Unicycive Therapeutics Inc (UNCY)

Hi Ernie I dont think trend analysis applies here due to the binary event nature of the catalysts immediately in front of us .

We are awaiting the inspection of the subcontractor facility .

If we get a form form 483 ...stock will immediately drop .
If we dont get a form 483 but the inspection is delayed until August ...we miss the October 1st TDAPA cut off even if we get a Class 1 resubmission.

So the range of outcomes goes from

Best case scenario....Pass inspection and Class 1 re submission awarded and filed by by end of July ..IF that happens stock will be a lot higher .
Followed by the Class 1 review ending late Sept and OLC approved ....and Co immediately filing for TDAPA before the Oct 1st TDAPA cutoff ...stock will be a lot higher again .

Worst case scenario ..... Obviously a form 483 this month which means Co would have to respond to that by mid August and then if we get a Class 2 re submission we are 6 mths before the FDA decides wether or not to approve . In that case stock will be a lot lower .

In between case ....FDA does not inspect facility until August . If we pass inspection and get a Class 1 re submission we miss the Oct TDAPA cut off even if approved . Stock will still be up but Co will probably raise $ thus capping PPS increase .

JMO
Kiwi

Agree ...Just spent some more time looking at the time line and I''l detail in response to Ernies post

Kiwi

With FDA, July 20 probably low chance

Yep, always has been a revolving door between BP and the FDA 

From Dew’s board:
“ FDA suspends public disclosure of CRLs while studying how to do it without revealing confidential info: 
https://www.fiercebiotech.com/biotech/fda-halts-release-new-drug-rejection-letters-while-working-formalize-policy

Sure . The timing of this inspection is almost becoming a binary event . IF they get that done and pass it by July 20th ...followed by a Class 1 resubmission, the a TDAPA ap by the Oct cutoff is doable .
If they dont get it done and passed by July 30th ...then we probably miss the Oct TDAPA cut off even if we get a Class 1 resubmission .

Doing some work outside so may take awhile to reply to any email

Kiwi

Trend Analysis
UNCY appears to be in a bearish medium term trend within a longer-term uptrend. Although the 200-day moving average is rising, the MACD is bearish. Comparative Relative Strength analysis shows that this issue is lagging the S&P 500.
As of 1:15 PM ET Thursday, 07/09/2026

I got my orders placed, the 1st is possible from my interpretation of the chart the 2nd one will create a whole lotta ledge jumpers(hopefully from ground floor windows) I'd hate to lose any of you UNCYers

Thanks RMB and Kiwi

Thanks Kiwi, as I figured you would have the correct info for us invested in UNCY.  I am going to impose on your knowledge on something related to construction in an email later today, if possible. 

Hi RMB. The TDAPA applications are quarterly .
So next one will be October 1st ....or week of starting October 1st
So the question is ...Can we get an inspection done , facility approved and a Class 1 re submittal with a PDUFA date .... say Sept 29th .
If so we are will be a lot higher .
If not we may revisit Ernies " Hard hat" low .
JMO
Kiwi

I think it is a given now that we have lost the window we were shooting for. What I don’t know is whether the windows are quarterly, yearly, or semi-annually.  Kiwi (aka EF) I am sure will opine.  

I kinda lost the thread on the TDAPA situation as it relates to the delay. Are we into the next window on that. Thanks much

Per Kevin from IR….FYI…..fda inspection has been assigned and should happen “near term”

It’s a Schedule 13G/A, meaning an institutional holder amended its beneficial ownership disclosure. This one is from Millennium / Integrated Core Strategies / Israel Englander, and the filing shows they are now at 5% or less ownership. The event date is 06/30/2026, which lines up with the CRL selloff date.....so meh. Nothing really to see here. Less than 1 percent of shares.

https://d1io3yog0oux5.cloudfront.net/unicycive/sec/0001104659-26-081878/0001104659-26-081878.pdf

Here is the answer from AI: If the price was $5.80 at the strat of the down side,
Mathematically, a stock price dropping by 10% daily will never reach absolute zero because it decays exponentially, but practically, it will round down to $0.00 in 67 days (or drop below 1 cent in 61 days). If the 10% drop refers to a fixed amount based on today's initial price ($0.58 per day), it will take exactly 10 days.

“ FDA may not even show up for a facility inspection pre June 29th”
Kind of egregious behaviour.  I guess there are no rules that we can rely on the FDA to follow. 

Re My WAG is the company sells in the AM and stops once it drops near 10% - it's what they call a pattern
Well if that pattern repeats itself day after day ...drops 10% then stops ...each day ...how many days before we hit $0 ?? .

Just messing with U .
I never considered the FDA may not even show up for a facility inspection pre June 29th ...so what do I know
Good luck
Lets see how long Ernies " hard hat " bottom lasts for

Kiwi

Wow we got another EF on the board

I pointed out the negative so I thought I'd post what I consider a positive as the day progressed.

Equal time but yeah I'm more washy then wishy. My WAG is the company sells in the AM and stops once it drops near 10% - it's what they call a pattern

Oh don't be getting all wishy washy positive on me now .....:---)
I prefer the stock when most hate it .
Off course I will be totally wrong if this drags on for 6 mths -1 yr , with a Class 2 re submission

Kiwi

Nice to see it recover some lost ground from this morning.

Warning - Everyone should wear fall protection today as it is crumbling again.

