Is it positive that there were less SAEs in the Leronlimab arm - yes.
But I read into the results presented and wonder why they’re presented as they are. I shared my thoughts. So what’s next, try for phase 3? The ball is in CYDY’s court.
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But I read into the results presented and wonder why they’re presented as they are. I shared my thoughts. So what’s next, try for phase 3? The ball is in CYDY’s court.
No, data presented is safety only.
The death would be covered in the efficacy results.
djmich
Footballguy
I'm not sure what you mean presented as they are...what other way would you have presented them?
I'm not trying to be a ####, just not sure what else they could have done.
I think everyone agrees that the data is not complete, want to see detailed efficacy results. Based on usual timelines for this to be completed is it not unreasonable to expect those results over a weekend?
Are you saying that they should have released nothing at this point?
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https://finance.yahoo.com/quote/BBQ/
So how does a NASDAQ company only trade 1315 shares? 200 of those were mine.
So how does a NASDAQ company only trade 1315 shares? 200 of those were mine.
adonis
Footballguy
If the death had been in the placebo group I'm sure the press release would be different.
cosjobs
Footballguy
CytoDyn’s (OTCMKTS: CYDY) Strong Safety Data in Mild to Moderate Smokes Gilead (NASDAQ: GILD) & Crushes Endpoint Leading to the First Potential COVID-19 Approval
ByChris Sandburg
Posted on July 21, 2020
CytoDyn Inc. (OTCMKTS: CYDY) announced groundbreaking safety results from its phase 2 Mild to Moderate COVID-19 trial today. The company reported a statistically significant reduction in Severe Adverse Events (SAEs) over placebo. In Gilead Sciences (NASDAQ: GILD) SIMPLE Trial, remdesivir had Adverse Events as high as 55% versus 45% in the Standard of Care (SOC). In April, this paltry trial data earned remdesivir an emergency use authorization. In comparison to leronlimab, remdesivir had significantly worse safety data and only a 4 day reduction in the time to recovery. In the active arm, leronlimab only had 14% SAEs versus 39% SAEs in the placebo group. Dissecting the data even more there is an even more powerful finding. The press release stated “none of the SAEs in leronlimab arm were deemed related to study drug administration by the investigators.”
One of the biggest hurdles of regulatory approval is the safety section. These results earn leronlimab exceptionally high marks with respect to safety, but should come as no surprise because over 750 HIV patients have taken the drug without any safety issues. In the coming days or weeks the company plans on following up with the efficacy part of the trial and reveals whether or not it met its primary endpoint of clinical improvement assessed on a 12 point scale. The reason for optimism that leronlimab will crush its primary endpoint lies in the huge statistical reduction in SAEs. Scott Kelly, M.D., CytoDyn’s Chief Medical Officer, commented,
“We believe the significant reduction in SAEs in the leronlimab group ultimately translates into improved patient clinical outcomes. Prior drugs in clinical trials for the treatment of COVID-19 have resulted in an increase in SAEs in the drug treated arm versus placebo. We are extremely proud of these results.”
In a disease plagued with complications a severe reduction in the number of those complications is anecdotal evidence that the drug works. To quote Dr. Bruce Patterson of IncellDX, “anecdotes don’t come off of life support.”
REMDESIVIR VS LERONLIMAB
Leronlimab’s safety data shows a statistically significant reduction in SAEs of 32% between the active and placebo arm. In most clinical trials a reduction of 30% or more represents an approvable endpoint. Drilling down on the data we uncover that none of the SAEs were due to leronlimab, and that there was practically speaking a 100% reduction in SAEs. Remdesivir’s SIMPLE trial didn’t have a control arm, but it’s worth noting that the standard of care had a lower number of SAE’s than the active arm with remdesivir. What accounts for this anomaly is that remdesivir has 23% SAE’s (e.g. multiple organ dysfunction syndrome, septic shock, acute kidney injury, hypotension) in the patients that take it. Remdesivir is not a drug you want to give prophylactically. In layman’s terms the remdesivir cure could be worse than the disease, albeit not by much.
APPROVABLE DRUG
Fauci called remdesivir “the standard of care” and if we hold Fauci to his word then a 32% reduction in the SAEs is an approvable drug. With respect to efficacy leronlimab must beat a median recovery time of 11 days. Anecdotal results from the UCLA study on critical patients showed that the average time of hospitalization was 5 days. The anecdotal data using a patient population more severe shows that leronlimab could really make a dent in the length of hospital stays. In fact, leronlimab could turn the tide in this war against COVID-19. If the FDA sees fit to approve a very safe drug on the verge of HIV approval then the world will have a drug that arrests the disease progression, prevents people from dying, gets people out of the hospital, and could eventually turn this economy around.
