Unicycive Therapeutics Inc (UNCY)

Thanks I thought they were double dipping but you, Denisk and Gemini cleared that up

Denisk ...good catch
There are no new RSUs issued today (June 15, 2026).
The most recent corporate filings show that Unicycive Therapeutics' last major disclosure was a Form 8-K submitted on June 5, 2026.

The confusion likely stems from the vesting schedule of the May grant rather than a new issuance.

Here is how the timeline connects to today:
Why "Today" Matters to the May Grant
The May Filing Was a Correction:
The amended Form 4/A filed on May 14, 2026, was a formal correction to fix reporting errors regarding the exact number of shares granted to executive leadership.

The Monthly Vesting Has Begun:
No new shares were added today, but the 21,172 incremental shares from that corrected May grant are actively in their monthly vesting cycle.
If you are tracking an internal equity account or brokerage statement that updated today, it is reflecting the distribution or processing of those previously approved May shares, not a new dilutive corporate action.

With an assist from Gemini ( looking at the CEO's RSU's )
Kiwi
PS. sorry Ernie :--)

If you look these are amendments to previously issued shares on May 20 2026

If you look these are amendments to previously issued shares on May 20 2026

😂😂 🤞

Easy there Ernie….maybe it’s there way of making them instant millionaires like space x 🤔

Options at ZERO cost to each insider - FOR WHAT? they already get a salary and from what I've seen they don't really do a damn thing besides collect undeserved options and RSUs

Just venting

Lots of form 4 filing alerts after hours 6-7 of them insiders adding or buying

Currently down 14 cents but don’t worry after market and pre market tomorrow we’ll be up a lot …..rinse and repeat 🤮🤯

What was that sudden 5% bump? Institution coming into the scene?

Agree I'm wondering if we get this class action law suit settled by court day ( this Thursday ) . It's a distraction . Would be good to get rid of it at a reasonable price rather than deal with discovery ( and the costs involved ) if it proceeds.
JMO
Kiwi

You definitely have set out 3 possibilities after hopefully FDA approval.  Just hope we get approval and make the TDAPA cutoff. The rest will then take care of itself. 

I stand corrected

I generally ignore analyst price targets at this stage .
So we get approval but miss the July qt cut off for TDAPA application ...whats the target then .
We get approval , file for TDAPA on time and CSL Vifor makes a licensing offer ( which I expect ) for OLC ...whats your price target then .
Congress decides to approve the Kidney Patient act ...increasing 100% reimbursement for Medicare patients to 3 yrs from the current 2 ...whats your PPS then ...especially since Velphoro will now have another year in TDAPA
ETC .
U feeling better about RZLT now ??? ...just checking in :--)

Kiwi

I think that is rainbows instead of roses - Leslie Gore.

Sunshine, lollipops and roses

With the average price target at $41, what are they modeling in currently?

It's critical they file immediately on approval to make the July Qt cut off date . So assuming they get approved by / on June 29th and file on time ...the whole process can take 6 mths before the TDAPA pricing / reimbursement kicks in.

Analysts will model this in well before the 6 mths are up and I expect CSL Vifor to get serious about licensing ( at least ) OLC for the Fresenius clinics soon after approval

Just my best guess . This is a high risk investment

If the class action lawsuit is not settled this week ..PPS could take a small hit as it means higher legal spend unless case is dismissed

Kiwi

Thanks. How long do you expect it to take to get approval, or to hear back on TDAPA? I’ve heard it can take around six months. Do you reckon that’s realistic?

I AGREEEE

Well memory chip stocks ..or ETF's like DRAM are sucking $ from everywhere ..especially very risk biotechs awaiting an FDA decision .
Why risk a biotech when demand for memory chips is so clearly telegraphed for the next few years .
JMO
Kiwi

Pattern continues - UP in pre-market and then crashes to the negative after open

While profit taking " sell the news " is common immediately on approval ...if this drops to $5 * which I dont expect ) ...then I'm adding
From AI
Securing a spot in the Transitional Drug Add-On Payment Adjustment (TDAPA) program for 2027 is the single most critical catalyst for Unicycive’s (NASDAQ: UNCY) post-approval valuation.
It effectively neutralizes the traditional "commercialization chasm" that usually crashes small-cap biotech stocks.

If Oxylanthanum Carbonate (OLC) is approved in June 2026, a guaranteed TDAPA designation for January 2027 will act as a powerful upward re-rating driver for the stock price throughout late 2026 and 2027.

