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Another good article on covid's sometimes longer-lasting effects (mostly on the unvaxed, it seems). Why in the world would folks choose not to get themselves and their children vaccinated/boosted? Is this an example of natural selection working its magic with humans? Almost seems like.
"Would it surprise you to find that the one guy they featured as an example had a few non-Covid related problems? Sure wouldn't surprise me"
Me either.
New, NYT Research (Today's edition) on the likelihood of contracting Long Covid. Is there a place for B here, sure is imo. Is it likely that Leo and company will give it a shot, you be the judge.
New Research Hints at 4 Factors That May Increase Chances of Long Covid
If further study confirms the findings, they could lead to ways to prevent and treat the complex condition.
John Gillotte was infected with Covid in March 2020 when he was living in Seattle. He was hospitalized and on a ventilator for several days and experienced long Covid symptoms that lasted for months.
John Gillotte was infected with Covid in March 2020 when he was living in Seattle. He was hospitalized and on a ventilator for several days and experienced long Covid symptoms that lasted for months.Credit...Joshua Bright for The New York Times
Pam Belluck
Jan. 25, 2022
Leer en español
It is one of many mysteries about long Covid: Who is more prone to developing it? Are some people more likely than others to experience physical, neurological or cognitive symptoms that can emerge, or linger for, months after their coronavirus infections have cleared?
Now, a team of researchers who followed more than 200 patients for two to three months after their Covid diagnoses report that they have identified biological factors that might help predict if a person will develop long Covid.
The study, published Tuesday by the journal Cell, found four factors that could be identified early in a person’s coronavirus infection that appeared to correlate with increased risk of having lasting symptoms weeks later.
The researchers said they had found that there was an association between these factors and long Covid (which goes by the medical name post-acute sequelae of Covid-19, or PASC) whether the initial infection was serious or mild. They said that the findings might suggest ways to prevent or treat some cases of long Covid, including the possibility of giving people antiviral medications soon after an infection has been diagnosed.
“It’s the first real solid attempt to come up with some biologic mechanisms for long Covid,” said Dr. Steven Deeks, a professor of medicine at the University of California, San Francisco, who was not involved in the study.
He and other experts, along with the study authors themselves, cautioned that the findings were exploratory and would need to be verified by considerably more research.
Still, Dr. Deeks said: “They’ve identified these four major factors. Each is biologically plausible, consistent with theories that other people are pursuing, and importantly, each is actionable. If these pathways get confirmed, we as clinicians can actually design interventions to make people better. That is the take-home message.”
One of the four factors researchers identified is the level of coronavirus RNA in the blood early in the infection, an indicator of viral load. Another is the presence of certain autoantibodies — antibodies that mistakenly attack tissues in the body as they do in conditions like lupus and rheumatoid arthritis. A third factor is the reactivation of Epstein-Barr virus, a virus that infects most people, often when they are young, and then usually becomes dormant.
The final factor is having Type 2 diabetes, although the researchers and other experts said that in studies involving larger numbers of patients, it might turn out that diabetes is only one of several medical conditions that increase the risk of long Covid.
“I think this research stresses the importance of doing measurements early in the disease course to figure out how to treat patients, even if we don’t really know how we’re going to use all that information yet,” said Jim Heath, the principal investigator of the study and president of the Institute for Systems Biology, a nonprofit biomedical research organization in Seattle.
“Once you can measure something, then you may be able to start doing something about it,” Dr. Heath said, adding: “We did this analysis because we know patients will go to physicians and they’ll say that they’re tired all the time or whatever, and the physician just tells them to get more sleep. That’s not very helpful. So, we wanted to actually have a way to quantify and say that there’s actually something wrong with these patients.”
The complex study had several components and involved dozens of researchers at several universities and centers, including the Institute for Systems Biology, the University of Washington and Swedish Medical Center in Seattle, where the study’s lead medical author, Dr. Jason Goldman, is an infectious disease specialist.
The primary group of patients included 209 people, ages 18 to 89, who were infected with the coronavirus during 2020 or early 2021 and were seen at Swedish Medical Center or an affiliated clinic. Many were hospitalized for their initial infections, but some were seen only as outpatients. Researchers analyzed blood and nasal swabs when patients were diagnosed, during the acute phase of their infections and two to three months later.
