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Stock Thread (38 Viewers)
- Thread starter St. Louis Bob
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caustic
Footballguy
Here’s the story on GILD’s trials: https://www.statnews.com/2020/04/16/early-peek-at-data-on-gilead-coronavirus-drug-suggests-patients-are-responding-to-treatment/
A Chicago hospital treating severe Covid-19 patients with Gilead Sciences’ antiviral medicine remdesivir in a closely watched clinical trial is seeing rapid recoveries in fever and respiratory symptoms, with nearly all patients discharged in less than a week, STAT has learned.
Remdesivir was one of the first medicines identified as having the potential to impact SARS-CoV-2, the novel coronavirus that causes Covid-19, in lab tests. The entire world has been waiting for results from Gilead’s clinical trials, and positive results would likely lead to fast approvals by the Food and Drug Administration and other regulatory agencies. If safe and effective, it could become the first approved treatment against the disease.
The University of Chicago Medicine recruited 125 people with Covid-19 into Gilead’s two Phase 3 clinical trials. Of those people, 113 had severe disease. All the patients have been treated with daily infusions of remdesivir.
“The best news is that most of our patients have already been discharged, which is great. We’ve only had two patients perish,” said Kathleen Mullane, the University of Chicago infectious disease specialist overseeing the remdesivir studies for the hospital.
Her comments were made this week during a video discussion about the trial results with other University of Chicago faculty members. The discussion was recorded and STAT obtained a copy of the video.
The outcomes offer only a snapshot of remdesivir’s effectiveness. The same trials are being run concurrently at other institutions, and it’s impossible to determine the full study results with any certainty. Still, no other clinical data from the Gilead studies have been released to date, and excitement is high. Last month, President Trump touted the potential for remdesivir — as he has for many still-unproven treatments — and said it “seems to have a very good result.”
In a statement Thursday, Gilead said: “What we can say at this stage is that we look forward to data from ongoing studies becoming available.”
Gilead had said to expect results for its trial involving severe cases in April. Mullane said during her presentation that data for the first 400 patients in the study would be “locked” by Gilead Thursday, meaning that results could come any day.
Mullane, while encouraged by the University of Chicago data, made clear her own hesitancy about drawing too many conclusions.
“It’s always hard,” she said, because the severe trial doesn’t include a placebo group for comparison. “But certainly when we start [the] drug, we see fever curves falling,” she said. “Fever is now not a requirement for people to go on trial, we do see when patients do come in with high fevers, they do [reduce] quite quickly. We have seen people come off ventilators a day after starting therapy. So, in that realm, overall our patients have done very well.”
She added: “Most of our patients are severe and most of them are leaving at six days, so that tells us duration of therapy doesn’t have to be 10 days. We have very few that went out to 10 days, maybe three,” she said.
Reached by STAT, Mullane confirmed the authenticity of the footage but declined to comment further.
Asked about the data, Eric Topol, director of the Scripps Research Translational Institute, described them as “encouraging.”
“The severely hit patients are at such high-risk of fatality. So if it’s true that many of the 113 patients were in this category and were discharged, it’s another positive signal that the drug has efficacy,” he said, adding that it will be important to see more data from randomized controlled studies.
Gilead’s severe Covid-19 study includes 2,400 participants from 152 different clinical trial sites all over the world. Its moderate Covid-19 study includes 1,600 patients in 169 different centers, also all over the world.
The trial is investigating five- and 10-day treatment courses of remdesivir. The primary goal is a statistical comparison of patient improvement between the two treatment arms. Improvement is measured using a seven-point numerical scale that encompasses death (at worst) and discharge from hospital (best outcome), with various degrees of supplemental oxygen and intubation in between.
The lack of a control arm in the study could make interpreting the results more challenging.
A lack of data has led to yo-yoing expectations for the drug. Two studies in China had enrollment suspended partway through because there were not enough patients available. A recent report of patients given the drug under a special program to make it available to those who are very ill generated both excitement and skepticism.
In scientific terms, all the data are anecdotal until the full trial reads out, meaning that they should not be used to draw final conclusions. But some of the anecdotes are dramatic.
