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I will be waiting for the first half hour, dive in and buy more. Can’t argue with the storyline on this drug.
He probably sold them, caused the panic, knew it would and then bought them back and bankrolled the profits. Thats what makes stocks with billions of outstanding shares so volatile.
The drug has everything going for it. This stock will bounce back for sure!
I would say if it proves to be effective against less ill people, it could be used against all people testing positive for the COVID 19 virus and hence would be the “drug of choice” for all Infected. Although it is not a preventative vaccine, it is a cure for all stages of the virus, Stage 1 through Stage 4. “That’s a big deal!”
It than simply comes down to this: “test an individual and administer RLF100.” Hospitals and clinics who have this drug stored on their shelves could cure all those who test positive for CV. People could resume their normal lives knowing a “cure” is readily available should they contract the disease!
Putting it another way: If you have a cure for the virus at any stage, why do you need a vaccine especially if the memory antibodies are developed in the process to fight a future infection. If not, one can still get another dose if they were to get re-infected.
Perhaps I should clarify:
It is a drug or vaccine therapy which can cure for the CV-19. It prevents death from the disease.
I do not believe it can be categorized as a vaccine which can be injected or orally ingested into an individual to prevent that individual from getting the COVID-19 disease.
That’s the difference! That does not in any way diminish its value as a life saving drug
Analogy: It doesn’t stop the mosquito’s malaria infection but can cure the malaria and prevent the death of the infected person.
The infected individual will likely develop antibodies so he should be immune to further infections.
This is my understanding but I am not a medical expert by any means!
The only way it could become a vaccine is if it creates anti-bodies that can attack any future coronavirus infections. It would take further study to determine if it could serve as both. Time will tell as the data comes out!
The difference between a vaccine and a therapeutic vaccine is as follows:
Vaccines are administered to individuals as a precautionary measure to avoid the infection or disease.
A therapeutic vaccine is administered after the individual has already been infected by the disease.
Aviptipal fits the second description. It is designed to save the life of a COVID 19 infected person and this drug is reported to be extremely effective for those in stage 4 or a very serious health situation.
Research will continue to develop a vaccine as a preventative measure.
Bottom line: With the administration of RFL100, aviptipal, the death of a patient can be largely removed from the equation should individuals contract the virus.
That’s six of six seriously ill patients.
Roche with its headquarters in Basel whose flagship drug for treatment of CV-19 is not working, may want to consider RFL as an acquisition! Will be fun to watch this all play out!
Kmack 49
You don’t seem to understand when a gift horse is staring you in the face!
I have seen three men lying face down in ICU on respirators whose lungs are filled with mucous and drowning in their fluids. Nurses can do nothing but watch them die. With RLF-100, they have a means to clear up the lungs and allow a family member’s loved one, the breadwinner survive so he can rejoin his family.
This drug does not yet claim to be a vaccine which works to develop anti-bodies. It is simply a late stage treatment for those who are in extremely critical condition. This drug should be on the shelves of every ICU ward to treat those suffering from extreme COVID 19 respiratory lung infection. With this drug, nurses have a fix that will save the lives of those who might otherwise be terminal. If your a medical practitioner treating serious cases of CV, you would want this arrow in your quiver!
On my opinion, this medication could virtually eliminate the death rates due to CV-19 in hospitals across the country and around the world.
This stock trades on the European Market and last Friday it traded 150M shares. It went up 40% and I expect the stock is geared for a one two punch on Monday as it moves up on both the European and US and Canadian Markets. Just my opinion. I plan to buy more on the opening on Monday. It will not stay below $1.00 very long!
Aviptadil (RLF-100) COVID-19 Therapeutic
Fact checked by Robert Carlson, MD
Aviptadil COVID-19 Therapeutic Description
Aviptadil is a formulation of synthetic human Vasoactive Intestinal Peptide (VIP).
VIP is known to target the VPAC1 receptor of the ATII cell and to protect that cell against all manner of injuries, including smoke inhalation, exposure to stomach acid, and exposure to infectious agents. VIP prevents apoptosis, blocks cytokines, lowers TNFa levels, reverses CD4/CD8 ratio, and reduces cough and dyspnea in nonclinical and clinical studies.
