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Mission146
Mission146
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August 29th, 2021 at 5:38:21 PM permalink
Quote: AuraAngel2tu

FDA has been fraught with corruption going way back and has only gotten worse with time passing. DSMC has had a few snafus as well. As someone said, it either works or it doesn't. Yes, I agree. Too bad the FDA doesn't work like that. /2021/06/11/1005567149/3-experts-have-resigned-from-an-fda-committee-over-alzheimers-drug-approval

What an awful crime when those in the leronlimab covid trial were denied dosing after second dose.... and then passed. The trial was a set up to fail and should have never been agreed to by the company. It was like watching a prize fight in Vegas with one of the contenders hand tied behind his back. A system that is compassion limited and that works in opposition to the Hippocratic Oath must be replaced. We have no other choice if we want to advance as a culture. That public scolding of CytoDyn by the FDA was highly unusual. Deviously and intentionally a political hit job written in a way to mislead the public. A passing trial and approval in Brazil will be a real smack down to the USA FDA. They deserve a knock out punch.



Since we’re talking about the stock and you’re new, may I ask if you currently have a position or intend to initiate one? As far as I know, you’re not legally required to answer that question if you do not wish to do so.
https://wizardofvegas.com/forum/off-topic/gripes/11182-pet-peeves/120/#post815219
darkoz
darkoz
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August 29th, 2021 at 5:59:56 PM permalink
Quote: Mission146

Since we’re talking about the stock and you’re new, may I ask if you currently have a position or intend to initiate one? As far as I know, you’re not legally required to answer that question if you do not wish to do so.



He probably does.

But he brought up something that I felt would get pooh-poohed on here so let me go into detail.

The FDA insisted on the trial having only two doses AND examination of results 28 days later.

The drug has a 7 day response and has been used this manner for HIV for years. That is HIv patients get one shot every week.

HIV ocf course is a lifetime disease. Covid-19 isn't so you wouldn't need a lifetime of weekly injections. Just four if you are going to evaluate it at 28 days.

The FDA insisted on two doses only.

Dose at day zero

Dose at day seven (patients examined showed 79% better than placebo)

Day fourteen (no third dose but seven days after last dose patients showed 84% better results than placebo)

Day twenty-one (two weeks since last dose patients showed 54% better than placebo)

Day twenty-eight (three weeks since last dose patients showed only 24% better than placebo which made them not qualify for their P-value (P-value is a measurement score for drug efficacy)

So basically the drug efficacy got worse the further out from being dosed.

This is equivalent to testing out a seven day antibiotic and insisting the trial only go for three days dosage, then complaining the drug failed to work.

The trial should have been allowed to go four doses. The new trials in Brazil that are starting are four doses proper.

I mean, what a novel idea, actually administering the drug properly to see if it works.

All of this get into conspiracy territory (hence my reluctance to bring it up) but it does seem FDA has been compromised when (as the new poster linked to) another drug that all independent agencies said doesn't work got FDA approval for this big pharmaceutical company leading to resignations.

The conspiracy theory is that big pharma companies don't want any drug that will endanger their cash cows, like a drug that beats cancer, covid and HIV. So they convince the FDA to slow walk or sabotage the trials.

BTW, FDA is financed by big pharma. Like, literally they get more than half their funding from big pharma companies. No conflicts of interest there, right?
For Whom the bus tolls; The bus tolls for thee
AuraAngel2tu
AuraAngel2tu
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August 29th, 2021 at 6:46:34 PM permalink
Of course the drug affect goes down in these severe cases after a week which is why the FDA insisted on that parameter knowing efficacy withers with time.
Had the FDA really cared, they would have allowed at least 4 doses, one each week. You take a poor fella about dead and give him just a little medicine and expect recovery. Amazing thing is some did recover at a higher rate than SOC and placebo. Yes, I am very aware of FDA with their hands out taking BP money. This should not be allowed. It is like lobbyist being able to pay congressmen for their votes. A couple of my friends sell pharma drugs for a living. They know how to bribe and schmooze the hospitals and doctors. Everyone likes perks. Vegas thrives off of it. Remember the junkets? Now those were the days!
gordonm888
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gordonm888
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Thanks for this post from:
Mission146Dieter
August 29th, 2021 at 11:44:30 PM permalink
Quote: Mission146

<snip>
I don't have a problem with Cytodyn in particular; I don't even know why I have been reading this thread. <snip>



I've read this entire thread and found this to be the funniest line so far. Carry on.
So many better men, a few of them friends, are dead. And a thousand thousand slimy things live on, and so do I.
billryan
billryan
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August 30th, 2021 at 9:16:20 AM permalink
Quote: darkoz

DRich linked to an article about Cytodyn receiving the patent on Leronlimab. He wasn't suggesting investing on the way down on a hope but on information that the company has hit a legal milestone.