1. Eliminates the "Launch Lag" (De-risks Revenue)Normally, when a small biotech approves a drug, the stock drops because Wall Street knows it takes 12–18 months to negotiate with insurance companies for coverage.

The TDAPA Effect:
Under the Centers for Medicare & Medicaid Services (CMS) rules, TDAPA allows new renal drugs to bypass the restrictive "dialysis bundle" entirely.

Stock Impact:
Instead of waiting years for revenue, UNCY can launch immediately into a predictable, fully reimbursed market. Wall Street analysts will dramatically ramp up their 2027 revenue models, pulling future cash flows into the present valuation and driving the stock price up.

2. Dictates Premium Pricing
(ASP + $36.41)Phosphate binders are a massive financial burden on dialysis clinics, and clinics usually reject expensive new drugs in favor of cheap generics.

The TDAPA Effect:
CMS pays for TDAPA phosphate binders at 100% of the Average Sales Price (ASP) plus a specialized $36.41 add-on per treatment.

Stock Impact:
This ensures UNCY can command premium pricing without driving dialysis clinics away.
Higher profit margins per patient mean a significantly higher peak-sales valuation for the company, pushing equity research price targets upward.

3. Institutional "De-risking" and Capital Inflow
Large institutional biotech funds generally avoid clinical-stage companies because of regulatory risk, and they avoid early-stage commercial companies because of commercial execution risk.

The TDAPA Effect:
TDAPA provides a two-to-three-year guaranteed government runway where Medicare picks up the bill for the drug.

Stock Impact:
This certainty transforms UNCY from a speculative gamble into a highly quantifiable commercial growth story. Large funds will feel comfortable buying shares, creating sustained institutional buying pressure that drives the stock price higher

.4. Mitigates the Dilution Shock
As established, a primary reason drug stocks trade lower immediately after approval is the fear of a massive, dilutive secondary stock offering to fund the sales team.

The TDAPA Effect:
Because TDAPA guarantees immediate reimbursement and high adoption momentum from clinics, UNCY’s need to bleed cash on commercial infrastructure is heavily mitigated

.Stock Impact:
If UNCY does raise capital post-approval, they will be doing so from a position of commercial strength rather than desperation. Investors tolerate dilution much better when it directly funds rapid, high-margin revenue growth.


There will be warrants exercised on approval which usually dilutes PPS ...but this is well known and should be priced in
JMO
Kiwi

2 weeks to the biggest day in the company's history and they haven't said a word in 10 days? Management is committing malpractice IMO

Guppy

Hi Kiwi, thanks a lot. Really appreciate your view.

My frustration is mainly with management, not the product. I think the recent weakness started when Shilpa’s Q1 update mentioned the manufacturing expansion/new line, and UNCY should have been much more careful about how that wording landed with investors.

Even now, a small update on ongoing partnership discussions, TDAPA plans, or launch readiness could help rebuild confidence. Sadly, they’ve stayed too quiet, and that silence is letting doubt grow.

Just my thoughts.

Good reason to avoid Stocktwits . The idea that at the current price , approval is priced in is absurd IMHO and shows complete ignorance as to how the TDAPA economics work ...see previous posts especially my last to poster Fred. .
As regards ARDX......Xphozah .
Most of my wife's patients that have tried Xphozah can't get past the diarrhea phase , common in the first 2 weeks . As one patient said to her " I can take Xphozah or I can come to dialysis ...I can't do both " .
Most dialysis patients complain about constipation . So an ideal combination would be 1 cap of Xphozah in the AM , then OLC at lunch and dinner .
Not only would that be the most patient friendly , but also the most effective in reducing serum pho . .

Suggest you read up on the mechanics of TDAPA and why the launch of OLC and TDAPA coverage in 2027 , makes UNCY different from normal drug launch into a field dominated by generics .

JMO and I can be wrong ...have been before ...so do your own DD , ignore Stocktwits and risk what you can afford to lose .
If we get another CRL the PPS will be cut in half ..at least ...so dont say you haven't been warned

Kiwi

Not really sure how to rebut that opinion or concern on ST but I did have one thought that came into my head and here it is.

Obviously analysts not only can be massively wrong from time to time but they also may have ulterior motives for their calls and targets. Having said that, looking at analyst targets, I see the average target at $41 and lowest target at $18. We have to remember that a year ago plus 5 days UNCY had a 1 for 10 Reverse stock split. So right now we are still below 80 cents based on the pre-split price. Anything can happen of course, but if the stock price stays at this level going into approval, I would assume that even a sell the news wouldn't drop it much - heck we were in the mid - sixes just days ago, so the $5's almost there. If there is a huge runup like into the low teens, I will definitely take some off the table.