The next readout is in the CD12 trial for severe COVID-19 patients. CytoDyn has requested the Drug Safety Monitoring Committee to review the progress. If these mild to moderate results translate to the severe group there is a very real chance that they will pull a “Fauci” and deem it unethical to continue with the placebo arm. In the severe group mortality is being measured, and if the placebo group closely resembles the SOC there will be deaths. The number of deaths in the control arm will be compared to the number of deaths in the active drug arm.
It seems abundantly clear there is a statistically significant reduction in SAEs in the mild to moderate group. Assuming there is also a significant reduction in SAEs in the severe group there will be a corresponding reduction of death in the active arm. It’s important to highlight that SAEs in the severe group are more likely to translate into death so lowering the number of SAEs is tantamount to lowering the death rate. Based on this logic investors should be prepared for an FDA decision on approval, Breakthrough Therapy Designation (BTD), or a Special Protocol Assessment (SPA) leading to approval.
INVESTMENT SUMMARY
It’s very clear from these trial results that leronlimab is on the pathway to expedited FDA approval. Within weeks it’s possible if not probable that leronlimab will be the first drug approved in COVID-19. The worldwide pandemic has necessitated the development of a treatment for COVID-19 while the race for vaccine candidates continues as Moderna (NASDAQ: MRNA), Pfizer (NYSE: PFE), and AstraZeneca (NYSE: AZN) jockey for position. Leronlimab has the ability to get people out of the hospital. It is a simple subcutaneous shot that is very easily administered. Overall it’s a game changer in the war against COVID-19, and is a much more viable treatment than remdesivir. After the STAT News report, $10 billion of market cap flowed into GILD on news that they had a viable therapeutic. Using this same benchmark for valuation it is anticipated that CYDY will gravitate to the $25 price target as the market anticipates approval. CYDY is not a one trick pony and has a platform technology that would likely expand indications in HIV, cancer, NASH, Multiple Sclerosis, Alzheimer’s, and other immunological diseases. Many of these indications overlap GILD’s current pipeline, perplexing many CYDY shareholders who thought GILD was going to purchase CYDY. It seems clear that CYDY has intentions to develop its own pipeline, forge licensing deals, pursue a NASDAQ listing in the coming weeks, and compete head to head against GILD starting with remdesivir.
From Insider Financial, whoever tf that is.
ByChris Sandburg
Posted on July 21, 2020
CytoDyn Inc. (OTCMKTS: CYDY) announced groundbreaking safety results from its phase 2 Mild to Moderate COVID-19 trial today. The company reported a statistically significant reduction in Severe Adverse Events (SAEs) over placebo. In Gilead Sciences (NASDAQ: GILD) SIMPLE Trial, remdesivir had Adverse Events as high as 55% versus 45% in the Standard of Care (SOC). In April, this paltry trial data earned remdesivir an emergency use authorization. In comparison to leronlimab, remdesivir had significantly worse safety data and only a 4 day reduction in the time to recovery. In the active arm, leronlimab only had 14% SAEs versus 39% SAEs in the placebo group. Dissecting the data even more there is an even more powerful finding. The press release stated “none of the SAEs in leronlimab arm were deemed related to study drug administration by the investigators.”
One of the biggest hurdles of regulatory approval is the safety section. These results earn leronlimab exceptionally high marks with respect to safety, but should come as no surprise because over 750 HIV patients have taken the drug without any safety issues. In the coming days or weeks the company plans on following up with the efficacy part of the trial and reveals whether or not it met its primary endpoint of clinical improvement assessed on a 12 point scale. The reason for optimism that leronlimab will crush its primary endpoint lies in the huge statistical reduction in SAEs. Scott Kelly, M.D., CytoDyn’s Chief Medical Officer, commented,
“We believe the significant reduction in SAEs in the leronlimab group ultimately translates into improved patient clinical outcomes. Prior drugs in clinical trials for the treatment of COVID-19 have resulted in an increase in SAEs in the drug treated arm versus placebo. We are extremely proud of these results.”
In a disease plagued with complications a severe reduction in the number of those complications is anecdotal evidence that the drug works. To quote Dr. Bruce Patterson of IncellDX, “anecdotes don’t come off of life support.”
