filing

adcom

Ardelyx Inc

approval

$ARDX what fucking morons are selling it’s approved there are some real dumb fucks involved in this stock good let them get the fuck out. Pussys

$ARDX if we have no approval  you know they are corrupt. .

$ARDX with a 98% chance of fda approval within a few weeks, what is this crap?

Denial of approval of such product  will need a strong justification or presence of significant risk (which is not applicable for Tenapanor as elaborated in the above detailed  
analysis).

but not expecting a ton of juice upon approval 🤞

$ARDX with all due respect, this price action today is embarrassing…nasdaq up 6% we can’t even break $1.30 embarrassing for real… I won’t even be surprised if we get approval next week and we stay stagnant for a bit.

The issue raised was probably one of the only negatives for approval:  The fact that we are using &#39;surrogate&#39; endpoints rather than the correlated clinical outcome.

Tena is already approved for IBS with a solid safety profile, and phosphorus management is a real issue in the CKD community with only binders being available.

insider

One red flag in this company, despite one director buying 1m worth recently, is the low insider ownership.

$ARDX less than one dollar soon insiders doing, given how corrupt the board and CEO are .

$ARDX company doesn’t say anything, insiders don’t buy, stock trades like total crap.

Kind of thing you expect to happen to a stock if the CEO is complicit in a INSIDER Trading SCHEME. .

patient

Those laxatives your taking are not working, you need the full Fleets treatment, a complete system flush.

I still remember listening to the meeting and getting mad at Alikhani, the so called patient&#39;s advocate.

The subsequent increase in intraluminal pressure leads to decreased intestinal blood flow, and in the case of our patient, intestinal ischemia.

They got something that improve the quality of life for dialysis patients and you guys called the trash company.

$ARDX&quot; I am a board-certified nephrologist for 30 years and was very disappointed to say the least by the denial of application of Tenapanor for hyperphosphatemia in patients with CKD.

However, the enrichment strategy did not appear to reliably identify patients who would have a larger treatment response to tenapanor.

As you think about your decision, I’d like to ask you to remember me and the other patients out there like me who are looking for solutions to help them.

Company sitting on the best fundamentals ever to date and we get treated to these stupid 1 liner worthless post.

However when patients get discharged compliance will still remain an issue because nurses and doctors aren’t there watching over them and making sure they take their meds.

trading

Obvious, as hell looking at tape today this trading was far from organic.

↳ Why are you paying to be in a Trading Room?

$ARDX 
With these absurd disconnected 80-100million-share volumes, trading price purely a construction of Dark pool, HFT, MM share-swapping, etc.

In the scientific community as well as in trading feeling get fucked.

reason

what a BS TREE SHAKE by MM&#39;s today was zero reason to let this drop like they did. .

I see no reason to hold or add at this point.

There would be no other reason for the timing.

$ARDX Ok, the only reason to deny our drug is negligible efficacy.

but that the FDA had denied access to for reasons no one understood.

Must be the reason this can’t get past 1.5

There is no reason for it to fall today like this!

He is one of the reasons that the SP stays down.

$ARDX I am thrilled that the chairwoman of our Adcom gave monotherapy a thumbs up.

So glad that I bought before ADCOM meeting.

$ARDX cytk failed Adcom yesterday, and went up! 😆

For the ADCOM had cast their votes, and they were overwhelmingly positive.

ADCom approval big + 
2. Insider spent 1M on buying shares at 1.75$ 
3.

$ARDX  We saw 1 leg, and nice consolidation today, post adcom.

With a positive adcom that occurred you are golden adding anything under $3.

All in all with the Adcom, insider buy and how Ibsrela is doing looking good here.

I am confident the AdCom will vote in favor of approval.

$ARDX Ready for a very nice ending to ADCOM meeting..

news

$ARDX Looking good, would be nice to finish the day in the 4&#39;s 
 
Still waiting on positive news from the company.

$ARDX very good fda news on this conference call

$ARDX just keeps doing things well, and good news should arrive soon!

If the trend of script numbers is anything to go by, guidance could be way better than Wall Street expects giving us a nice boost before FDA news.

$ARDX LOL, soon Xenopah News  😁 
Stay in, or buy

$ARDX good news coming man let’s goooooo

$AKBA within 3  to 4 weeks this stock could be over 2 heading to three like $ARDX .. gsk approval has helped.. fda news, ema opinion/ approval, partnership..

application

This is 100% normal and part of the growth of a strong company with excellent fundamentals and an FDA approval coming this year.

Better than money in the bank with soon resubmission and approval 2-6 months later!

And this is just a beginning, FDA approval will take it to the skies.

Pretty Bullish ER going to give us an update on FDA when and etc. .