Aviptadil COVID-19 Therapeutic has received orphan drug designation from the US Food and Drug Administration (FDA) in acute respiratory distress syndrome and chronic lung diseases
Aviptadil COVID-19 Therapeutic Indication
Aviptadil COVID-19 Therapeutic is being used to treat Novel Corona Virus (SARS-CoV-2) that is known to cause Respiratory Failure, which is the hallmark of Acute COVID-19, as defined by the new NIH/FDA classification.
Approximately 50% of those who develop Critical COVID-19 die, despite intensive care and mechanical ventilation.
Patients with Critical COVID-19 and respiratory failure, currently treated with high flow nasal oxygen, non-invasive ventilation or mechanical ventilation will be treated with RLF-100 (Aviptadil).
Aviptadil COVID-19 Therapeutic News
August 3, 2020 - According to the companies, the first report of rapid clinical recovery under emergency use of the drug was from Houston Methodist Hospital doctors.
August 2, 2020 - Critically ill COVID-19 patients recovered rapidly from respiratory failure after three days of treatment with RLF-100, a therapy granted fast-track designation in the United States, two drug companies said Sunday.
June 9, 2020 - Relief Therapeutics and NeuroRx have expanded the Phase II/III clinical trial of RLF-100 (Aviptadil) to include Covid-19 patients on ventilators, high flow oxygen, and noninvasive ventilation (CPAP).
Aviptadil COVID-19 Therapeutic Clinical Trials
Clinical Trial NCT04311697: Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure (COVID-AIV)
Clinical Trial NCT04453839: RLF-100 (Aviptadil) Intermediate Population Expanded Access Protocol (SAMICARE)
Patients with Critical COVID-19 and respiratory failure who are ineligible for enrollment in NCT04311697, who live more than 50 miles from an existing collaborating research center, or who are already hospitalized and cannot safely be transferred to a collaborating research facility may be considered for expanded access by the sponsor.
Treating physicians must complete FDA Form 3396 and receive a letter of authorization from NeuroRx, along with local IRB authorization.
Clinical Trial NCT04360096: Inhaled Aviptadil for the Treatment of Moderate and Severe COVID-19 (AVICOVID-2)
SARS-CoV-2 virus infection is known to cause Lung Injury that begins as dyspnea and exercise intolerance, but may rapidly progress to Critical COVID-19 with Respiratory Failure and the need for noninvasive or mechanical ventilation. Mortality rates as high as 80% have been reported among those who require mechanical ventilation, despite best available intensive care.
Patients with moderate and severe COVID-19 by FDA definition who have not developed respiratory failure be treated with nebulized RLF-100 (aviptadil, a synthetic version of Vasoactive Intestinal Polypeptide (VIP)) 100 µg 3x daily plus Standard of Care vs. placebo + Standard of Care using an FDA 501(k) cleared mesh nebulizer.
The primary outcome will be progression to in severity of COVID-19 (i.e. moderate progressing to to severe or critical OR severe progressing to critical) over 28 days. Secondary outcomes will include blood oxygenation as measured by pulse oximetry, dyspnea, exercise tolerance, and levels of TNFa IL-6 and other cytokines.
Updated08/03/2020 - 12:36
They already received fast track approval on June 24th!
I watched the movement of this stock on the Swiss stock market. The stock opened at .80 and immediately after it opened many holders sold the stock. It went down to .51. As the day moved on, the stock continued to move up to .716. This means that even after the drop from profit taking, the stock clawed its way back up. It appears people all over Europe have gotten wind of this stock as the volume was enormous (150 million) matching some of the heaviest days in the OTC market here at home.
This stock is very resilient. Even after the big sell off in the early morning, more buyers came in as the day wore on.
As for the market action in the US, this was Friday. I would call it “Freaky Friday” or “Consolidation Friday!” The stock wanted to move up but every time buyers put in a buy it was countered with a huge block of shares by selected MM’s on the ask. This happened repeatedly and the stock was prevented from moving up. This coupled with the fact that it was a low trading day I believe caused it to drop into the .62 range.
I expect on Monday it will rebound on the European Market as European buyers come in to snap up the shares. I am fairly certain when the market opens on Monday morning, it will gap up and go well beyond the Thursday closing price of .80.
