Positive thoughts attract positive vibes
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2 months out from FDA decision. Hoping mono therapy gets approved also.
I call it Educated. I seen the propaganda being shown. Anyways no point in us arguing you're out and I'm in. I will take your luck as a blessing. Cheers.
Not the same. The lawsuits are frivolous, made up to tank the share price.
In at 15. The volatility is equivalent to bio stocks, I fit right in.
AUPH is in a great spot at the moment.
- No debt and $300+ million. Enough to keep the company going for years.
- They solidified the patent.
- The efficacy and safety data is better than it's competition.
- The only FDA approved oral drug on the market
- The board member that was handing options like snow cones on a hot day is gone.
- Strategic review announced end of June
- Revenue ramping up. Increased revenue guidance twice this year.
So many positives in my opinion. GIA will hit $200 million a year in a couple years. BP will hit 200 in a year.
Went from writing calls to buying them. Not much premium on them for Oct/Jan. Might have a chance to hit if we get something out of this strategic review. Gives a few months to make something happen. Good luck all!
Maybe a bad ER will be the last chance to grab cheap shares. When AUPH did that offering back in December 2021 it built a huge cash runway. CEO probably planned on being here for years to collect free options. It also gave the company strength to hold out for higher prices which unfortunately did not materialize. After the AGM board members being voted out is a wake call for him. He needs to sell or risk being pushed out. Come to think of it, maybe he is planning a bad ER to create a phantom premium and allow greedy friends to get in on the cheap. All we know is the company is for sale.
This is going to be ramping up with a dip prior to FDA announcement along with some FUD, then it is going to spike up. Tutes going to dump on retail and move price back down. Then reload. Can play either way as the company will be a good long hold.
Let it end!!!
The hardest money on earth! BTC DCA Long and Strong!
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Bitcoins decisions are already written(white paper). There is no CEO advertising it. Yet you start seeing it everywhere in every country. Why? Because those are the people that understand it. They realize it is greater than their local currency. They are educating why it is better.
It literally is extremely scarce. With all the little retail holders around the world nibbling away at its supply. Unknowingly to most, this is a huge advantage. Big institutions are still navigating a new asset in the investment world. They seek clarity and don’t know if they can invest legally. If Blackrock ETF is approved a monumental shift will occur. A spot bitcoin ETF will be backed physically by the asset. The supply will disappear.
Everyone remembers David for his one win, but Goliath has won many more battles that no one remembers.
I was about to open a position here today because of the declining sp. But something caught my eye while looking at the company overview. The OS has increased significantly. The link below is showing 334m, my broker is showing 345m, that is over 10m more added in a month. 80,000,000!! more shares added since January. Not trying to be a bear, just sharing info. I hope you guys get your squeeze! I will cheer you guys on from the sideline.
https://ycharts.com/companies/GTII/shares_outstanding
Great opportunity to accumulate more. Market cap is at about $780M. Still a little high compared to current revenue. But it’s low for the potential revenue in upcoming years, definitely a long hold. I still think $6-$8 by end of year.
Good info on both posts. Thanks!
Ouch! Sorry to anyone holding.
You was right. But I'm still happy where I left, can't always sell at the top. Good luck!
Would your wife know if Ibsrela is already being prescribed to patients for serum phosphorous? Like an off label prescription.
Interesting. Thanks for the info.
Stock manipulation. But if you want to get technical with the numbers last Q was $11M revs and the market cap is sitting at nearly a billion $. So only sucker retail like me buy these dips in hopes to sell to an even bigger sucker come FDA approval time lol.
Tell MKT to sell they're toxic.
Exited today with 30% gain, only took a couple years of holding through an absolute beatdown.
They probably tallying up the votes and it does not look good for them.
Why would they use debt financing rather than do a share offering? They should have 8k a share offering months ago and then let it run and sell shares into the run. Approval was not guaranteed but at least position the company to take advantage of it.
I though it would have a greater immediate impact on SP.