REMDESIVIR VS LERONLIMAB
Leronlimab’s safety data shows a statistically significant reduction in SAEs of 32% between the active and placebo arm. In most clinical trials a reduction of 30% or more represents an approvable endpoint. Drilling down on the data we uncover that none of the SAEs were due to leronlimab, and that there was practically speaking a 100% reduction in SAEs. Remdesivir’s SIMPLE trial didn’t have a control arm, but it’s worth noting that the standard of care had a lower number of SAE’s than the active arm with remdesivir. What accounts for this anomaly is that remdesivir has 23% SAE’s (e.g. multiple organ dysfunction syndrome, septic shock, acute kidney injury, hypotension) in the patients that take it. Remdesivir is not a drug you want to give prophylactically. In layman’s terms the remdesivir cure could be worse than the disease, albeit not by much.
APPROVABLE DRUG
Fauci called remdesivir “the standard of care” and if we hold Fauci to his word then a 32% reduction in the SAEs is an approvable drug. With respect to efficacy leronlimab must beat a median recovery time of 11 days. Anecdotal results from the UCLA study on critical patients showed that the average time of hospitalization was 5 days. The anecdotal data using a patient population more severe shows that leronlimab could really make a dent in the length of hospital stays. In fact, leronlimab could turn the tide in this war against COVID-19. If the FDA sees fit to approve a very safe drug on the verge of HIV approval then the world will have a drug that arrests the disease progression, prevents people from dying, gets people out of the hospital, and could eventually turn this economy around.
The next readout is in the CD12 trial for severe COVID-19 patients. CytoDyn has requested the Drug Safety Monitoring Committee to review the progress. If these mild to moderate results translate to the severe group there is a very real chance that they will pull a “Fauci” and deem it unethical to continue with the placebo arm. In the severe group mortality is being measured, and if the placebo group closely resembles the SOC there will be deaths. The number of deaths in the control arm will be compared to the number of deaths in the active drug arm.
It seems abundantly clear there is a statistically significant reduction in SAEs in the mild to moderate group. Assuming there is also a significant reduction in SAEs in the severe group there will be a corresponding reduction of death in the active arm. It’s important to highlight that SAEs in the severe group are more likely to translate into death so lowering the number of SAEs is tantamount to lowering the death rate. Based on this logic investors should be prepared for an FDA decision on approval, Breakthrough Therapy Designation (BTD), or a Special Protocol Assessment (SPA) leading to approval.
INVESTMENT SUMMARY
It’s very clear from these trial results that leronlimab is on the pathway to expedited FDA approval. Within weeks it’s possible if not probable that leronlimab will be the first drug approved in COVID-19. The worldwide pandemic has necessitated the development of a treatment for COVID-19 while the race for vaccine candidates continues as Moderna (NASDAQ: MRNA), Pfizer (NYSE: PFE), and AstraZeneca (NYSE: AZN) jockey for position. Leronlimab has the ability to get people out of the hospital. It is a simple subcutaneous shot that is very easily administered. Overall it’s a game changer in the war against COVID-19, and is a much more viable treatment than remdesivir. After the STAT News report, $10 billion of market cap flowed into GILD on news that they had a viable therapeutic. Using this same benchmark for valuation it is anticipated that CYDY will gravitate to the $25 price target as the market anticipates approval. CYDY is not a one trick pony and has a platform technology that would likely expand indications in HIV, cancer, NASH, Multiple Sclerosis, Alzheimer’s, and other immunological diseases. Many of these indications overlap GILD’s current pipeline, perplexing many CYDY shareholders who thought GILD was going to purchase CYDY. It seems clear that CYDY has intentions to develop its own pipeline, forge licensing deals, pursue a NASDAQ listing in the coming weeks, and compete head to head against GILD starting with remdesivir.
From Insider Financial, whoever tf that is.
Last edited by a moderator:
fantasycurse42
Footballguy Jr.
I don’t think any realistic investor anticipated an EUA after a 75 patient trial.
i do believe once we see efficacy here and positive interim on the Critical group, in a perfect world it is possible, especially with a POTUS desperate for a win.
djmich
Footballguy
I can only interpret what they wrote, not what they would have written under imaginary circumstances
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Capella
Footballguy
The whole thing is fascinating to me. The stock, the results, what it may or may not mean for the pandemic and people’s reactions. There’s like 5 people here I really want to play poker with
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fantasycurse42
Footballguy Jr.
