From Ernie on the ARDX board ...Nephrologist interview mentioning ARDX and UNCY
Editor’s note: This is an automatically generated transcript. Please notify iwaters@healio.com if there are concerns regarding accuracy of the transcription.
Going back to the tenapanor drug, I'm interested in seeing further studies of how we optimally combine this with phosphate binders. It's a twice-a-day drug, which technically doesn't have to be taken with meals, although in the trials, they tended to give it with the meal. The expectation is that we would combine it with phosphate binders. There's a recent publication by a Japanese group doing that, and they lowered the phosphorus substantially in people who were on binders, but not achieving goal. And they increased the proportion of patients getting to a phosphorus of less than, I think they wanted, less than 6 [mg/dL] from 30% with the placebo pill to about 70% of the patients who added the tenapanor to their binder. So that's really exciting. The next is a drug, which just has a code name, EOS789, which is a pan-phosphate inhibitor. It inhibits NaPi2b and two [inorganic phosphate] PiT transporters, which are all phosphate transporters in the gut. This agent, in at least a phase 1 study, did seem to be pretty effective at lowering the proportion of phosphorus absorbed in meals. We're going to need a lot more data on how tolerable it is and how efficient it really is in improving phosphorus in hemo[dialysis] patients going forward.
And then the third agent is a phosphate binder of the lanthanum type. So, we already have lanthanum carbonate. It’s a pretty potent drug. [There are] a lot of problems with the GI side effects, and the pills are extremely hard and have to be chewed thoroughly or crushed in order to be effective. Another company called Unicycive has developed lanthanum dioxycarbonate. And this is a pill, but it's much more potent and doesn't need to be chewed up to be activated. It's kind of microparticles. And at least in preliminary studies, it looks like it's probably about 40% more potent than our most potent binder right now, which is Velphoro (sucroferric oxyhydroxide, Fresenius Medical Care North America). And conceivably, this would lead to 70% to 80% of patients could literally take just one pill with each meal and have adequate phosphorus control, at least less than 5.5 mg/dL. And that's kind of exciting. I think we need more potent phosphate binders.
Kiwi
Whalatane
4 weeks ago
Opinion by Dew who I think is ex Harvard Med
Member Level
Re: Whalatane post# 252682
Thursday, July 25, 2024 10:04:04 PM
Post# of 252696
ARDX/UNCY—As noted earlier, the reversal of the "Chevron" doctrine by the US Supreme Court should give the plaintiffs in this case a decent chance of prevailing, IMO. Absent the reversal of Chevron, the lawsuit probably would not have been filed.
The reversal of the Chevron doctrine has received a lot of criticism from various parties, but here we have a case where two (arguably) deserving drug companies are clear beneficiaries.
So I think UNCY has the most upside should ARDX prevail against the CMS as Dew expects .
ARDX is spending the legal $ ...UNCY gets to ride along for free
Should ARDX prevail ....Both ARDX and UNCY will have niche markets since they are competing against generics ...however UNCY's OLC is more effective at lowering serum pho and is likely to be less expensive ...so any legal win is likely to be a huge plus for UNCY .
JMO
Kiwi
Whalatane
1 month ago
Minority groups lining up to support the Kidney Patient Act ...which is good for UNCY when they get OLC approved
The National Minority Quality Forum, a health care research, education and advocacy organization, has joined a lawsuit against CMS to prevent the inclusion of oral phosphate-lowering therapies in the ESRD bundled payment.
The American Association of Kidney Patients (AAKP) is also part of this lawsuit. While not exclusively a minority group, AAKP advocates for all kidney patients, including minority populations who are disproportionately affected by kidney disease.
The Sickle Cell Disease Association of America supports keeping phosphate-lowering drugs out of the ESRD bundle. They note that 1 in 3 adults living with Sickle Cell Disease has chronic kidney disease, and keeping these drugs out of the bundle allows doctors and patients more control over their care regimen.
The National Consumers League, which advocates for patient-centered health care, expresses concern that changes in Medicare coverage will cause kidney patients to lose access to quality care and innovative treatments. This is likely to disproportionately affect minority patients.
Dr. Frita McRae Fisher, a nephrologist, argues that including phosphate-lowering therapies in the bundle would disproportionately affect Black patients, who make up more than 35% of dialysis patients but only 13.2% of the U.S. population.
Kiwi
Whalatane
1 month ago
The dialysis bundle explained and its relevance to UNCY ( and ARDX )
The dialysis bundle in the United States is a comprehensive payment system implemented by Medicare for end-stage renal disease (ESRD) treatment. Here's an explanation of the key aspects:
Purpose and Implementation:
The dialysis bundle, officially known as the End Stage Renal Disease (ESRD) Prospective Payment System (PPS), was implemented on January 1, 2011. Its purpose is to provide a single, bundled payment to dialysis facilities for renal dialysis services provided to Medicare beneficiaries.
What's Included in the Bundle:
The bundled per-treatment payment covers:
Dialysis treatment
Drugs and injectable medications
Laboratory services
Supplies
Capital-related costs
Equipment and supplies used for home dialysis
Oral drugs with injectable equivalents
Payment Structure:
The payment is made on a per-treatment basis and is adjusted for patient-level and facility-level factors. It includes provisions for:
A base rate
Adjustments for patient demographics and comorbidities
Quality incentives through the Medicare Quality Improvement Program (QIP)
Oral-Only Drugs:
Currently, oral-only drugs (those without injectable equivalents) are not included in the bundle. However, CMS plans to incorporate these, specifically phosphate binders, into the bundled payment starting January 1, 2025.
Innovative Treatments:
The system includes provisions for new treatments:
Transitional Drug Add-on Payment Adjustment (TDAPA) for new renal dialysis drugs and biologicals
Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES)
Impact on Clinical Care:
The bundled payment system has led to changes in clinical algorithms and quality improvement activities. For example, Fresenius Kidney Care reported optimizing the use of erythropoiesis-stimulating agents (ESAs) and vitamin D treatments while maintaining or improving quality outcomes.
Quality Metrics:
The bundle is tied to quality metrics through the QIP, which examines factors such as dialysis adequacy and management of complications like hypercalcemia.
Drug Designation Process:
CMS uses a drug designation process to determine how new renal dialysis drugs and biological products are incorporated into the bundled payment.
The dialysis bundle aims to incentivize efficient care delivery while maintaining or improving quality outcomes for ESRD patients. It has led to changes in clinical practices and resource allocation within dialysis facilities, with ongoing adjustments to incorporate new treatments and medications into the payment system.
Note high lighted area .
If included in the bundle , price caps would limit any use of OLC ( UNCY ) or Xphazoh (ARDX )
Outside the bundle the MD can get Medicare to cover 75% of the cost and the Co can issue coupons to reduce the copay to the patient
Kiwi
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