A tattoo of the demon Mr. Gillotte hallucinated during the Covid delirium he experienced after he was taken off the ventilator.
A tattoo of the demon Mr. Gillotte hallucinated during the Covid delirium he experienced after he was taken off the ventilator.Credit...Joshua Bright for The New York Times
They surveyed the patients about 20 symptoms associated with long Covid, including fatigue, brain fog and shortness of breath, and corroborated those reports with electronic health records, Dr. Heath said.
The Coronavirus Pandemic: Latest Updates
Updated
Jan. 29, 2022, 7:40 p.m. ETJan. 29, 2022
Jan. 29, 2022
New York coronavirus cases fell by 50 percent in the past week.
For those with underlying conditions, an Omicron infection can be anything but mild.
Two Long Island nurses made more than $1.5 million in a fake vaccine card scheme, prosecutors say.
He said that 37 percent of the patients had reported three or more symptoms of long Covid two or three months after infection. A further 24 percent reported one or two symptoms, and 39 percent reported no symptoms. Of patients reporting three or more symptoms, 95 percent had one or more of the four biological factors identified in the study when they were diagnosed with Covid-19, Dr. Heath said.
The most influential factor appeared to be autoantibodies, which were associated with two-thirds of the cases of long Covid, Dr. Heath said. Each of the other three factors showed up in about a third of the cases, he said, and there was considerable overlap, with several factors identified in some patients.
The researchers corroborated some of their findings in a separate group of 100 patients, many with mild initial infections, from research led by Dr. Helen Chu at the University of Washington. The researchers also compared their results to data from 457 healthy people.
“The study is large and comprehensive and is a great resource for the community studying long Covid,” said Akiko Iwasaki, an immunologist at Yale, who was not involved in the research.
Dr. Avindra Nath, who is chief of the section on infections of the nervous system at the National Institute of Neurological Disorders and Stroke and was not involved in the study, called the study well designed but pointed out several weaknesses, including the fact that patients had been followed for only two to three months. “This might be too short a time frame,” he said. “Some might just improve spontaneously with time.”
Dr. Iwasaki noted that 71 percent of the patients in the primary group had been hospitalized, limiting the ability to conclude that the biological factors were equally relevant for people with mild initial infections.
The Coronavirus Pandemic: Key Things to Know
Card 1 of 4
Omicron in retreat. Though the U.S. is still facing overwhelmed hospitals and more than 2,500 deaths a day, new cases are falling rapidly across the country. But experts warned that spotty immunity and the threat of new variants mean the virus is not likely to ever completely disappear.
Covid shots. More than 10 billion vaccine doses have been administered globally according to the University of Oxford, though distribution is uneven. The Centers for Disease Control and Prevention said that third vaccine shots reduced the hospitalization risk for immunocompromised people.
Around the world. Pope Francis warned of a growing “infodemic” based on fake news about the coronavirus, urging Catholic journalists to build bridges with those misled by false reports. A convoy of truckers protesting federal vaccine mandates descended on Ottawa.
Staying safe. Worried about spreading Covid? Keep yourself and others safe by following some basic guidance on when to test, which mask to pick and how to use at-home virus tests. Here is what to do if you test positive for the coronavirus, and if you lose your vaccination card.
One persuasive conclusion, several experts said, was the suggestion that because patients with high viral loads early on often developed long Covid, giving people antivirals soon after diagnosis might help prevent long-term symptoms.
“The quicker one can eliminate the virus, the less likelihood of developing persistent virus or autoimmunity, which may drive long Covid,” Dr. Iwasaki said.
That some patients had reactivated Epstein-Barr virus also made sense, Dr. Nath said, because other diseases have reawakened that virus, and its reactivation has been linked to conditions like chronic fatigue syndrome, which some cases of long Covid resemble, and multiple sclerosis. Dr. Deeks said it might be possible to give antivirals or immunotherapy to patients with reactivated Epstein-Barr virus.
There were other intriguing findings that experts said needed more substantiation. One was a suggestion that because people with lingering respiratory problems had low levels of the stress hormone cortisol, they might benefit from cortisol replacement therapy, which Dr. Heath said some doctors were already trying.