After watching the action in Europe, and the actions of the MM’s, I believe this stock has a lot more room to grow! I am long on this stock!
No bid or ask on Ameritrade!
No bid or ask on OTC Pink Sheets!
Strange!
Was trading halted?
Only 682 posts means this stock has not been around very long or has been under the radar.
This stock is highly volatile and moves in both directions with lightning speed. Stock is still being assessed by Investors and as more see what this Gem has to offer (curing late stage critical Covid-19 patients on respirators, it will move up fast and furious!
Sounds like a plan! Thanks!
This small Pharma stock is listed with the BP companies having a potential vaccine for CV-19. That is a good reason to be in it. RVVTF, IPIX, and RLFTF are small companies fighting for recognition in the COVID Arena. All companies have good potential and have great products for the treatment or cure of CV-19. They simply don’t have the deep pockets of big Pharma or the connections.
The need for cures and treatment is beginning to break down those barriers. Going to play all three and try to balance my positions!
This small Pharma stock is listed with the BP companies having a potential vaccine for CV-19. That is a good reason to be in it. RVVTF, IPIX, and RLFTF are small companies fighting for recognition in the COVID Arena. All companies have good potential and have great products for the treatment or cure of CV-19. They simply don’t have the deep pockets of big Pharma or the connections.
The need for cures and treatment is beginning to break down those barriers. Going to play all three and try to balance my positions!
News is Great! Those Covid 19 patients on respirators administered the drug recover in a few days. Also CYDY went to $5.00 with similar OS count.
Want to buy more but need another day for one of my stocks to run the three day waiting period. Probably get to 50 cents before I can buy some more.
Should have bought RLFTF. I bought both and should not have split the money between these two!
RLFTF was up 500% just 29 minutes before the close but ended the day only up 390%.
This stock is beginning to percolate. Anticipate something good is about to happen. Hopefully the long wait for this to start moving up will soon be over!
Shaking out the weak hands. This will go much higher next week!
May be the FDA approved test kit by Scanwell.
Breaking News!
Licensed Pharmacists authorized to test for corona virus.
This will expand testing and provide easy access to all those who want or need to get tested.
Go PRED$$$$
They need to sell that building they own. Cash out and buy back shares or expand their headhunting business.
Haven’t heard a word from this company about their plans. Why? Because they have no plan!
Agree! AVXL 2-73 extends the time one gets severe symptoms caused by AD and reduces the care cycle and expenses family members have to endure for a loved one.
A little dated but still an interesting read!
We are always, always tempted by anything that promises hope to sufferers of Alzheimer’s Disease and their families… not just because we’re humanitarians and love people, and have seen the pain of this disease, but because Alzheimer’s treatment is by far the largest (mostly) unmet medical need in the US, both because the population of at-risk people is so high and because the current treatments are largely ineffective for most of those people, and a cure or drug that provides meaningful improvement to patients would be worth billions of dollars.
Unfortunately, it has become an axiom that “Alzheimer’s Disease drugs fail in Phase 3” — while roughly 90% of all drugs fail to get approved according to most estimates, the metric for this particular disease is a far more discouraging 99.6%... and many biotech and pharma companies have put billions of dollars into Alzheimer’s Disease research just to see their treatments fail in the last wave of clinical trials, either because those drugs turn out to not be effective in large cohorts like they were in smaller groups, or because nasty side effects turn up once you increase the size of the trial.
The FDA is focused on trying to encourage new Alzheimer’s Disease drugs, including policies that may speed up trials, but they’re also quite cognizant that any effective drug that gets approved, particularly if it’s an early-stage preventive drug, could be used in millions of people in pretty short order. Everyone over 60 is worried about Alzheimer’s Disease, and there are an estimated 5+ million people with the disease already… with many more likely coming as the baby boomers surge into their prime Alzheimer’s-risk years (the Alzheimer’s Association says one in ten folks over 65 will develop Alzheimer’s dementia).
So that’s the landscape we’ve lived in for decades now — there’s huge wealth to be made, and huge social benefit, in an effective treatment for Alzheimer’s Disease… but we’re still not 100% sure what causes it or what an effective treatment will look like, and the clinical trials depend on squishier data like psychological assessments that lend themselves to huge placebo effects. But that “huge wealth” part keeps investors looking and hoping… and it keeps newsletters hinting and promising.