Hard hats are highly recommended


Congrats ...you nailed the bottom ( today ) with this post

Kiwi

If so I’ll double my position again ….buy low sell high 👍

My read of the chart indicates it's going to drift lower but remember I have chart reading dyslexia

I see $1.32ish as my next buy

I nibble I don't have a whale's appetite - buying some others I find "interesting"

Hope you’re buying or adding Ostx….I’ve almost double my position in the last two days

Since it's a red day I added some AEMD for shites and gigglies - From my guppyish understanding it is another ICU type filtering system but not for AKD

https://pmc.ncbi.nlm.nih.gov/articles/PMC8531584/

Well IREN is hurt by the META news . META may be selling its own compute power ...so less demand for IREN's
Fewer Iranian drone attacks in the Persian Gulf ...so less need for AMPX's batteries in surveillance drones ....where they were mainly used over there.
Micron ...the whole memory chip trade was going crazy in Korea ...a correction was inevitable .
Sold all 3 some time ago
UNCY is enough of a roller coaster for this timid soul

Kiwi

Re your comment I'LL KNOW IT WHEN I SEE IT ...oh stop being so modest ( and in all caps to ) .
So far your " hard hats " comment has marked today's bottom ...so you're on a " contrarian " roll ....:---)

Kiwi

So I think it has already been underway.  Some high flyers are down 30-40% from the highs. IREN, AMPX, etc.  There is a rotation away from some high flyers into oversold beaten up stocks.  Micron down from 1200 to 900. 

To be fair I see lots of red today - I'm trying to figure out when the "correction" is gonna hit

IT IS COMING BUT WHEN ? I'LL KNOW IT WHEN I SEE IT NOT A SECOND SOONER

Well your hard hat call was around 10am ET ...so near the low of $5 .01 today ...Lets see of that holds
Kiwi

In 2009 I was just starting to tinker with 000 pinks to begin my obsession with stocks.

Do U or anyone else here remember this ...Mark Haines wearing a hard hat on the floor of the exchange

The late CNBC anchor Mark Haines famously called the exact bottom of the Great Recession stock market crash on March 10, 2009.
This iconic moment became widely known on Wall Street as the "Haines Bottom".
The Legendary Call
The Timing: At 9:47 AM ET on March 10, 2009, during CNBC’s Squawk on the Street, Haines looked at the cameras and stated, "I think we're at a bottom. I really do."
Market Context:
The S&P 500 had closed the prior day (March 9) at its absolute lowest closing point of 676.53 (with an intraday low of 666).
The Rarity:
Haines was known for rarely making explicit market predictions. His gut-driven, contrarian call occurred during a period of peak global financial panic.

The Legacy: The market never closed lower than its March 9 level, kicking off a historic bull market. In 2021, CNBC even auctioned a non-fungible token (NFT) of the historic footage for charity.
--------------
I think his call was while sitting at the desk , but he had been admonished by CNBC mgt earlier for wearing a hard hat while walking around the floor
The Hard Hat contrarian indicator
Kiwi

Warning - Everyone should wear fall protection today as it is crumbling again.

Hard hats are highly recommended

Well wouldn’t you know it.  On the day that I write a post bashing lawyers and class action lawsuits, I open my mail and see a cheque from the Axsome Litigation whatever for hundreds of dollars.  Egg meet my face. 

Yes, it’s true, the FDA has a permanent field office in New Delhi. It’s been there almost two decades. FDA agents normally perform over 200 inspections in India annually. One almost every damn weekday of the year. So, if they’ve fallen this far behind, they’re more shorthanded than I surmised. Maybe a little less chicken tikka masala and more laboring? I wonder if they’d put Merck or Pfizer though this agony? I doubt it. It’s great to hear it’s been assigned and that there’s a sense of accountability to get this done. There should be we paid $4.68 million to refile our submission.

When you say “India based”, do you mean they are stationed or domiciled there?

Tutes were buying Ernie . Gupta doesn't control the India based FDA inspectors .
Only thing he can do is raise some cash thru the ATM before June 29th , in case you know what hits the fan ...which he did .
JMO
Kiwi

Good buying op. Story remains the same . OLC will likely be the best in class pho lowering med for dialysis patients .
Its just a question of timing .
Do the India based FDA inspectors get the inspection done in the next week or two and then the FDA issues a Class 1 resubmission ...or do they F around and we end up with a Class 2 re submission

Fantastic soccer games yesterday ..for this watching

Kiwi

Where where I ain't hear no sirens?

Nobody did anything to them - it was bad management that has caused every single problem they currently face. If I was a tute I would be all up in Gupta sht for his failures

That’s not to say that I would give glowing testimonials about management. 

I once had pests in the woodwork of the old home I grew up in. Used Lindane to eradicate them. Not sure if that substance is legal anymore.  You know what you call it when you have 10,000 dead lawyers at the bottom of the sea? — A damned good start. 

Ambulance chasers coming out of the woodwork again 😮

What a game.  I actually think I was experiencing angina just laying on the couch watching during those last 20 min.  I didn’t think 11 min extra time was correct but i guess that is home field advantage.  England had to overcome a lot of obstacles tonight.  And the red card foul that forced them down a man was not as bad as Balogun’s, in my opinion.  

ok They may not go all the way, but as of now, they are still in. Big win vs Mexico, especially when having to play 10 against 11 players.😅