In another finding that he said might provide a way to document that patients’ neurological symptoms resulted from long Covid, the blood of people with lingering neurological issues contained elevated levels of proteins associated with disrupted circadian rhythms and sleep/wake cycles.
One patient in the study’s primary group was John Gillotte, 40, a software engineer who contracted the coronavirus in March 2020. He was on a ventilator for about six days, after which he experienced delirium in the hospital when he closed his eyes.
“I saw the devil, who was like 50 feet tall, screaming at me, throwing limbs that he dismembered off of other people,” recalled Mr. Gillotte, who later had an image of the demon tattooed on his right arm, with depictions of hell below and heaven above to symbolize his progress from illness to recovery.
Mr. Gillotte, who moved from Seattle to Manhattan last year, said that for several months after his infection, he had experienced muscle weakness, lack of stamina, brain fog that impaired his concentration at work, an altered sense of smell and the perception that most food tasted like ashes.
He said that before Covid, he had a spontaneous ability to visualize specific colors with certain foods — pink when he sprinkled pepper, blue with a type of liquor — but now, he is dismayed to have lost those automatic connections.
Mr. Gillotte said he doesn’t have diabetes and didn’t know if he had the other three factors because researchers said the study protocol prevented them from disclosing data about participants.
Dr. Heath, however, noted that Mr. Gillotte had been reinfected with the coronavirus in October 2020, which might reflect one theory that emerged from their study: that patients with higher levels of autoantibodies had lower levels of protective antibodies against the coronavirus, possibly making them more vulnerable to reinfection.
Dr. Deeks said lower protective antibody levels could also be a pathway leading to long-term symptoms. “If you don’t have a good antibody response, you don’t clear the virus; you have more virus around, and that leads to more long Covid,” he said.
Still, Dr. Heath said that overall, the research had showed that the four biological factors intersected and overlapped, suggesting that there might be relatively straightforward ways to forestall long Covid early on. Months later, “all these vague symptoms are so hard to track down, because you’ve sort of lost that information, but if you look back when those symptoms are first triggered, it actually looks like it’s manageable.”
Pam Belluck is a health and science writer whose honors include sharing a Pulitzer Prize and winning the Nellie Bly Award for Best Front Page Story. She is the author of Island Practice, a book about an unusual doctor. @PamBelluck
A version of this article appears in print on Jan. 30, 2022, Section A, Page 18 of the New York edition with the headline: New Research Hints at 4 Factors That May Increase Chances of Long Covid. Order Reprints | Today’s Paper | Subscribe
"NIH combo trials?.."
At the risk of being called or thought of as a nay sayer, what really bothers me is that it is very likely that BARDA, NIH, some Florida hospitals, and lots of other institutes and universities probably have at least a passing awareness of Brilacidin. And no one but Alfasigma has bitten (TG for that at least). Either Leo is not such a good salesman or BP, etc. is just not impressed. What other reasons for this anemic pps? Yeah, I know B for ABSSSI could very likely be successful with a 34 million (or more now, no doubt) capital infusion, but what else? Sure not Kevetrin, which seems to have fallen off the chart. It is very frustrating to sit here and see the time value of the potential products dwindle, along with our portfolio values.
I don't know what is going on. That said, imo we are seeing the results of routine MM head fakes whereby they set a higher pps, a volume boost usually follows, they then short out of their personal account, and even draw some "new Money" or rather money from existing longs or even day flippers. If we don't see any real good news in the next day or two, the MM explanation seems as good as any. There are few to no really big players here, imo. Even a million shares traded can be bought for $50,000. Lots of money to many of us here, but not what you would call a big boy, smart boy trade, though two or three wash and wear trades in a day could net $10-20,000 if well timed.
Thanks, Lemoncat, lots; as long as I've owned this company, I have not used all 4 sites. Appreciate you're not pointing up my rather slipshod dd methods.
Thanks, thought I did, maybe Leo blackballed me for my skeptical comments.
Sorta kidding.
MackG, where did this appear?
Great stuff, many thanks.
Thanks for adding it.
"Makes me wonder how doctor's offices, clinics and infusion suites will deal with the patients who come into a facility used for other things (typically some kind of chemo) knowing that these new visitors have a very contagious disease."