$UNCY risky play here. The approval may be priced in. If retail, swing traders won't get an expected pump/run on approval news the masisve rug pull may occure taking it to mid $5's just personal opinion. I have seen this before on other bios. Holding for $12 myself.

Seeing more bearish posts now on stocktwits, especially from ARDX supporters, and I’m trying to separate genuine risk from fear-driven noise.

The “approval priced in, rug pull to mid-$5s” scenario is possible in biotech, but I’m not sure it’s the base case here. Just trying to stay realistic without getting shaken out by StockTwits sentiment.

The "staying up" is important to me as this is one stock that at least in some of my accounts I don't intend to sell upon the news of approval. GLTA

We got two weeks to go…let’s get this sp going up and staying up….remember it was at $11 pre rs last year about this time …..

None of the following sources are from IHUB or other investor type forums ...beyond their link to actual UNCY news release

If UNCY's OLC is approved in 2026 and enters TDAPA in 2027 ...are the major dialysis providers incentivized to use it because it may be the only binder with 100% Medicare reimbursement ?

From AI

Probably yes, but not automatically. If OLC is approved and gets TDAPA, dialysis providers would have a strong reimbursement reason to adopt it during the TDAPA window because Medicare would pay separately for the drug rather than forcing the cost into the dialysis bundle.

Why that matters
TDAPA is designed to support early access to new dialysis drugs, and for eligible new renal dialysis drugs it has been paid at 100% of ASP for a limited period. That means providers are much less exposed to immediate margin risk when starting the drug.

Why adoption still may not be guaranteed
Providers do not choose drugs on reimbursement alone. They also consider clinical benefit, operational simplicity, formulary preferences, payer mix, and whether the drug creates future financial winners and losers once TDAPA ends. A source discussing dialysis-drug uptake notes that if reimbursement after the add-on period becomes fractional across the patient base, rational providers may hesitate to adopt a new drug broadly.

For OLC specifically
Unicycive has said OLC is an oral phosphate binder for patients with CKD on dialysis and that it is preparing for a potential launch. CMS materials also indicate that oral-only dialysis drugs are being incorporated into the ESRD bundle, which makes the separate-payment period especially important for new products like OLC.

Practical takeaway
So the better answer is:
TDAPA should create a meaningful incentive for major dialysis providers to use OLC early, because it reduces reimbursement risk and may temporarily offer the closest thing to full Medicare payment.

But whether it becomes broadly adopted will still depend on how it compares with existing binders clinically and economically, and on how providers expect payment to look after TDAPA ends.

List the sources for this opinion
The sources behind that opinion were:

Unicycive’s investor release saying the FDA accepted OLC’s NDA resubmission and that the company is pursuing approval.

A 2026 Unicycive investor update stating FDA review of OLC’s resubmission was on track.

A CMS/ESRD PPS overview explaining how TDAPA works and that it supports access to new dialysis therapies.

A CMS-related 2025 ESRD PPS update describing TDAPA treatment for phosphate binders and the add-on period.

A 2025 article on the ESRD payment system discussing how bundling can reduce uptake of new dialysis drugs.

A 2025 review article on dialysis care and the ESRD PPS discussing broader payment incentives and innovation.

---------------------
Kiwi

Possibly. I’m just trying to understand the recent weakness better. Do you think it’s mainly low-volume manipulation, or genuine commercialisation concern ahead of PDUFA? Also curious what you expect over the next few weeks and. Any fresh perspective would be appreciated! Thanks in advance

This litigation has very little impact on the share price IMHO.

These AI research results are often just reiterations of thoughts we see here on ihub and other forums.

RMB one of the emails I got from there IR guy said the tdapa is ready to go once they get fda approval….and this can be sent electronically…..shouldn’t be a problem then from what I was told

First up , remember
The motion to dismiss in Hamza Elkhodari v. Unicycive Therapeutics, Inc., et al. (Case # 3:25-cv-06923) will be heard on Thursday, June 18, 2026, at 11:00 AM..
We obviously want this dismissed or settled .
If its not settled before /on court date and is allowed to go to discovery ....UNCY runs the risk of running up a legal bill into the millions .
The judge may take several weeks before issuing a decision on dismissal vs continuation . If he / she decided continue ...the cost of settlement goes way up.