$ARDX This company is sitting on a mountain of great fundamentals.. 40++ medical patents ,,, 40+ more in application status 1 drug approved IBSRELA 1 drug almost aproved XPHOZAH a kidney drug that could pull an annual billion dollar + revenue.

bull

🎉

Have a great evening bulls and longs. 🍻🍻🍻

Hold strong bulls we’re not going anywhere 😤

$ARDX I’ll see you bulls in the 3.90s today 😤

$ARDX wow and just like that there’s no more bulls 🤣🤣🤣

A close above 4 will be huge for the bulls

Cheers and see you all tomorrow bulls and longs. 🍻

$ARDX  Looks like a bull flag on the daily morning here.

$ARDX $APRN $BLBX Have a great night, Bulls and Bull-ettes! !

Advanced Micro Devices Inc.

Red and green horizontal lines that have not been crossed since being created are untested.

Red and green lines that have not been crossed since being created are untested.

Red and green lines that have not been touched since being created are untested technical support/resistance.

Red and green lines that have not been touched after being created are untested.

$AMD too bad its best of my list on a red day..

$NVDA $AMD $QQQ NVDA earnings weren’t great, lot of red flags

If your red or blue it’s just a big mess.

signal

BUT, there is a possibility of free fall in the signal, which is why I mention it.

$AMD Hearing lots of “Uhmm” or “Uhhh…”

Worrying signals

$AMD GOD DAMN JUST GOT BACK FROM BACKCOUNTRYING CAMPING NO SIGNAL AND I GE HIT WIH THIS HOLY FUCK

They just wiped all the long signals off the board.

but they are very difficult to make use of because they are intraday real time signals.

hold

Very frustrating to hold this stock when you know what you own.

Daily options hold no redeeming value in this decision.

Nazi Joe Biden is the most incompetent person to ever hold any position of authority in the history of this country.

$AMD how did this hold up with that SPY dump holy shit lmao

Go shoot yr car file Insurance Claim dumbass.

He fell asleep at the wheel and the car is still swerving for the guardrails!

Somebody should firebomb their office and key their cars.

$AMD $FREY $PLUG This has been a dismal day here on the semiconductor and ev fronts,

$AMD $CRM $MSOS $NEON $TSLA 
Scammers 👇 
Dumbest room on the discords - I’ve lost my house, my hoes, and my car by losing over 175k + with their shitty alerts live-trading-profit-stock.1Bullshit.com

Join today and start losing immediately

Wallstreet will take ur car 3 times in one day.

Molotov Cocktail their Homes, baseball bat to their cars, could provide much needed comfort to the suffering they causeed.

Molotov Cocktail to Woke Cuckoos Homes and a Baseball Bat to their Cars could be provide comfort and solace for what the Cuckoo Trash did.

Taking a baseball bat to their cars is ok, and will make you feel better.

Out of nowhere, a woman got into my car, I was like, wtf.

$AMD breaking working Americans hope for retirement and sacrificing Ukraine civilians to  enrich a comedian and cronies is not what
Elected Joe for.

On the 1st day the MORON declares war on OUR Fossil Fuel industry, BUT WITHOUT Infrastructures in place FIRST for green energy?

Please China do not Invade Taiwan and take our ORDERED chips from Taiwan Semiconductor for yourself.

: 
The Manchurian Candidate!😧 
 
Yes, everything oBiden&#39;s Admin has touched has turned to s***!😖; But nobody can be this INEPT, (as gas was up over 50% before Putin invaded Ukraine!).

$AMD This stock has become uninvestable now that there is a chip war between the US and China

$AMD During the press conference, Putin was asked if he had any regrets, and replied in the negative: &quot;I want to be clear - what is happening today is unpleasant, to say the least,

but too much geopolitical risk, specifically with USA restrictions &amp; sanctions risk

$INTC $NVDA $AMD $SPY

$AMD This happens when you support a horrible country like Ukraine!

I have one italian future structured contract product on AMD shares for Long/Short in view, need to see AMD filings this weekend if is my best investment choice to take in action. Love AMD my best investment return of all time ))

but nice run on earnings from AMD 
 
  
SRPT will have a FDA BLA Acceptance filing any day now expect 112 then gap up to 140-150 on news with no adcom and FAST TRACK by FDA!

chip

$AMD my gawd that eod was glorious 🤑💸💰 .. more to come.. for the bears 🤣🫶

$AMD $NVDA what  a  beast  -  chip  companies  are  the  next  trillion  dollar  market  cap  companies  im  next  5-10  years  -  bears  are  done

$AMD was the market&#39;s top quarterly gainer, rising +41.74%.

$AMD chart is pretty strong and look good.

$MSFT $AMD $NVDA $AAPL still out -performers!

$SPY bimbo bulls absolutely rugged and trapped. BEAUTIFUL!!

$SPY love that big inverse h&amp;s
Eventually its gonna take us to 450
🤝👊🏻😮‍💨 btfd and go on vacation 
$AMD $AAPL $MSFT $AMZN

$NVDA $AMD $TSLA $QQQ BIG BULL DAY TODAY!!!! !