I agree with this all. Just answered my own question. I guess home based IV is now a growing industry. See below:
Vital Care - Infusion Therapy Start Up
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Be a Part of The Booming Infusion Industry. Get Accreditation, Setup & Growth Support. See the growth of Vital Care infusion franchises and why they won't stop growing. Download Free Report. 100% Support. Great Time to Invest. Steady Growth. Attractive Economics. Brands: IV Rx Franchise, Home Infusion Therapy, Infusion Suites.
The "new" home-based infusion sites answer your concern about having facilities that mix covd patients with others getting IV treatment for other reasons.
Thanks for your candor. I really appreciate it.
"I bought more today"
Williamssc, if you allow me to be really nosy, what specific compounds or uses are you basing your confidence on. I almost bought some today myself, and then I didn't, wondering, what specifically am I doing this for. I was not able to answer my own question that well.
Until recently I have not thought much about Leo and company's salaries, figuring the many opportunities for success would have it all come out in the wash. Not so sure now. Admittedly, I keep wondering "what if." For example, if $200,000 or so were spent each year to main a small lab with a couple of post docs (they are cheap, and good). No, I am not referring to contagion or other in vivo experiments, which call for more costly infrastructure, but a small lab that could review various treatment options, various in-vitro paths, co-therapies. etc. You either do this in your own lab, "rent" out others or don't really do it. Would this mean substituting hard, physical efforts/experiments for expert opinion. I just don't know.
Appreciate that! it would be great if IPIX could provide early treatment for covid in all its coming variants.
Sorry, you beat me to the punch, or whatever.
WTF? (From Inside Business)
A landmark Israeli trial is expected to show that four shots of vaccine didn't stop infection by the Omicron variant, according to a study official.
While the extra dose — of either Pfizer or Moderna vaccine — seemed to have some effect, rates of infection among those with four doses were not substantially different from those who had three doses of Pfizer, the study official said.
Gili Regev-Yochay, a lead investigator on the study, told reporters that "the vaccine is excellent against the Alpha and Delta," but the study found that "for Omicron, it's not good enough," The Times of Israel reported Monday.
The investigator did not release data from the trial, noting that the results are preliminary. But she said she shared the early findings as there was a large public interest, according to The Times of Israel.
"Obviously there's no rebound coming."
AlfaSigma provides a few opportunities for rebounds. There are others, but to disregard this one is short-sighted, imo.
"Consider the possibility that his goal was to conduct a trial, any trial"
Well said.
Frenchie, I don't really disagree with anything you say with the exception that Leo stuck with an IV which froze Brilacidin out of pre-facility use. I took the chance as so many of us did, but Leo could have given himself and us a better chance with a treatment method that did not require facility based treatment. Obviously I thought it was a bad move then, and still do. But I felt it was worth the risk.
Can we agree that Leo, either following advice, ignoring it or misconstruing it, put Brilacidin into a place where its IV treatment meant that it was addressing much sicker, hospitalized patients than it would have if an injection or other treatment mode were used, outside of the institutional setting (of course we are not even sure if these would have worked). But it was his choice regarding not spending money to develop those options. I took the chance, as so many others did, knowing full well it would have been a better chance if treatment were much earlier in covid's disease progression. I (we) have no idea what part DeGrado's advice or lack of it played in Leo's fateful decision.
I'm nor trying to be argumentative, but a board member is not a staff member. Of course as a board member he can give advice, and I hope he does, but being paid staff is a whole other thing.
"A promising compound completely mishandled by a CPA and a non-clinician….."
How right you are. Today's New York Times (I could not pull the front page article) featured a complex, multi-page piece on MRA technology as the fount of the present coved vaccines, and the future ones that will be coming. So much to know about virology, the research establishment, MERS and everything in-between. How is our accountant, who lacks a staff of appropriate advisors able to navigate this complex morass of things to know. He can't. His lack of viral/medical/pharmacological background is the reason IPIX seems to stumble from one area to the next, never quite hitting the sweet spot, but still getting paid. Bright enough to corral some key compounds, ignorant enough not to really know how to develop them or negotiate appropriate partnerships/licenses (but for one, so far). Of course maybe Brilacidin and Kevetrin are just not that effective (though I really believe they probably may be), we may never know. Silence is golden when you are on the payroll and not required to do much of anything.