If Leronlimab's molecule is synthesized by any other pharmaceutical company they will owe patent fees or whatever.

Leronlimab has shown extremely good results. It's missed it's end points by a very small margin which is why the FDA refused to okay it (even though a few competing drugs that failed the mark by worse got approved thanks to their big pharma connection but hey welcome to corruption).

Point is this close you don't say "Ok, we were close, next!". What you do is figure out what is needed to hit the mark. Different dosage, different schedule of application etc.

And now if some big pharma company tries to step in and develop their own version guess what, they get a letter of patent from Cytodyn.

So based on information, not "gee, otc sucks" DRich is asking isn't this a good time to buy.





Dark oz keeps insisting lemonlabob missed its end points by a small margin while the FDA says it was a total failure and produced results similar to the placebo.
Who should we believe?
The difference between fiction and reality is that fiction is supposed to make sense.
darkoz
darkoz
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August 30th, 2021 at 9:26:34 AM permalink
Quote: billryan

Dark oz keeps insisting lemonlabob missed its end points by a small margin while the FDA says it was a total failure and produced results similar to the placebo.
Who should we believe?



I don't know what lemonlabob is. Sorry if you invested in that.

As for Leronlimab the FDA said they are prepared to continue with trials.

Not exactly the words "Total failure" which you claim they said (nowhere in the FDA statement are the words Total failure used. That's Bill Ryans words. Who's words are you going to believe).

Here is the FDA final statement on the subject. Mentioning forward trials. Not exactly what one would expect of a "total failure".



So apparently Bill believes that when a drug is a "total failure" the FDA discusses and continues trials.

LMFAO.
For Whom the bus tolls; The bus tolls for thee
billryan
billryan
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August 30th, 2021 at 9:47:37 AM permalink
Dark oz quotes the last piece of the document but leaves out this:

With the conclusion of both the CD10 and CD12 clinical trials, it has become clear that the data currently available do not support the clinical benefit of leronlimab for the treatment of COVID-19.


In the smaller study that CytoDyn conducted in patients with mild-to-moderate COVID-19 disease (CD10), there was no observed effect of the drug on the study’s primary endpoint or on any of the secondary endpoints


The primary endpoint for the CD10 trial relied on a measure of participants’ COVID-19 symptoms called a “total clinical symptom score”, which was assigned based on the severity of each participant’s fever, muscle aches, shortness of breath, and cough. This score ranged from 0 (no symptoms) to 12 (all 4 symptoms present and severe). The CD10 trial results showed no clinically meaningful differences in average change in “total clinical symptom score” from baseline to Day 14 between study arms (-3.5 in the leronlimab group versus -3.4 in the placebo group). Additionally, none of the secondary endpoints were met in this study, including mortality, time to symptom resolution, and time to return to normal activity. Taken together, the CD10 results indicate that most study participants experienced resolution in COVID-19 symptoms regardless of whether they received leronlimab or placebo.



The larger trial that CytoDyn conducted in patients with severe COVID-19 disease (CD12) also failed to find any effect of the drug on the primary study endpoint, with no difference seen in mortality (20.5% in the leronlimab treatment group and 21.6% in the placebo treatment group); or on any of the secondary endpoints, for example, with no difference on the average length of hospitalization (21.4 days in both the leronlimab and the placebo treatment groups).

CytoDyn has publicly communicated differences in small subgroups from the CD12 trial (e.g., a sub-group analysis of 62 of the 394 patients studied) suggesting that the data demonstrated a mortality benefit in certain patients who had received leronlimab. Subgroup analyses have well-established limitations, especially in the context of a clinical trial that has failed to show a benefit in the overall study population. For example, subgroups are often small, and therefore imbalances are common. Here, the data from CD12 illustrated imbalances in mortality among subgroups, some favoring leronlimab and some favoring placebo. None of these analyses met statistical significance when using established and reliable analytical methods that correct for multiple comparisons. However, as noted above, such analyses may inform the design of future clinical trials investigating leronlimab for the treatment of COVID-19.


Failed to find any effect....
no difference on the average length.....
no observed effects.....


I have no idea why oz continues to post things that are verifiably untrue. I can't judge his motives but it is clear he refuses to recognize the reality of these trials.
I'll repeat. The FDA says the CD10 and CD12 trials did not support any benefit for the treatment of Covid 19. It's all there in the very document oz selectively edited to attempt to prove his point.
The difference between fiction and reality is that fiction is supposed to make sense.
darkoz
darkoz
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August 30th, 2021 at 10:02:09 AM permalink
Quote: billryan

Dark oz quotes the last piece of the document but leaves out this:

With the conclusion of both the CD10 and CD12 clinical trials, it has become clear that the data currently available do not support the clinical benefit of leronlimab for the treatment of COVID-19.