Slawomir Michalak, a 57-year-old factory worker from a suburb west of Chicago, was among the participants in the Chicago study. One of his daughters started feeling ill in late March and was later diagnosed with mild Covid-19. Michalak, by contrast, came down with a high fever and reported shortness of breath and severe pain in his back.
“It felt like someone was punching me in the lungs,” he told STAT.
At his wife’s urging, Michalak went to the University of Chicago Medicine hospital on Friday, April 3. His fever had spiked to 104 and he was struggling to breath. At the hospital, he was given supplemental oxygen. He also agreed to participate in Gilead’s severe Covid-19 clinical trial.
His first infusion of remdesivir was on Saturday, April 4. “My fever dropped almost immediately and I started to feel better,” he said.
By his second dose on Sunday, Michalak said he was being weaned off oxygen. He received two more daily infusions of remdesivir and recovered enough to be discharged from the hospital on Tuesday, April 7.
“Remdesivir was a miracle,” he said.
The world is waiting to find out if it is really so.
Remdesivir was one of the first medicines identified as having the potential to impact SARS-CoV-2, the novel coronavirus that causes Covid-19, in lab tests. The entire world has been waiting for results from Gilead’s clinical trials, and positive results would likely lead to fast approvals by the Food and Drug Administration and other regulatory agencies. If safe and effective, it could become the first approved treatment against the disease.
The University of Chicago Medicine recruited 125 people with Covid-19 into Gilead’s two Phase 3 clinical trials. Of those people, 113 had severe disease. All the patients have been treated with daily infusions of remdesivir.
“The best news is that most of our patients have already been discharged, which is great. We’ve only had two patients perish,” said Kathleen Mullane, the University of Chicago infectious disease specialist overseeing the remdesivir studies for the hospital.
Her comments were made this week during a video discussion about the trial results with other University of Chicago faculty members. The discussion was recorded and STAT obtained a copy of the video.
The outcomes offer only a snapshot of remdesivir’s effectiveness. The same trials are being run concurrently at other institutions, and it’s impossible to determine the full study results with any certainty. Still, no other clinical data from the Gilead studies have been released to date, and excitement is high. Last month, President Trump touted the potential for remdesivir — as he has for many still-unproven treatments — and said it “seems to have a very good result.”
In a statement Thursday, Gilead said: “What we can say at this stage is that we look forward to data from ongoing studies becoming available.”
Gilead had said to expect results for its trial involving severe cases in April. Mullane said during her presentation that data for the first 400 patients in the study would be “locked” by Gilead Thursday, meaning that results could come any day.
Mullane, while encouraged by the University of Chicago data, made clear her own hesitancy about drawing too many conclusions.
“It’s always hard,” she said, because the severe trial doesn’t include a placebo group for comparison. “But certainly when we start [the] drug, we see fever curves falling,” she said. “Fever is now not a requirement for people to go on trial, we do see when patients do come in with high fevers, they do [reduce] quite quickly. We have seen people come off ventilators a day after starting therapy. So, in that realm, overall our patients have done very well.”
She added: “Most of our patients are severe and most of them are leaving at six days, so that tells us duration of therapy doesn’t have to be 10 days. We have very few that went out to 10 days, maybe three,” she said.
Reached by STAT, Mullane confirmed the authenticity of the footage but declined to comment further.
Asked about the data, Eric Topol, director of the Scripps Research Translational Institute, described them as “encouraging.”
“The severely hit patients are at such high-risk of fatality. So if it’s true that many of the 113 patients were in this category and were discharged, it’s another positive signal that the drug has efficacy,” he said, adding that it will be important to see more data from randomized controlled studies.
Gilead’s severe Covid-19 study includes 2,400 participants from 152 different clinical trial sites all over the world. Its moderate Covid-19 study includes 1,600 patients in 169 different centers, also all over the world.
The trial is investigating five- and 10-day treatment courses of remdesivir. The primary goal is a statistical comparison of patient improvement between the two treatment arms. Improvement is measured using a seven-point numerical scale that encompasses death (at worst) and discharge from hospital (best outcome), with various degrees of supplemental oxygen and intubation in between.