"I'm waiting patiently for the secondary data and CU data that shows Brilacidin's magic but yet another week has passed in silence."
I've kind of given up on that. Each passing day makes the "zero chance" position more likely.
That's all we need. More variations.
"Now that vaccine mandates have been deemed unconstitutional"
Jeez, how f/n stupid was that?
Some science guy longs and some just investors have long believed there is a decent chance that Brilacidin has some real potential here. But lots of BPs looking too, we seem to be toward the back of the line. Is it fair to moan at Leo for not following up on the B for ABSSSI potential? I think so, the time is now for the need to be going viral (bad choice of words!) and we do not seem to be in the hunt. Let's wish Leo luck in his endeavors, as he has no doubt seen what we all are seeing.
Problem is that honest criticism or comments that unearth what seem to be less than ideal decision making are not bashing. It just is what it is.
It is hard to be balanced. The extended uses of Brilacidin, including as a substitute for colistin was fought out on this as well as on the old Yahoo board more than a few years ago. Unfortunately, Leo felt that $34 million was too much to do the Ph3 on B for ABSSSI, which may have led to additional antibacterial uses of B, as well as extended interest in the anti-bacterial uses of B. Leo may be aware of limitations of B of which we are unaware, but we longs will not likely be clued in if that is so, imo. On the other hand, the "no money honey" reason seems most likely as a reason for tabling the use of B for ABSSSI conditions. This was a shame, as pill treatments for ABSSSI are now available, and B sits there as an IV. The pattern of leaving key questions unanswered remains.
You really know how to hurt a guy.
Or an injection. But shell companies don't have small labs and don't do internal work to develop alternative treatment methods.
I am afraid I am afflicted with IPIXitis. I am considering buying 40,000 shares or so of IPIX on Monday. And all for around $2,000.00. I am not rich nor am I poor, and kept averaging down at a few of the many lows. I look at the possibilities, still there but shrinking, imo, and would be happy to bail at $1 per share, or even way less, now that I am more averaged down. WTFKs. I don't. GLT all longs.
Ok, did I misread that 15 million as opposed to 150 million, guess I have my answer. Leo, love'm or leave'm. He is it.
If Leo and board/family shares are totaled up at less than 15 million or so (I have not done an exact estimate) how hard would it be simply outvote them and get a new CEO, etc. How can share owners oust him/them? I was never hugely bothered by the million or more on annual salaries, and failures in the prurisol and covid trials (despite my feeling that an injection addressing early phase patients instead of very sick ones on IVs, would have been so much more reasonable) when the many potentials remained realistic. What has bothered me has been the lack of creativity and verifiable forward motion (still no injection, pill or other treatment variants so necessary to compete in the various markets (IBD, skin, anti-MRSA bacterial, wide-scoped anti-virals for Brilacidin, etc.), not even mentioning kevetrin. And we continue to endure the constant time loss of patent value with almost embarrassing PRs. Couldn't message board longs martial 20-30 million shares? I've heard this mused about with other troubled little bios, but I've never seen anything happen. But here we are at a nickel a share and only the Alfasigma tests as a real potential. And there is no certainty here, only a good chance of good things happening, i.e. FDA test cycle participation. I know B for OM could happen, but there is nothing of substance of which I am aware, just hopes, as I see it and the same for ABSSSI. Just hopes. I really hope my perspective is much too negative and unfair to IPIX. I really hope that.
I reached this deeper phase of pessimism this morning as I opened my computer and read of another immunologic going to an FDA Ph3 for ulcerative colitis. I wish them well. See below:
January 6, 2022
Maintenance of Clinical Remission Observed With Mirikizumab in Ulcerative Colitis Trial
Brian Park, PharmD
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ulcerative colitis
Mirikizumab is an investigational anti-IL-23p19 monoclonal antibody. Credit: Shutterstock.
Positive results were announced from a phase 3 study evaluating mirikizumab, an investigational anti-IL-23p19 monoclonal antibody, as maintenance therapy in patients with moderately to severely active ulcerative colitis (UC).
The multicenter, randomized, double-blind, placebo-controlled maintenance study LUCENT-2 (ClinicalTrials.gov Identifier: NCT03524092) evaluated the efficacy and safety of mirikizumab in UC patients who achieved clinical response in the 12-week LUCENT-1 induction study (ClinicalTrials.gov Identifier: NCT03518086). Patients were randomly assigned to mirikizumab maintenance dosing or placebo for 40 weeks. The primary endpoint was clinical remission based on modified Mayo Score at week 40.
