filing

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.

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

$ARDX very good fda news on this conference call

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. .

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.

$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..

$ARDX when we get fda approval will be shining

This should be seen as a REALLY good thing - because they will need cashflow soon - one would expect - assumption being FDA response is close and production and marketing is about to get kicked up a notch. .

Things to look forward to..  NDA refile announcement, Q4 results, weekly IBSRELA sales increasing now that we are through the holidays, FDA approval, Japan approval, launch of Xphozah.

They just got approval for 1 drug from FDA and things are bot going well there..

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

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

$ARDX good news coming man let’s goooooo

application

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

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

So glad that I bought before ADCOM meeting.

$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! !

Edesa Biotech Inc

A company to lose close to 25% in 3 days on no news shows Gary is absolutely USELESS.

$EDSA Whatever the news is (that somehow got leaked and is responsible for this going up more than 100% in a week) once it is properly announced I will GTFO and never come back to this Indian scammer Pars POS stock.

but watching APVO today is not very comforting for when we release news.

$EDSA These shitheads aren’t sharing the good news.

I simply want to see Edesa Biotech management try to put out any positive news release during this year and then realize that their news release once again had the opposite effect in moving the share price down another 41%+ during that day.

40-50% crushed on good news and then no rallies at all.

rate

Patients with rapidly improving ARDS still had a 55% mortality rate, much higher than earlier reported.

but embarrassingly, the FDA isn&#39;t impressed with an 84% death reduction rate? WTF?

3) QUESTIONABLE TRIAL GROUP - High placebo mortality rate and wide variance of dosed patients (L4 - L6) make it impossible to know what patient exactly should receive the  drug in Emergency Use, hence why they would like to see another trial.

Lowers the body temperature almost immediately, almost at an disturbing rate.

Short Borrow Fee rate has increased from approx 6% to 8% !!!!

Still don’t think it deserved an 8k when we can’t even get main asset trial approval prs for years.

but it scares the shite out of me that the FDA has not approved our trial in over a year.

but starting phase 3 sometime this year, eb05 in trials and asking for fda phase 3 approval in numerous USA sites, just announced a EB06 trial starting in Canada and eb07 coming soon this would have to be the most idiotic bio company in Canadian history.

$EDSA they have 2 products, both of which are not FDA approved.

It seems a wee bit like some kind of half broken pump which had been purchased from a  bargain basement or fire sale clearance kind of vendor or a PUMP which would be purchased from some gold caps toothed Tamil Sri Lankan, lol.

1) Phase 3 FDA approval is imminent as it makes no sense for them to acknowledge the need for this drug and not be more flexible with the trial protocol.

The only reason VERU did not get EUA approval was due to a weak safety profile.

And the pipeline chart on website is so misleading cuz our P3 protocol is even not yet approved by FDA

business-result

$EDSA 

EBO1 Stat Sig results

Reached Primary Endpoint 

Dropped 44%? WTF?

$EDSA disappointing management hasn’t come out defending the EB01 results.

$EDSA long time bulls like Mr. Bitcoins are leaving forever after these terrible EB01 allergic contact dermatitis results … it’s over sad to say … at least the company tried their best,

But, let me tell you why the Bulls have disappointed me - nobody seemed able to defend these top line results and the Bears for being stupid lucky.

$EDSA Results were not good and even more concerning was that the higher regarded 2% dose showed nothing.

There may be potential to improve the results further.

but they can pass on their illness to others and, as a result, you need to protect yourself from them.

The delay is merely serving long ago determined intents on the part of this fack named Par and his fellow Edesa Biotech accomplices; and we may be losing just shy of every single penny we place here with Edesa Biotech Inc as a result.

executive

Edessa is dead and her CEO is a swindler.

Wouldn’t it be great if the CEO could even spare 1 hour every quarter to write a shareholder letter…

The CEO adding provides me no solace anymore.

Small buys by the President and CFO, and yet the share price just keeps collapsing.

What I love about this stock is the probability of EUA Filing and the fact WE DON&#39;T HAVE TO WAIT FOR FDA APPOVAL IF EU, THE STOCK WILL EXPLODE ON THE FILING ALONE!

But what makes it amazing is the investor deck and website will still say  “in talks with fda on phase 3 approval”.

$EDSA Ruxolitinib (Opzelura) approved by FDA last year seems like a very solid drug for curing vitiligo and is generating tremendous revenue to Incyte.

FDA was pleased with their results and understands HC is moving forward.

* granted FDA fast track status late Dec 2022
* 75% of drugs given Fast Track get approved
* ARDS current has limited treatment options, could make a big impact 
* CEO has sold two previous biotech companies to bigger players 

Let’s get it 😍🎊💥🆙✅

Fast Tracked FDA status on a drug with no competition.

It looks like EB05 is gonna be that home run, with FDA ‘Fast Track’ designation at the end of Dec 2022, we’re almost at the finish line.

FDA mulling over Emergency use right now I bet 

Holding strong. .

but to PR the positive review and approval

They did exactly that with Fast Track, and also Compassionate Use

BOTH APPROVED BY FDA!

but my god everything has aligned for some very very very good news

$EDSA Not a single negative news about this stock and yet the price is falling .

$EDSA friends 
 
Great news 
 
In 2027 we might reach a profit 
 
Hahahahahahahahahaha

company

but I like what the company is trying to do/develop and the good it would do if successful.

$EDSA multiple billion dollar company. 🤦‍♀️

but this company never ceases to disappoint.

$EDSA Pretty pretty pretty neat  that myself and 3 other retail I know own around 5% of this company.

But, I do think good things are coming the way of this company before June.

$EDSA I’m literally so feed up with this company and stock.