The lack of a control arm in the study could make interpreting the results more challenging.
A lack of data has led to yo-yoing expectations for the drug. Two studies in China had enrollment suspended partway through because there were not enough patients available. A recent report of patients given the drug under a special program to make it available to those who are very ill generated both excitement and skepticism.
In scientific terms, all the data are anecdotal until the full trial reads out, meaning that they should not be used to draw final conclusions. But some of the anecdotes are dramatic.
Slawomir Michalak, a 57-year-old factory worker from a suburb west of Chicago, was among the participants in the Chicago study. One of his daughters started feeling ill in late March and was later diagnosed with mild Covid-19. Michalak, by contrast, came down with a high fever and reported shortness of breath and severe pain in his back.
“It felt like someone was punching me in the lungs,” he told STAT.
At his wife’s urging, Michalak went to the University of Chicago Medicine hospital on Friday, April 3. His fever had spiked to 104 and he was struggling to breath. At the hospital, he was given supplemental oxygen. He also agreed to participate in Gilead’s severe Covid-19 clinical trial.
His first infusion of remdesivir was on Saturday, April 4. “My fever dropped almost immediately and I started to feel better,” he said.
By his second dose on Sunday, Michalak said he was being weaned off oxygen. He received two more daily infusions of remdesivir and recovered enough to be discharged from the hospital on Tuesday, April 7.
“Remdesivir was a miracle,” he said.
The world is waiting to find out if it is really so.
cosjobs
Footballguy
Sounds stupid to me. Maybe if they run at 20% capacity. And how are the customers getting there? Driving not an option for most.
sporthenry
Footballguy
Buy the rumor, sell the news. RRR, the locals casino could benefit since everyone will have stimulus checks to blow until that runs out.
cosjobs
Footballguy
sporthenry
Footballguy
No sorry for the confusion meant, Red Rock Resorts seems poised to benefit more than MGM. Granted it's up 17% in after hours.
cosjobs
Footballguy
Yeah, it for now, most dgaf about cancer and HIV, but they do have that in their back pocket for long term. I would not be surprised if I sell off in the morning and try to get back in when it goes back to a dollar stock. Sorry Chet.
cosjobs
Footballguy
Now that's one I'd like to take a look at, if it takes another dip down. What's the symbol?
cosjobs
Footballguy
sporthenry
Footballguy
RRR
I've liked it before all this. They also don't do any of the sale leaseback stuff. They bought the Palm and are renovating it after renovating Palace so leverage is up a bit due to that. I've just been reluctant to buy it since the LV economy is dependent on the Strip so if LV is in a recession, going to flow through to the locals.
I think there absolutely is room for multiple treatments. I have doubts CYDY will be in second place though.
cosjobs
Footballguy
Jefferson the Caregiver
Rebel Without A Pause
cosjobs
Footballguy
cosjobs
Footballguy
FreeBaGeL
Footballguy
Stay at home stocks are down after hours (Netflix, Roku, Amazon).
Pain stocks are up (banks, airlines, retail).
Interesting how the AH traders are reading the Gilead announcement as if everyone is going back out into the world now. I am interested to see how people react in the morning. If we shoot up more from here or if the realization hits that we are still probably a ways from that and it pulls back.
Pain stocks are up (banks, airlines, retail).
Interesting how the AH traders are reading the Gilead announcement as if everyone is going back out into the world now. I am interested to see how people react in the morning. If we shoot up more from here or if the realization hits that we are still probably a ways from that and it pulls back.
sporthenry
Footballguy
Well that is fair but I don't think casinos are also as much of a vice stock as some in here believe. If you actually look at '08/'09, gaming revenues declined pretty significantly in locations that weren't opening up casinos. Downtown/locals gaming revenue was down 10% in '08, 5% in '09 and '10. Yes, not 0 as a pandemic but not a V-shaped either. Guess 50% of YTD highs may still be attractive. Unless the government continues sending everyone stimulus checks, then casino stocks will be $.