Results showed that a statistically higher proportion of patients treated with mirikizumab achieved clinical remission at 1 year compared with those who received placebo (P <.001). Mirikizumab also met all key secondary endpoints with a significantly higher proportions of patients achieving endoscopic remission, corticosteroid-free remission, resolution or near-resolution of bowel urgency, improvement in endoscopic histologic intestinal inflammation and maintenance of remission, and greater reduction from baseline in bowel urgency symptoms at 1 year, compared with placebo (all P <.001).
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The overall safety profile of mirikizumab was consistent with that seen in previous studies for UC. The most common adverse events reported were nasopharyngitis, arthralgia and exacerbation of UC.
“In this maintenance study, treatment with mirikizumab demonstrated clinically meaningful and statistically significant improvements in clinical, endoscopic and histologic measures, including reduction of bowel urgency – a novel endpoint in the LUCENT program,” said Bruce E. Sands, MD, MS, Dr. Burrill B. Crohn Professor of Medicine, Chief of the Dr Henry D. Janowitz Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai. “Bowel urgency is one of the most bothersome and disruptive symptoms people living with ulcerative colitis experience, and the LUCENT program leveraged an innovative and systematic patient-centric approach to assess patients’ symptoms.”
Mirikizumab is also being evaluated in the LUCENT-3 trial (ClinicalTrials.gov Identifier: NCT03519945), an open-label extension study for eligible patients who have participated in the mirikizumab UC clinical development program.
The Company intends to submit a Biologics License Application to the Food and Drug Administration (FDA) for the UC indication in the first half of 2022. Phase 3 trials investigating mirikizumab as a treatment for Crohn disease are ongoing.
Reference
Mirikizumab demonstrates superiority over placebo in phase 3 maintenance study in ulcerative colitis, supporting regulatory submissions in 2022. News release. Eli Lilly and Company. Accessed December 15, 2021. https://www.prnewswire.com/news-releases/mirikizumab-demonstrates-superiority-over-placebo-in-phase-3-maintenance-study-in-ulcerative-colitis-supporting-regulatory-submissions-in-2022-301444707.html.
This article originally appeared on MPR
Gawd I hope you are right. It just seems like we here are usually waiting the next "big thing".
"No one knows nuttin around here for sure"
For sure.
"There may be other things on the horizon but it's time to move past Covid. That ship, like others Admiral Ehrlich has sailed, was sunk."
Well said, zandant.
"And no, I never asked about IPIX"
I was referring to distant N. Italian relatives, who I did not ask about IPIX, not to Alfasigma.
Anyway, have a nice New Year. Healthy and happy.
FWIW, here is a 2020 posting/mention of a call I had with someone at US Alfasigma. Not quite as I recalled just a few hours ago, but pretty close, in essence.
Monday, 12/14/20 02:27:11 PM
Re: None 0
Post #
336574
of 386663
Open Invitation (Suggestion?) to Longs re contacting Alfasigma
I've sent notes to the company which were not answered, even sent a note on Facebook recently, so I'll see what happens with this track. Today I called the USA number and got someone in PR, or at least that's what I asked for. I asked the normal questions and was told the study was in the beginning phases. I asked was this relatively late start due to covid and was told "yes, that appears to be the case." or words to that effect. I spent quite a bit of time on the various sites and found nothing past the blurb that was put out last year. If you look at the 16 sites on Clinicaltrials.gov you see clinical activity, but not including IPIX. But, even trying hard to avoid Confirmation Bias, some timelines could have a "positive" interpretation re ascribing potential effects due to covid. After reviewing it all, I may look up the pps, track it a bit, and may even buy some, the company seems dynamic and successful. Even better if it were working B.
I asked about the covid study. It was a really short conversation. She mentioned covid in N. Italy and click. Really, not very shocking and before the issue of insufficient Brilacidn, I am guessing. I know you are good at parsing things, just not much here to parse. I did not go out and buy or sell more after the conversation. "Wow" does not seem an appropriate categorization. It didn't to me at the time.