In the smaller study that CytoDyn conducted in patients with mild-to-moderate COVID-19 disease (CD10), there was no observed effect of the drug on the study’s primary endpoint or on any of the secondary endpoints


The primary endpoint for the CD10 trial relied on a measure of participants’ COVID-19 symptoms called a “total clinical symptom score”, which was assigned based on the severity of each participant’s fever, muscle aches, shortness of breath, and cough. This score ranged from 0 (no symptoms) to 12 (all 4 symptoms present and severe). The CD10 trial results showed no clinically meaningful differences in average change in “total clinical symptom score” from baseline to Day 14 between study arms (-3.5 in the leronlimab group versus -3.4 in the placebo group). Additionally, none of the secondary endpoints were met in this study, including mortality, time to symptom resolution, and time to return to normal activity. Taken together, the CD10 results indicate that most study participants experienced resolution in COVID-19 symptoms regardless of whether they received leronlimab or placebo.



The larger trial that CytoDyn conducted in patients with severe COVID-19 disease (CD12) also failed to find any effect of the drug on the primary study endpoint, with no difference seen in mortality (20.5% in the leronlimab treatment group and 21.6% in the placebo treatment group); or on any of the secondary endpoints, for example, with no difference on the average length of hospitalization (21.4 days in both the leronlimab and the placebo treatment groups).

CytoDyn has publicly communicated differences in small subgroups from the CD12 trial (e.g., a sub-group analysis of 62 of the 394 patients studied) suggesting that the data demonstrated a mortality benefit in certain patients who had received leronlimab. Subgroup analyses have well-established limitations, especially in the context of a clinical trial that has failed to show a benefit in the overall study population. For example, subgroups are often small, and therefore imbalances are common. Here, the data from CD12 illustrated imbalances in mortality among subgroups, some favoring leronlimab and some favoring placebo. None of these analyses met statistical significance when using established and reliable analytical methods that correct for multiple comparisons. However, as noted above, such analyses may inform the design of future clinical trials investigating leronlimab for the treatment of COVID-19.


Failed to find any effect....
no difference on the average length.....
no observed effects.....


I have no idea why oz continues to post things that are verifiably untrue. I can't judge his motives but it is clear he refuses to recognize the reality of these trials.
I'll repeat. The FDA says the CD10 and CD12 trials did not support any benefit for the treatment of Covid 19. It's all there in the very document oz selectively edited to attempt to prove his point.



Notice Bill left out pointing to his quote "total failure"

Because nowhere does it say that

Nowhere in this world does a drug have total failure and then the FDA says they are fine with moving forward on similar trials of the same drug.

Bill doesn't understand how things work even though he tries very hard.

I have no idea why Bill is so anxious to prove Leronlimab failure. He has nothing invested in this apparently except some form of bravado by saying"I told you so".

So he leaves out and discounts what doesn't suit his agenda.
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billryan
billryan
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August 30th, 2021 at 10:09:55 AM permalink
Failed to find any effect....
no difference on the average length.....
no observed effects.....


Perhaps dark oz looks at those phrases and reads " success".

I notice the FDA says "Failed to find any effect. " Perhaps they really meant It succeeded to not find any effect, or that they successfully showed no difference on the average length.
Thats the ticket. They didn't fail to find any observed effects between the drug and the placebos. They successfully proved lemonlabob was equally effective as the placebos.
The difference between fiction and reality is that fiction is supposed to make sense.
darkoz
darkoz
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August 30th, 2021 at 10:33:59 AM permalink
Quote: billryan

Failed to find any effect....
no difference on the average length.....
no observed effects.....


Perhaps dark oz looks at those phrases and reads " success".

I notice the FDA says "Failed to find any effect. " Perhaps they really meant It succeeded to not find any effect, or that they successfully showed no difference on the average length.
Thats the ticket. They didn't fail to find any observed effects between the drug and the placebos. They successfully proved lemonlabob was equally effective as the placebos.



I'm sorry you don't fully comprehend the documents from the FDA or lack understanding of clinical trials.

When the drug is a total failure trials do not move forward.

However when trials show they didn't have the intended effect but there appears from the science a way forward, then new trials are designed.

These trials will be designed to see if the dosage can be improved, time, outcomes, etc.

The FDA pretty much says as such when they conclude there is a path forward for future trials.

Quoting three words out of the document to make your case is sad. I understand you think that those three words prove your case but again the FDA conclusion (and after all the conclusion remarks are what is most important) is that Cytodyn can use the previous trials as exploratory for further trials.

That simply isn't the medical definition of total failure for a biotech drug.

You can keep quoting a few words here and there but the final conclusion by the FDA approving a way forward doesn't change.
For Whom the bus tolls; The bus tolls for thee

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