Positive thoughts attract positive vibes
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Yup. Accumulation by retail and institution. The price only pushes higher as the weaker hands fold.
huge green bar on the chart.
https://fintel.io/so/us/ardx
Looks like you were wrong. In a new trading zone, basically consolidating again after that leg up. More catalyst to come. $6 - $9+ coming by years end.
Its all up to the FDA. The FDA knows it works; when they rejected it the first time "for clinical meaningfulness". Basically saying it does what it is supposed to do, but what benefit does it have for the patient. Hopefully the testimony and positive votes in favor during adcom will persuade them to approval. We will find out before years end...
New Standard of Care potential.
In the OPTIMIZE phase 4 trial, Xphoza as monotherapy helped 63% of patients with uncontrolled hyperphosphatemia who were naïve to phosphate binder therapy to achieve target serum phosphate levels. For those with uncontrolled hyperphosphatemia despite being on treatment with phosphate binders, switching to Xphozah or adding Xphozah to a reduced binder dose enabled 34% to 38% of these patients to achieve target levels.
In the NORMALIZE phase 4 trial, up to 49.4% of patients treated with Xphozah monotherapy or in combination with sevelamer achieved a serum phosphate level within the normal range during the 18-month treatment period, which is 66.3% better than standard of care.
Source
https://www.formularywatch.com/view/fda-approves-novel-nasal-spray-for-migraine
Let them drop the price, opportunity for others to get in for the eventual climb. I think at theses prices we could see another +100%
Ouch! Sorry to anyone that had a position here.
I'm curious to see if that 2000 option purchase on 1/20/23 for April $12 strike is going to print. It was near $1 each and last week it went down to $0.35 now its almost back up there.
I haven't bought shares since $4 bucks, just enjoying this ride with the rest of you longs. Appreciate all the wisdom, research, and encouragement that you guys provided throughout our journey! AUPH! LFG!
Next catalyst: The company currently intends to submit the NDA early in the second quarter of 2023. Early meaning April or beginning of May?.. from there its a waiting game.
Holding since 2021, crawling out of the dumpster
They got their options. Oh edit... New employees
https://ir.auriniapharma.com/press-releases/detail/282
Right! nearly 50 million volume and only goes up less than a buck...
So quiet here on such a great day!
Indeed a long way! The mentality of new investors is if you don't make money in a day, week, or month you're a bag holder. They cannot grasp the concept of an evolving technology that is growing faster than the internet. They use the internet yet cannot connect the dots of what got it there. And here we have BTC which is completely decentralized, no ceo, no advertisements, and growing faster than the internet itself. The infrastructure (internet) for this technology is already in place. The growth will explode and by the time those new investors realize it, they will buying their Sats for $400k and selling for $405k saying I told you its going down to $390k lol. All that while we are sitting on our full coins.
About 46 million Americans (roughly 22% of the adult population) own a share of Bitcoin. Source https://explodingtopics.com/blog/blockchain-stats
IMO probably 40 million of them don't really care what the price is, what any chart says, they just slowly buy. And then you factor in the fact that this is borderless and many other people are accumulating around the world. They ain't looking at no chart and they can careless what Americans are doing.
Anyone with a smart phone is capable of owning bitcoin. In 2023, the number of smartphone users in the world today is 6.92 Billion, which translates to 86.29% of the world’s population owning a smartphone. Source: https://www.bankmycell.com/blog/how-many-phones-are-in-the-world BTC has the largest network of people and its growing. In 10 - 20 years it won't matter if you bought at $60k, $20k, or $10k because whatever you bought it at it will be significantly more.
Then you look at Central Banking System. Not going to even get into that....
DCA! bullish long!
We should be hitting new 52 week high tomorrow. They absolutely smashed expected revenue and EPS.
CEO Mike Raab:
In addition, last quarter, we experienced an overwhelmingly positive Cardiorenal Advisory Committee vote supporting the benefit of XPHOZAH, which was then followed by the Office of New Drugs, granting our appeal and instructing the Cardiorenal division to work with us on an appropriate label for XPHOZAH.
We are moving quickly towards our NDA resubmission, and in mid-February, we held a Type A meeting with the Cardiorenal division. It was a very positive discussion and we are really appreciative of the time and responsiveness of the FDA. We are now completing our work on the NDA for XPHOZAH and are on track for resubmission early in the second quarter.
As we have said before, our base case expectations or that this will be a six month Class II review. We of course are hopeful that it could be shorter. Regardless, we are well-positioned and will be ready to launch in the second half of this year if approved.
Crushed it! It's pretty impressive what their little sales team has accomplished. When Xphozah comes to fruition. This is going to go ballistic!