One thing you have to give props to this company is their management of cash.

volume

$EDSA -9% on 50k volume is an astonishing accomplishment.

Short volume Ratio for last EIGHT straight trading days is averaging about 60%+

🧐

$EDSA last night&#39;s close was a very good close with very good share volume

however what we can see, apart from all our assumptions about it, right or wrong, the volumes are high compared to the previous months, which means a lot of interest in the title

$EDSA Reasonable volume everyday since 12/20.

$EDSA good volume today 1.5 of average 
We are on the right path

then news..then some real volume..up up and away

$EDSA the fact that this rise has been steady and medium volume is a good thing.

American Virtual Cloud Technologies Inc

account

$AVCT prez got his booster shot in his booster seat with ice cream after, forgot to hide the suitcase of Phizer cash under the chair that punter forgot to put in their joint account, sorry just bored?

$AVCT Dark Pool accounts for 77% of the total so far today as they manipulate the price 🖕🏽🤡

$AVCT the only thing that upset me this afternoon is i had to pull $500 out of my bank account to average down.

This company&#39;s management has destroyed my mental health and my trading account.

.I tried to send money to my TD account and nothing.

Then when I looked into my account I got this wtf.

$AVCT is the HUGE loss in my etrade account just due to ABCT not being listed so it looks like I lost everything in it?

I don&#39;t like my account showing $464 when it should be closer to 7k on a ticker symbol that doesn&#39;t exist!

$AVCT 
I just checked my RH account and strangely it says +330.00 for an unknown reason.

fear

Novice investors beware of these kind of people.. they spread fear with out knowing how to invest. .

Soft peddling fear, uncertainty and doubt.

Stop losses were Tripped , fear took over.

$AVCT this has 
nit changed all day so you know it’s just adding fear

$AVCT Blocked 🚫 almost 7 bears 🐻 who were spreading fear and trying to destroy our beautiful dreams.

He just writes random stuff in bold red to spread fear

holder

$AVCT I truly feel bad for you holders listening to bagholders from a “space call”ask them to post their position..I bet you they won’t

$AVCT wow officially a bag holder with this shit

Here is mine..proud bag holder, now what bitch!?! ?

Something better be in the works, or literally almost every holder will be a bag holder here for a loooong time.

They seem overly concerned with what us share holders are doing , as if it was their money we are investing .

$AVCT the management played a significant rule in destroying share holder&#39;s value and I have no reasons to think that this happened with good intention.

$AVCT no announcement of offering closed, no announcement of regaining compliance 

So we, retail holders get shit on. Nice

So far all news we had were bad, for stock holders.

LIES BY PUMPERS AND DELUSIONAL COWISH BAG HOLDERS.

$AVCT average price of holder is $3.8 🤦‍♂️ 😂 down over 100k on this shit why sell now

demoncrats

$AVCT some democrat reported me for saying fuck Brandon I guess I hurt their feelings maybe they should spend more time trying to figure out how to kill more unborn babies and leave st alone

Welcome to corrupt democrats America with Citizens are nothing

$AVCT 

Right now you’re witnessing and a victim of crime and white collar robbery 

It’s equal to you getting robbed by the guy in the alley and stealing your money 

Fuck joe Biden and his elect Gary gensler

$AVCT why is everyone acting like it’s just going down cause they suck lol if anyone watches the actualllllllll fucking market that we buy stocks on it’s the most corrupt shit since Biden was elected ………disgusting rat fucks

pressure

Plus have illegal naked shorted,  manipulation..no buy pressure.

1.4M Nano-float with huge  insider filings out yesterday..  
  
Top candidate for continuation!

.Institutional ownership keeps going ⬆️ since 8k filing in sept.

$AVCT Filing has me thinking  we could be headed ⬆️ im excited only positive vibe here :-)

$AVCT If anything, the filing is bullish to $1.79 up to and on Dec 05.

$AVCT Bulls will be happy with this price action when everything plays out, no excuses for not averaging down or building a better position,  If you read the filings you know what&#39;s coming

$AVCT love how a SEC filing wakes up the bears. 🤣

This is an insanely positive 8-k filing, and with Microsoft releasing they need better cloud systems this actually should be at the moon.

Reading through the filing 

- first 5 million sold out of existing shares = no dilution.

The company is more stronger, financially today after this filing than yesterday.

The filing today was bullish with direct institutional investor, as mentioned.

This formula has already proved to be effective, and if FDA approved can potentially be sold for billions.

Just buy and hold if you have conviction in your DD

..but now everyone just focus on Buy out, this is triple win win game ending  the KO to all bears😎

$AVCT Let me guess… the buy out🖕🖕

$AVCTW $AVCT volume and price, this thing goes up 2c with like 10k buy! amazing!!!

$AVCT Buy before it Breaks out Run incoming Dec5th👨‍💻☁️🤝😎💵📊🚀

$AVCT Good morning Bulls. ✌️
#patience

I’ll be back in a week see my bulls soon i wish you the best!

$AVCT morning bulls, looks like it’s moving in the right direction.

!’

 $RVPH always a bull 

 $AVCT looking nice here

$AVCT let’s go Bulls We’re $AVCT warriors 

We’ve waited 

#notselling until Buyout

$AVCT this is another great call by @Deepbluewhale just as there’s paid bears there’s also paid bulls don’t get it twisted

hold

$AVCT 
I bought the dip and I will buy the next one too Hold for the GOLD

$COSM always fun $POL another Dec to remember stock to hold for news

(6 months later after no buyout)

&quot;This was always a long-term hold! &quot;
🤣😂😅😄🤡

as long as 1$ holds from here looking bullish for a push to 1.46 soon

Top Stocks matching your search for "filing fda"

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