And it’s one of those piles of hints that we’re looking at today — this time, it’s a pitch from Chris Wood in an ad for Casey’s Extraordinary Technology ($2,000/yr). Here’s how the ad gets us revved up:
“Until now, Alzheimer’s has had a 100% fatality rate. But a new brain-boosting drug called ‘Sig-1’ actually reverses it.
“Here’s how you can get an early-in on the tiny biotech company that has the exclusive rights to this groundbreaking drug and score 1,500%-plus gains…”
What, then is Sig-1, and what’s the company Wood is hinting at for 1,500%-plus gains? Here are some more clues:
The entry is the story of a woman named Betsy, who was diagnosed with Alzheimer’s Disease and enrolled in a clinical trail for this “Sig-1” ….
“… amazingly, after 9 months of participating in the study and taking “Sig-1,” she regained her ability to play the piano….
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“The results were miraculous.
“Her doctors were stunned…
“For the first time in an Alzheimer’s clinical trial, a patient had regained a skill that was lost to this horrific disease.
“Major media outlets called the results, ‘amazing,’ ‘game-changing,’ and ‘spectacular.’
“With the remarkable results showing the first major improvement in treating the deadly disease since the 1990s.
“Betsy’s friends and family were ecstatic…
“Wiping away tears of joy, her husband said, ‘I have her back.'”
And apparently it wasn’t just a few patients who regained their ability to play piano (or paint, or play golf, or whatever), the drug was at least benign for everyone… more from Wood:
“… this drug either slowed or reversed Alzheimer’s in every single patient in the trial.
“And more good news… clinical results showed ‘Sig-1’ to be safe and well-tolerated.
“Finally, with this revolutionary new Alzheimer’s drug… there is hope for a long-awaited cure.”
We’re told that this drug does something a bit different from the high-profile flops that we’ve seen in the Alzheimer’s arena in recent years…
“… in recent decades, scientists have focused their Alzheimer’s efforts on drugs that reduce the sticky plaque known as amyloid in the brain.
“A plaque which is believed to contribute to the development of Alzheimer’s by stopping the brain from functioning properly.
“And as the Financial Times reports, “Drug makers have spent billions of dollars developing new medicines designed to remove the plaques — even after a succession of high-profile failure…”
“Including recent failures in large Phase 3 studies done by Pfizer, Eli Lilly, Roche, and Merck.
“But ‘Sig-1’ uses a different approach to treating Alzheimer’s from these big pharmaceuticals…
“Instead of targeting amyloid plaque, it looks to restore the balance and healthy processes of a cell.
“Because as people age, a special protein that is located in many different types of cells stops working as well as it used to.
“And in people with Alzheimer’s, it stops working almost completely.
“‘Sig-1’ acts like a chemical switch and turns the special protein back on, which removes the abnormal proteins that scientists think could cause Alzheimer’s from within a cell.
“The result… a significant slowing – and even a reversal – of the long-term effects of Alzheimer’s.”
So that’s the big picture — this drug doesn’t go after those plaques, but does something different… and it’s not so hard to guess that Sig-1 refers to Sigma(1) receptors, which will mean something to those of you primed in neuropharmacology (I’m not, in case that’s unclear).
So what else do we learn about this stock or this treatment? More clues…
“Right now, this tiny biotech is in the process of planning its Phase 3 clinical trial for ‘Sig-1’… the final stage the drug must go through in order to be get FDA approval….
“Setting this company on a course to capture a sizable share of the projected $20 billion Alzheimer’s drug market in short order… and potentially bringing you gains of well over 1,500%.”
Then he gets more specific with his “dream of a fortune” forecast:
“… it would only take this tiny biotech to capture a mere 10% market share of the projected $20 billion Alzheimer’s drug market to become a $2 billion a year blockbuster.
“And with a conservative sales multiple of 2 – well below the usual industry multiples of 2.5x to more than 5x – you’re still talking about a potential $4 billion market cap for this company, which could jump the stock price to over $96 per share.
“With today’s stock price for this tiny company falling below $5.50 per share, that’s a monster 1,500%-plus potential gain for this tiny biotech.
“Which could turn a small $10,000 investment into over $160,000.”