Agree. It looks fabulous! Would need to tread carefully if it reaches mid teens, market cap would be at $3 billion. Expected is just some number someone made up based on an estimate of possible patients. AUPH had same expected rev and is no where close. But that is not a great comparison since Xphozah is not some specialty drug that needs to go through so many channels. Diagnosis is much easier as patient numbers are taken regularly to monitor their condition.
I sold shares on and bought calls earlier this year which worked out really well. Also added January $2 and $3 calls. Looking forward to exercising those.
Did you add more here? This recovered well from the bottom. I was putting all into ARDX and AUPH, didn't add any here.
Mid November at the latest depending on review time. Once approved (most likely IMO) a share offering is coming to shore up it's bank account. It's going to get negative feedback but they need this money to keep the company financially secure.
Ardelyx announces the resubmission of a New Drug Application to the U.S. FDA for the approval of XPHOZAH for the control of serum phosphate in adult patients with chronic kidney disease on dialysis who have had an inadequate response or intolerance to a phosphate binder therapy
An Acknowledgement of Receipt letter from the FDA, confirming the resubmission is complete, is expected in mid-May. We expect that the letter will include the classification of the resubmission and the review goal date.The NDA is supported by a comprehensive development program that included more than 1,200 patients in three Phase 3 clinical trials evaluating the safety and efficacy of XPHOZAH, all of which met their primary and key secondary endpoints (PHREEDOM, BLOCK and AMPLIFY), as well as two additional Phase 4 open-label clinical trials (OPTIMIZE and NORMALIZE).
Shorts are pilling on us, up to 12%. I hope the mad scramble will be in December, let those $4 shares go long for the tax break.
Settlement Date / Short Interest
03/31/2023 17,277,040
Ouch! sorry bro. That's a huge loss.
Added on this dip. NDA submission coming soon.
There is no challenge, stop bringing this bs topic up. Half the people that take it do no experience it at all. When something gives you diarrhea do you keep eating it? No! It's not for everyone and everyone's body reacts differently.
They didn't see the benefit of using the drug.
The FDA agreed that "the submitted data provide substantial evidence that tenapanor is effective in reducing serum phosphorus in CKD patients on dialysis," according to Ardelyx, but said the treatment effect is "small and of unclear clinical significance."
With that being said they know it works "the submitted data provide substantial evidence that tenapanor is effective in reducing serum phosphorus in CKD patients on dialysis,"
The adcom late last year with testimony from patients and doctors help them understand the benefits. It was voted in favor of approval 9-4 as mono and 10-2 as combo.
Not sure, not a doctor or scientist. But Ibsrela is the same drug. Xphozah would probably have the same recommendations to stop usage. Everyone reacts to drugs differently and it may not be best for everyone. But at least approval will give patients another option to try.
Diarrhea was the most common adverse reaction in two randomized, double-blind, placebo-controlled trials of IBS-C. Severe diarrhea was reported in 2.5% of IBSRELA-treated patients. If severe diarrhea occurs, suspend dosing and rehydrate patient.
MOST COMMON ADVERSE REACTIONS
The most common adverse reactions in IBSRELA-treated patients (incidence ≥2% and greater than placebo) were: diarrhea (16% vs 4% placebo), abdominal distension (3% vs <1%), flatulence (3% vs 1%) and dizziness (2% vs <1%).
INDICATION
IBSRELA (tenapanor) is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults.
Scripts for Ibsrela are steadily climbing and NDA for Xphozah to be submitted to FDA "early second quarter" per CEO. Its retail and institutions accumulating shares.
The proof is in the data.
Up to 49.4% of patients treated with XPHOZAH monotherapy or XPHOZAH in combination with sevelamer achieved a sP level within the normal range during the 18-month treatment period, which is 66.3% better than standard of care, at 29.7%, as shown in DOPPS February 2021
https://ir.ardelyx.com/news-releases/news-release-details/ardelyx-presents-positive-data-further-supporting-efficacy-and
This data is important. As there are many other drugs for the treatment of hyperphosphatemia. But having an additional option for patients is important. What works for some may not work for others.
Accumulation. Those bars are getting really big.