I can't remember the last ER that we actually went up
Added some shares, averaging up a bit. Hopefully we hear something about NDA in the upcoming ER.
Looking for an entry point to play this game with you guys
This chart is asking for good news to break out. Maybe on Friday we will get that opportunity.
I think this company is fraud. At least I didn't put much here. Did they do a stock offering yet? if not it is coming...
Been trading between $2.70 - $3.40 for almost 2 months, any good news sends this higher.
November 17 2022 FDA Adcom
Voted 9-4 in favor as monotherapy, 10-2 in favor as combo therapy.
December 16 2022 FDA Response (30 days)
Peter Stein, M.D., Director of the Office of New Drugs, Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA), requested a meeting with Ardelyx to discuss the status of his review of the appeal. After a productive conversation, Dr. Stein communicated that the FDA is finalizing the response and may require up to a few more weeks to do so. Ardelyx will communicate the response to the appeal once it has been received from the FDA.
December 29 2022 FDA Complete Response Letter
Office of New Drugs (OND), Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA) granted the appeal to the Complete Response Letter (CRL) for the New Drug Application (NDA) for XPHOZAH.
Next catalyst Date ?
I believe the resubmitting of NDA would be a material event and will be PR'd.
Ardelyx to request a meeting with the DCN to determine specific information that will form the basis for resubmission of the NDA for XPHOZAH. Ardelyx will request this meeting as soon as possible to enable the company to resubmit the NDA in the first half of 2023
$3 bucks is cheap for a long hold. Volatility over this past month is pretty high, might be able to get in under $3 if you're patient. IMO
Yes Ibsrela, but being approved for Xphozah is a whole new revenue source. The flawed part is the company has done everything the FDA has asked, they know it works, but they question clinical meaningfulness.
Disregard that message. Company needs to meet with DCN and then submit NDA (again). From there it will take another 6 - 10 months.
In the response letter, OND directed the FDA's Division of Cardiology and Nephrology (DCN) to work with Ardelyx to develop an appropriate label. Ardelyx believes that a label could reflect an indication for patients whose hyperphosphatemia is insufficiently managed on binder therapy. In addition, the letter guided Ardelyx to request a meeting with the DCN to determine specific information that will form the basis for resubmission of the NDA for XPHOZAH. Ardelyx will request this meeting as soon as possible to enable the company to resubmit the NDA in the first half of 2023.
Upon approval, XPHOZAH would be the first and only phosphate absorption inhibitor, offering patients a novel mechanism. Crossing my fingers for this day.
When you guys think we will hear back from FDA?
That $4 sp got to me a little, it made no sense! The A2 data and efficacy was the only thing that made me buy more. Ar dx is on the cusp of fda approval for an already approved drug with different use cases. They had an adcom with positive votes in favor of approval back in November. if approved sales would ramp up quickly. IMO
I thought 2021 was the end. Wish I knew what happened. We know for sure they were in talks and then something broke down. HR VP Glenn got let go (for leak?). The ATM was really bad back then, but now I'm glad he did it. The hiring of Michael https://www.linkedin.com/in/injaychock/ in December 2021 also still sticks out in my mind.
I can't find the article, but it was about another acquisition Caforio did. He was known for doing deep research prior to any takeover. It doesn't get much deeper than having your former executive director in the company you want to acquire. He also negotiated a lower price as that companies stock price was reduced. That might not be possible with AUPH because of the cash (from ATM) on hand and scripts are going up. Not at the pace that we retail would like or I should say that I would like. Our drug is a specialty and it took me a little while to understand this. The expansion in other countries will help with sales moving forward for organic growth.
With the news of settlement and 2022 unaudited fins early. I'm not sure if this is a deal over a year in the making, putting a for sale sign for other companies, or our CEO propping up SP prior to AGM to keep his and BOD's jobs.
But this stock definitely taught me a great lesson on investing. I over extended myself here. I now have a titanium stomach for price swings. I hope we are at the end of the tunnel, but I'm ready to ride the train till it gets there. Good luck to all of us!
All is my opinion not financial advice.
Stacking Sats, DCA! A little early for a bull market...What you guys think?
In so heavy a few pennies hurt!
Let there be light at the end of the tunnel.
The volume since Friday is the float many many times over. How long can they sustain this sp on the darkpool.
The only proof you're showing is your immaturity. Blocked
Agree. I like the accumulation going into the catalyst.
No, you need to do your own DD and come to your own conclusion.
Speculation, but you know its true.
They printing extra synthetic shares today, hoping to buy them back later when its cheaper.