Once approved ...hopefully by /on June 29th , I expect UNCY to do a " soft " launch ...basically samples out through DaVita and Fresenius ....while UNCY engages in licensing discussions .
As you know ...I dont want UNCY to go it alone . I'm concerned they may repeat AMRN per 2013 after approval of the Marine indication ( for U AMRN veterans ) ...where by Co spent 3-4 mths trying to partner or sell the rights to what known now as Vascepa ...only to go it alone late in the year ...and the stock dropped by 1/3rd. .

Because CSL Vifor / Fresenius own Velphoro they can really slow walk OLC use if they want to in the Fresenius clinics ...until the TDAPA economics over whelm them ( see previous posts ) ...forcing UNCY to burn thru thru cash in second half of 2026. .

Ceo's have ego's and since our Ceo has been promoting himself in Bloomberg ads ..he may want to try and have UNCY do the full launch in 2027 themselves .
Hopefully the hedge funds ...major players here in stock ownership ...will force action thats best in their and our interests .
JMO
Kiwi

Well the only thing about the market pricing in a sell-the-news risk, is that should prevent a sell-the-news event if already priced in.  But of course that still means not much of an increase in price upon approval.  Investors may be more sophisticated and might be waiting to see if and when OLC gets TDAPA entry.  

Thanks guys, special thanks to Kiwi, really appreciate your reply. I’m not saying the thesis is broken or that approval has no value, but I’m just sharing where my head is at. The stock action lately has made me a bit more cautious. A month ago this felt like a very solid setup, but now I’m wondering whether the market is pricing in sell-the-news risk, dilution worries, or just low confidence before the PDUFA.

Maybe I’m overthinking it, but my main fear is that even with PDUFA news, the stock could fall instead of rallying, possibly even below $6. I’m still trying to stay balanced, but that risk is definitely on my mind.

Obviously, we still have to get past the approval hurdle, but the worrywart in me is concerned that management won't get into TDAPA fast enough. This is from their 10-K filed at the end of March. Bold my emphasis, and my question is this: We have all been talking about application deadline for TDAPA is like the first few days of July. If they are successful and applying by that timeline we were thinking that OLC would be launched in Q3 2026 or is that deadline for a 2027 coverage? Because I have seen statements from UNCY that launch of OLC would be 3rd quarter this year and this 10-K seems to be referring to TDAPA in 2027? Not sure if I am confusing simple launch of the drug and the specific coverage timeframe for TDAPA.

Navigating the Bundled Medicare Reimbursement Environment
Over two thirds of our target patient population is covered by Medicare. Effective January 1, 2025, CMS transitioned oral-only phosphate binders into the
ESRD PPS bundled payment. To promote innovation within the bundle, CMS provides the Transitional Drug Add-on Payment Adjustment (TDAPA). If
OLC receives FDA approval, we intend to apply for TDAPA.
If granted, TDAPA would provide separate reimbursement for OLC at 100% of Average Sales Price (ASP), for a two-year period.
Following the initial 2-year TDAPA period, CMS has established a transitional risk-sharing adjustment under which dialysis organizations may receive
an additional payment equal to 65% of incremental costs above the bundled rate during a defined transition period of 3 years.
The TDAPA period applicable to certain existing phosphate binders is expected to conclude at the end of 2026, after which CMS is expected to
incorporate related expenditures into a rebased ESRD PPS bundled rate. If OLC receives approval and is granted TDAPA with an anticipated first-half
2027 launch, OLC may be the only phosphate binder eligible for separate reimbursement during its TDAPA period. In such a scenario, dialysis
organizations could receive both rebased bundle payments reflecting prior phosphate binder utilization and separate reimbursement for OLC during its
separate TDAPA period. We believe this dynamic may create a favorable economic framework for rapid evaluation and adoption of OLC.
Congressional legislation currently under consideration, the Kidney Care Access Protection Act (KCAPA), proposes potential enhancements to TDAPA
duration (from 2 to 3 years) and post-TDAPA payments (from 3 years to perpetuity) which may substantially expand the revenue potential for OLC. We
cannot predict whether such legislation will be enacted.
Competition
The market for hyperphosphatemia treatments is highly competitive and characterized by a well-established standard of care. Our potential competitors
include biopharmaceutical innovators and generic companies that market calcium-based binders, non-calcium-based binders, and novel phosphate
absorption inhibitors.
Current Landscape and Limitations of Standard of Care
Existing therapies are often limited by significant patient hurdles, primarily high pill burden and poor gastrointestinal (GI) tolerability. Standard-of-care
binders, such as sevelamer carbonate, often require patients to ingest up to 10–12 large tablets daily. This “pill fatigue” contributes to low adherence, with
studies suggesting a significant portion of dialysis patients fail to achieve target phosphorus levels.