And, apparently, it’s not just Alzheimer’s Disease that this “tiny company” is addressing — they are also showing promise and receiving research grants for Sig-1 treatments for Parkinson’s Disease, Epilepsy, Multiple Sclerosis, and Rett Syndrome… and the company actually is entering or about to enter Phase 2 clinical trials for Epilepsy and Rett Syndrome, which gives them, we’re told, another catalyst well before Alzheimer’s Disease trial results start to come in…
“The Next Major Catalyst for this Tiny Biotech Could Occur as Early as December 2017
“With cash on hand of over $23 million and no long-term debt, this company has a solid financial foundation to continue its research and development for years to come…
“With enough cash to take it through two significant value-driving catalysts that are funded and ready to begin…
“A Phase 2, 12-week trial for Parkinson’s disease… with expected results as early as December 2017…
“A Phase 2, 12-week trial for Rett syndrome… with expected results in late 2017/early 2018…”
OK, so we’ve really loaded up with clues there for you… any guess as to who this is? You in the back? Yes, you’re right! This is indeed, once again, the oft-teased Alzheimer’s Disease darling Anavex Life Sciences (AVXL).
Anavex is developing several drugs, but the lead candidate is currently Anavex 2-73 for Alzheimer’s Disease… and those stories about the elderly woman returning to the piano, and the painter regaining her skill, are from the Phase 2a trial they did in Australia starting in the fall of 2015 — it got a lot of press at the time, and that trial is continuing (a 104-week followup should be available by the end of the year), but the next big possible news is Anavex actually launching the next clinical trial, which they say will be a pivotal phase 2/3 trial with hundreds of patients.
Anavex, in part because of its fairly rare combination of promising early stage results and small market cap, is both a perennial teaser target and a lightning rod for investor debate. It has come up in the pages of Gumshoe more times than I can count. The first pitch I saw for it was in 2010, back when it was a $75 million OTC stock, and teaser pitches have come through for the shares an average of at least once a year or so since then (though most of them have been from Agora Financial, with Michael Robinson and Ray Blanco being probably the biggest boosters).
Before today’s piece, I’d say the most irresponsible and dramatic one was Ray Blanco’s pitch for Anavex in the Fall of 2015 that implied the stock would be surging to new wealth-creating heights starting on a specific date just a few weeks after the Phase 2a trial for Anavex’s lead drug was enrolled (his attention helped to drive the shares up from a $100 million market cap to, briefly, over $400 million… though it was right back down at $100 million or so a week or two later).
This time around there’s no promise of a specific date from Chris Wood in his ad for Extraordinary Technology, just that the December results of their less-important clinical trials will generate more attention toward the end of this year, and that enrolling their Phase 3 Alzheimer’s Disease trial will get investors excited (especially if the Phase 2 results from Epilepsy and Rett Syndrome provide more positive safety news)… but at least we’re not looking at a single do-or-die date.
Still, $23 million is not very much money when you’re talking about running a Phase 3 trial for Alzheimer’s Disease (it’s actually closer to $25 million as of June, they sold some more stock last quarter). The Phase 2a study that showed those exciting results included just 32 patients, the next planned study, a pivotal Phase 2/3 trial, is expected to have perhaps 300 patients according to the notes I saw on the company website… and it’s hard to imagine a company getting broad approval, even with the FDA’s interest in advancing Alzheimer’s drugs, without a real 1,000+ patient Phase 3 trial or two after that.
The company has an investor presentation here that was last updated in June, and they do indicate that they’ll have some “potential for clinical read-out by end 2017/early 2018”, presumably on their Phase 2 trials in Rett Syndrome and Parkinson’s (those will have data fairly quickly because they’re 12-week trials — though their latest quarterly press release indicated that those potential “read-outs” are 2018 events, not 2017). There will also be another wave of updates on the Phase 2a Alzheimer’s study — the study that included those headline patients who regained the ability to play the piano and paint. That cohort has been followed for another year, so there will be 104-week extension data available at some point… if it follows the schedule of their past release, then that data would likely be reported by December (the 57-week data was reported last December).