$MSFT $AMD $SPY  APT / USDT - APT bullish or berish 
 
📈FREE trade-of-week via(Go to) ⟶  𝐟𝐫𝐞𝐞𝐚𝐥𝐞𝐫𝐭.𝐩𝐰

$TSLA always keep this one $NVDA $AMD $DIA $NDX ✅✅✅✅✅✅

$AMD $NVDA $FRC $TQQQ  
Going to be a Great Day.

$FRC let’s go $SPX $TSLA $AMD 😁 $BAC 🟢🚀🔥🚀🟢💰

The Bulls are bullheaded and will spear this bad boy to 110 by next week.

Intercept Pharmaceuticals Inc

Every positive news is shorted to oblivion.

Getting the feeling they will have bad news soon.

No possible good news can come out in months and months

management

Definitely bad management, and a product that almost no one seem to believe in anymore.

Management just needs to get their asses in gear and get the sNDA refiled ASAP.

$ICPT insanity how much incompetence this management has!!!!

Now management’s sluggish pace ensures the downward spiral will continue,

$ICPT unbelievable how much time and money this management has WASTED

And this is a highly risky stock because mgt is not strong and does not communicate.

drug

RETA just did as there wasn&#39;t any treatment for their indication.

I don’t buy that because this was a Trial Drug !!

It’s a shame that no currently approved medications exist for the treatment of NASH

business-result

but it looks like too risky with mixed trials results.

Huge disappointment after nearly a year delay to get bad results. Sigh

but then again they have emphasized they dont need Reverse to submit Regenerate results and no additional safety is what they observed.

company

$ICPT We’re trading like a standalone PBC company, which is ridiculous.

$ICPT Well, looks like this company cannot do good for WS, we are again price as if all failed two month before AdCom.

No one has any confidence in this company, or this is pure manipulation by some greedy parties.

$ICPT this is dumb, the company mentioned many times there will be an adcom

So tired of this company and the way it acts.

I am at a loss, this is surely manipulation, someone wants this company to fail.

$ICPT Clearly the market has no faith in this company.

Let me close by saying incompetence of the company was by a few not a whole

These idiots will announce a delay in resubmitting on the last business day of the year just to guarantee they destroy this company.

$ICPT BLA filing in nash within 45 days with great data.

I predict the Adcom Board will give OCA thumbs up and then a swift approval thereafter.

We are unanimously gonna get the thumbsup at Adcom in light of extensive efficacy and safety data and OCA is gonna be approved before the set Pdufa date unexpectedly.

Adcom is only a positive thing what the company wanted and they have emphasized that numerous times.

So much potential upside if/when approved for NASH.

$ICPT getting an Adcomm; this is positive, there is no doubt in my mind, that Adcomm panel will understand Risk/Benefit warrants approval.

What approval will do is finally give patients some hope and will put ICPT on the path to long term profitability.

Any weakness today will be recovered quickly by close , their safety profile for OCA is good and should go a long way helping with approval for NASH , my take . GLTA

This will rise and once approved, we&#39;ll get our BO is my guess.

MDGL once it is approved will dominate this market

quot

,&quot; We are really excited about the fixes combination of OCA plus bezafibrate.

So we feel comfortable that the work we&#39;re -- the ground work that we led with PBC will translate very efficiently into a NASH, potential NASH launch.&quot; Linda Richardson

$ICPT &quot;NDA is supported by robust NASH clinical development program, including two positive interim analyses from the Phase 3 REGENERATE study demonstrating OCA&#39;s improvement in liver fibrosis without worsening of NASH&quot;

This efficacy, together with extended exposure in the largest safety database in NASH, supports a positive benefit:risk for OCA in patients with fibrosis due to NASH,&quot;

This is a 16.43 percent increase over sales of $66.64 million the same period last year.&quot;

Importantly, given the recent strategic transactions that have strengthened our capital structure, we are well-positioned financially to manage this critical time while building for the future.&quot;

&quot;This quarter&#39;s performance reinforces the underlying strength and value of our PBC business, and there is significant opportunity to grow this franchise given the number of patients who remain eligible for second-line therapy.

This should start the ascent soon in anticipation of FDA outcome which is leaning positive to me , just my take GLTA

$ICPT I am glad the application was accepted, otherwise we would have been at $5, if that

It is obvious that ICPT took care of the issues of concerns from the first application.

In these analyses, OCA 25 mg consistently demonstrated double the response rate of placebo in reduction in liver fibrosis stage without worsening of any of the three histologic components of NASH, an endpoint consistent with FDA&#39;s draft guidance.

“We believe OCA has the potential to become an important therapy given its strong and direct antifibrotic effect, and we look forward to continuing our work with FDA over the coming months as they review our NDA.” $ICPT

Top Stocks matching your search for "filing adcom"

Click Learn More to know about Stock Advisor's top picks. We've 3x'd the S&P 500 over the last 20 years.

ARDX

Ardelyx Inc

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ICPT

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ARDX

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23.58%

$3.35 - $4.14

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AMD

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15.22%

$84.69 - $97.58

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ICPT

Intercept Pharmaceuticals Inc

-34.51%

$20.75 - $13.59

Nov, 21, 2022