My debate with Claude
Velphoro leaves 100% TDAPA reimbursement Dec 31st 2026 . OLC if approved starts 100% reimbursement ...so won't Fresenius want to switch patients to OLC especially if licensed by CSL Vifor9:44 PM

????Claude responded:
That changes the calculus meaningfully — good catch on the TDAPA timing.That changes the calculus meaningfully — good catch on the TDAPA timing.

The logic holds up:
TDAPA gives 100% separate Medicare reimbursement for new renal drugs for two years post-launch, on top of the ESRD bundled payment. If Velphoro's TDAPA window closes end of 2026, Fresenius absorbs its cost into the bundle — making Velphoro materially less attractive economically versus a binder still getting full separate reimbursement.

If OLC launches with a fresh TDAPA clock (likely 2026-2027 given typical approval timelines), there's a real financial incentive for Fresenius to shift volume toward whichever phosphate binder still carries that pass-through payment, regardless of which company licenses it.

This actually flips part of my prior reasoning:

The "cannibalization" concern for CSL Vifor becomes less of a deterrent and more of a necessity — if Velphoro is about to become a TDAPA-expired cost burden for Fresenius/VFMCRP anyway, CSL Vifor has a strong incentive to have a TDAPA-fresh binder ready to backfill that revenue, rather than watching patients shift to a competitor's TDAPA-eligible product (Auryxia, etc.) and lose the franchise entirely.

CSL Vifor licensing OLC could be viewed as a defensive/offensive portfolio refresh — replacing an aging, soon-to-be-bundled asset with a new TDAPA-eligible one in the same channel, using the same Fresenius sales relationships.

Fresenius itself has a direct economic interest in seeing some binder maintain TDAPA status in their clinics, so there's channel-level pull regardless of which company licenses OLC.

Revised view: I'd move this up from "low-to-moderate" toward "moderate," maybe 30-40% for CSL Vifor specifically — the TDAPA cliff genuinely strengthens the case versus a static view of the Velphoro/OLC competitive overlap. But this is still one plausible scenario among several:

Unicycive could partner with a different company (Akebia, a generics player, or a larger nephrology-focused pharma without the Velphoro conflict) that's hungry for TDAPA-driven dialysis revenue and has nothing to protect.

Unicycive could attempt to commercialize OLC itself in the US for the TDAPA window, since TDAPA economics can make even a small company's product attractive to clinics directly without needing a big partner's sales force — TDAPA is somewhat self-selling because it's a clinic profit center.
CSL Vifor could instead seek to extend Velphoro's life (reformulation, new indication) rather than licensing a competitor's molecule.

The TDAPA dynamic is a real and underappreciated catalyst for some deal happening in this space around the 2026 timeframe ( my emphasis ) — I just can't be confident it's specifically CSL Vifor versus another acquirer, without insider knowledge of ongoing BD conversations.
Worth checking Unicycive's most recent earnings call transcripts for any partnering commentary tied to the TDAPA timeline.
----------------------
Just need to get OLC approved first

Kiwi

Searched the webHere's the mechanism if OLC (Renazorb) gets FDA approval and TDAPA designation:...via Claude

Normal economics without TDAPA:
Phosphate binders fall inside Medicare's ESRD bundled payment (~$281.71/treatment). Any drug a clinic uses comes out of that fixed bundle, so a premium-priced branded binder like OLC would simply erode DaVita/Fresenius margins versus cheap generics (calcium acetate, sevelamer). Under that regime, the clinics have every incentive to avoid prescribing it.

With TDAPA: phosphate binders added to the ESRD PPS through CMS's Transitional Drug Add-On Payment Adjustment program get paid for separately, on top of the bundle, typically at or near acquisition cost (sometimes ASP+6%), for roughly two years. That flips the calculus — OLC becomes a pass-through reimbursement rather than a margin-eating cost, and can even contribute positive margin per prescription. Unicycive

That's why one investor framed it this way: how OLC will be treated in the dialysis bundle and TDAPA, and whether it's modified or extended, plus negotiations with Fresenius and DaVita is the second major value driver after FDA approval itself. InvestorsHub ( looks like its accessing a previous post I may have made on IHUB !! )

On top of the direct reimbursement incentive, there's a clinical/operational one:
Fresenius and DaVita would want to stock OLC because it dramatically reduces pill burden for hyperphosphatemia patients, and as the two dominant providers controlling roughly 80% of the U.S. dialysis market, both face pressure to improve outcomes, adherence, and clinic efficiency.