It all sounds quite hopeful, and I certainly join pretty much everyone in hoping that this early-stage promise turns into a safe and effective drug someday… but I’m perhaps more skeptical than most about Anavex because that Alzheimer’s hope has been teased for such a long time and development has been so frustratingly slow. I am not at all an expert on the pharmacology or the neurology here, and can’t tell you where the real opportunities or pitfalls might be for Anavex 2-73, but this is what I wrote back when Ray Blanco was pitching the stock in the Fall of 2015:
“If past Alzheimer’s drug hopes are any indication, there are four scenarios I could guess at: A, it could collapse on the next news release or sometime in the current trial because of bad news; B, it could consume a couple hundred million dollars running a big phase 3 trial and fail to show good results because of poor safety or lacking efficacy, and see the share price drop on bad news and capital raisings over several years; C, it could attract a suitor if they get “phase 3 ready” and get bought out or partnered to cut costs, driving the shares up further; or D, it could, maybe sometime early in the 2020s after another 5 years of clinical trials, eventually get approved and be the cure everyone’s looking for. My guess is “B” … but, as I noted above, I may be too cynical on this one and it has certainly gotten some folks excited so far this year.”
No scary safety concerns have come up to my knowledge, so “A” has been avoided thus far (though, I hesitate to remind you, only a few dozen people have ever been treated with Anavex 2-73, so we’re far from assured of safety — let alone the elusive “effectiveness” hurdle that has thwarted so many drugs)… but my assessment as a non-expert who rarely dabbles in biotech stocks is still more or less the same. The possible gains for Anavex stock if they have great results in the larger Alzheimer’s trial they’re currently planning, are incredible… but the possible gains should be incredible if you’re talking about an arena where the probability of success is very low. If you want to wager on Alzheimer’s Disease drugs just keep that in mind: Risk high, reward high.
Maybe those of us who are cautious about Anavex are overstating the importance of the historically high failure rate of Alzheimer’s drugs or the continuing debate about the nature of the disease itself, and maybe Anavex will have that special angle on this disease that allows them to unlock something remarkable… that’s always the hope of a biotech drug candidate, though the risk-reward calculation is amplified for Alzheimer’s drugs. I don’t have the scientific expertise to give me any hope for an edge in making a call on Anavex — perhaps Chris Wood does, I don’t know — so I’ll stay out of the game. If you’ve got an opinion or some insight on this company or this drug, please feel free to shout it out with a comment below. Thanks for reading!
The phase III trials involve 1000 to 3000 participants and when a drug reaches this stage in the trials, there is a very high probability it will succeed in making it to market. The future for AVXL for the treatment of AD looks very promising!
Dream On!
The pulse of this stock is one beat every 24 hours. It is effectively a “dead stock” and all those invested in it are sitting on “dead money!”
Where are the announcements? Awfully Quiet!
Placing a $10M bet on a penny stock means someone has put their faith in the outcome of this company. Rarely happens in the world of the penny stocks!
Off to the races! Stock will double today.
Picked up 160000 shares @ .0101 yesterday. Going to try to get some more in the AM.
I noticed Quad M solutions who merged with PR 345 who some claim is actually GXXM just signed a letter of intent to buy Meritra Healthcare located in Columbus Ohio in a deal in exchange for cash and stock. Is it possible that Quad M is diluting the shares of PR345 aka GXXM for this acquisition? Don’t know if this might explain the dilution. Don’t know if it would be legal to use the shares of a shadow company to buy another company. The fact they have kept the shareholders here in the dark is bothersome.
Innd will emerge as “Best In Class”. There are loads of car companies after the market but certain suppliers evolve as the best, Honda, Toyota Ford and Lexus for example
If 237 million shares are owned by insiders and the stock goes up due to the merger or acquisition, they tend to become mega millionaires overnight which in my mind is a compelling reason to make it happen.. Many of those shareholders here will also stand to gain big time. At the current SP, no one holding this stock should even think about selling til the news is out!
Where’s the guy who posted yesterday stating: “We will never see the low two’s again.” Maybe he should have held his remarks til after today’s super performance!
Mmmm filed on May 14 disclosing their projected income from their mining operations. Projections look very good. Check it out on the OTC markets. Good news for shareholders who are holding here.
Dorvil is brilliant. He is a motivational speaker and former board member of GEX Management. He built the company and will play an even greater role in the upcoming merger. He appears to me to be a stand up guy with a good reputation!