My bottom line is no chance I’m selling on this.
⚡DEADHEAD⚡
Footballguy
There was lots of pressure to release something today. This may have been the best they could do in a short time frame. It's topline after all.
If I'm a short, Trump's tweet coupled with the restart of the WH briefings would scare the crap out of me.
If I'm a short, Trump's tweet coupled with the restart of the WH briefings would scare the crap out of me.
JerseyToughGuys
Tough Guy
cosjobs
Footballguy
Balakrishna Bhat Divana
16m ·
Safety: None of the SAEs in the leronlimab arm were deemed related to study drug administration by the investigators. So, there is absolutely no safety issues.
Efficacy: Significantly less AE/ASEs in the treatment arm compared to placebo arm indicates that the drug is very efficacious. The real efficacy number is determined based on condition of patients on days 0, 3, 7, and 14. We will have to wait.
16m ·
Safety: None of the SAEs in the leronlimab arm were deemed related to study drug administration by the investigators. So, there is absolutely no safety issues.
Efficacy: Significantly less AE/ASEs in the treatment arm compared to placebo arm indicates that the drug is very efficacious. The real efficacy number is determined based on condition of patients on days 0, 3, 7, and 14. We will have to wait.
⚡DEADHEAD⚡
Footballguy
Remember this is our primary measure:
Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) [ Time Frame: Day 14 ]
Note: The total score per patient ranges from 0 to 12 points. Each symptom is graded from 0 to 3. [0=none, 1=mild, 2=moderate, and 3=severe]. Higher scores mean a worse outcome.
Primary outcome measure
In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) [ Time Frame: Day 14 ]
Note: The total score per patient ranges from 0 to 12 points. Each symptom is graded from 0 to 3. [0=none, 1=mild, 2=moderate, and 3=severe]. Higher scores mean a worse outcome.
Primary outcome measure
In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
cosjobs
Footballguy
I'd push back by claiming that a pull back is likely if/when CYDY sniffs $10. If you believe in the drug then just hold, of course. But if you believe that this thing is manipulable (and I do), then the $10 mark seems to be a fine place to sell a fraction with the intention of buying back when it pulls back into the 7s or 8s. See also: chet.
Capella
Footballguy
fantasycurse42
Footballguy Jr.
Capella
Footballguy
cosjobs
Footballguy
cosjobs
Footballguy
cosjobs
Footballguy
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You and I sold a bit yesterday to cover ourselves. I’m the same way and I’m letting it roll. Funny thing is I have about the same number of shares I had when it went to $10 so really only sold extras I bought after the bear raid. It was enough to make me comfortable going forward. If it does somehow get to $10+, I’ll probably sell another chunk to book a nice profit and see where it goes. If the results are great enough to get approval then it may blow by $10, who knows.
Take this link for a German exchange: https://www.boerse-stuttgart.de/de-de/produkte/aktien/stuttgart/a0yha5-cytodyn-inc------dl--01
Golf Guy 69
Footballguy
adonis
Footballguy
My expectations were results showing efficacy. I was and still am disappointed we didn’t get those but these results are indeed impressive the more one mulls them over.
No SAEs from leronlimab. More than 50% less SAE’s in trial vs placebo despite twice the patients. That is meaningful and strongly suggests good efficacy because otherwise how to explain the fewer events?
![[icon]](/data/avatars/m/5/5167.jpg?1660313464){kind=avatar}
caustic
Footballguy
I mean, it depends on how much lower. Back of hand calculations, since 21.4% of placebo patients had SAEs but only 8.9% of the drug patients did, that’s statistically significant at the 5% (but not 1%) level. If two more drug patients had SAEs (so 21.4% vs 12.5%), it’s no longer significant at 5%. So the difference between significance and insignificance is razor thin with such a small group.
ex-ghost
Footballguy
adonis
Footballguy
We were expecting red meat but instead got a pasta appetizer. After the disappointment wears off the quality of the dish becomes apparent.
its good news. Leaves me wanting my main course but it’s really good.
JerseyToughGuys
Tough Guy
Meanwhile, precious metals and related miners are melting up again.
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ghostguy123
Footballguy
Are any of you actually qualified to be able to tell us if the results are good?
cosjobs
Footballguy
Otis
Footballguy
cosjobs
Footballguy
Anyone know the best Uranium stock to invest? I'm loaded to the gills on Gold and SilverMeanwhile, precious metal and related miners are melting up again.