The Ref
Footballguy
chet
Footballguy
Please understand I am not rooting against a viable treatment but this hope is really misplaced with Remdesivir. It has nasty side effects and people with knowledge have serious doubts about their trial.
Gilead even released a statement downplaying the importance of the results.
CYDY drug doesn't have adverse side effects.
matuski
Footballguy
You personally are doing a great job of representing yourself and your company here.
Not a fan of the paid article stuff, but I understand.
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JerseyToughGuys
Tough Guy
anyone playing the $?
"Dollar Milkshake" Theory?
interesting stuff
"Dollar Milkshake" Theory?
interesting stuff
beef
Footballguy
JerseyToughGuys
Tough Guy
it's complicated but essentially the demand for dollars makes it go supernova wrecking other currencies.
-OZ-
Footballguy
If this were perpetual I do think you'd find more early retirees. Or people doing what that want instead of what makes a living wage.
Kicking myself lightly for not dumping everything else and going all in for my Roth. Thought about it. But I don't do that with individual companies.
![[icon]](/data/avatars/m/5/5167.jpg?1660313464){kind=avatar}
[icon]
Insoxicated
-OZ-
Footballguy
cosjobs
Footballguy
Capella
Footballguy
-OZ-
Footballguy
They have all three of my credit cards and handle all the Lowes company accounts.
McBokonon
Footballguy
They have the PayPal 2% cash back Mastercard. If I wasn't mostly in the AMEX MR universe this would probably be my main card.
Don't follow me. I'm bargain hunting for quick gains. Go find Todem's master list from a week ago and take positions in those companies.
BigJohn
Footballguy
The Ref
Footballguy
Everything going to be limit up tomorrow morning: shorts are going to get faces ripped off. Im holding trades long BLMN mgm dal and even took a gamble on SPXL.
futures hit that 2880 level Mancini has been talking about and has gone sideways since. He did say this was the level to take profits and open up shorts (he clarified earlier the chart would like to see 2930).
FreeBaGeL
Footballguy
This remdisivir stuff seems pretty dubious to me. Apparently the guy that leaked the initial article has a history of trying to manipulate the market via well timed misleading article drops. The other article notes some extremely severe and horrifically common side effects.
I am tempted to throw down some puts on Gilead and/or the stocks that are rallying off of this news (or buy shares of the stuff that is falling based on it), but the market is acting so irrational right now I'm not sure if there will even be much of a pullback once they find out.
Now Gilead themselves are issuing press releases to try and stem the hype. I know people love to comment on Facebook after skimming an article headline without reading the actual article, but are people really about to pour trillions into the stock market because they didn't click the link and read all the way to the bottom to the part where it basically says half of the people receiving the drug get organ damage?
I am tempted to throw down some puts on Gilead and/or the stocks that are rallying off of this news (or buy shares of the stuff that is falling based on it), but the market is acting so irrational right now I'm not sure if there will even be much of a pullback once they find out.
Jefferson the Caregiver
Rebel Without A Pause
Just running with the knowledge of how CYDY puts out good news on a test and then the stock pulls back shortly after, probably can expect the same thing for GILD here. If Chet is right and there are problems with this test, it will pull back on that kind of news but the public will already have bought in first thing in the morning.
Could be a good play against, ive seen this movie before.
Could be a good play against, ive seen this movie before.
Jefferson the Caregiver
Rebel Without A Pause
Buy them shortly after market opens, good chance you can cash this. Unless of course they come right back with some real news, then you could be screwed.
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Jefferson the Caregiver
Rebel Without A Pause
How long after market opens will GILD peak before it starts to sell off?
The Ref
Footballguy
FreeBaGeL
Footballguy
Also worth noting that none of the people in the study that just blew up the market were on a ventilator.
So "only" 2 of 125 patients in the study so far have died. Which is probably about the normal death rate of coronavirus if we're not talking about people on a ventilator.
So "only" 2 of 125 patients in the study so far have died. Which is probably about the normal death rate of coronavirus if we're not talking about people on a ventilator.