Better phosphorus control improves quality metrics tied to value-based care bonuses (e.g., CMS's ESRD Quality Incentive Program), giving a second revenue lever beyond TDAPA itself. InvestorsHub....( maybe your comment )
Caveats / friction points that the same investor thread raises:

Formulary gatekeeping:
large dialysis organizations' pharmacy software may require patients to "fail" on cheap generic calcium acetate and generic sevelamer before authorizing the premium TDAPA-bound OLC — a step-therapy hurdle that slows uptake even with TDAPA in place. InvestorsHub

Timing risk:
TDAPA for the dialysis sector's current drug additions is expected to wind down after 2026, so if OLC's TDAPA clock starts later, the favorable economics window for early adoption may be compressed, which is itself a reason for clinics to ramp quickly while the add-on payment lasts. Smartkarma

Approval timing itself is still pending — Unicycive resubmitted its NDA for OLC in December 2025 after its manufacturing vendor made progress toward regaining FDA compliance, so the TDAPA-driven incentive structure described above is contingent on that approval landing and CMS granting/extending the add-on payment for OLC specifically. Unicycive

In short:
TDAPA converts OLC from a margin drag to a margin-neutral-or-positive, pass-through-reimbursed product for DaVita and Fresenius, while quality-metric upside and the time-limited nature of the payment window both push toward faster adoption — tempered by step-therapy/formulary friction and the unresolved approval/TDAPA-designation timeline.. ( my emphasis )

Kiwi

Well in brief ...I went into this in more detail in earlier posts in the past week .
You need to understand how TDAPA currently works and why OLC will be the only pho binder in TDAPA in 2027 .
This changes everything .
Without TDAPA as currently structured ....the link you cite would be correct .

In brief TDAPA provides 100% reimbursement of new pho binders for 2 yrs for Medicare patients . Most dialysis patients are on Medicare
This means the large dialysis providers DaVita and Fresenius have their WAC completely covered although the patient may have a copay . Fresenius and DaVita have ways to minimize these co pay costs .

This 100% reimbursement ENDS Dec 31st 2026 for Velphoro ...the closest competitor to OLC and a major pho drug for the CSL Vifor / Fresenius clinics ...40 % of the US .

This 100% reimbursement STARTS for OLC Jan 1st 2027 ....giving CSL Vifor / Fresenius at least ...a major incentive to start switching at least their Velphoro patients to OLC ESPECIALLY as appears likely CSL Vifor licenses OLC .

Quick recap assuming OLC approval and filing for TDAPA on time
JMO
Kiwi

Thanks! Yes, would be nice to listen to Kiwi’s perspective!

I believe Kiwi will be best equipped to answer your question. The only thing I would mention is that I was under the impression that the "two large dialysis companies" would be incentivized if it improved outcomes, since I my understanding is that they are graded and reimbursed according to outcomes of their patients.

“You’ve been warned.

This approval might become a “sell the news” event. In any case, OLC will fail commercially (i.e. not achieve $1 billion in sales before patent expiration) because Unicycive isn’t operating in a fair marketplace. The marketplace for phosphate binders is basically controlled by two large dialysis companies thst are incentivized not to use OLC.”

Just found this from another forum discussing UNCY. Is this the real situation?

OK I bought some popcorn for the show tomorrow.

Is anyone buying SPCX with the 15 day hold restriction by brokers?

Hummmm so it is possible that we may see the same exact thing, a rare possibility but it is there non the less.

Wouldn't that be tragic if they snagged another CRL?

RMB & STU

Well, you know the saying: "don't count your chickens before they hatch."
So until we get this approved by the FDA hopefully by June 29, this is my answer & thinking.

Denis

Well we may be done or close to it re form 483's ...but ..although rare ...CRL's can be issued right up to the PDUFA date
Regeneron – Linvoseltamab (Multiple Myeloma)PDUFA Date: August 22, 2024CRL Date: August 22, 2024
Reason: Issued precisely on its action date.
The rejection was entirely due to unresolved findings from a pre-approval inspection at a third-party manufacturing facility.

Kiwi

IMO yes to 483 form period may be over