chet
Footballguy
Will you edit your post and change the error I made? There should be 8 SAEs in the drug group. Thx.
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***OFFICIAL CYDY/Leronlimab Thread*** (2 Viewers)
- Thread starter This_Guy
- Start date
Dan Lambskin
Footballguy
Maybe bring back the pigeon smiley but rename it :CYDY:
![[icon]](/data/avatars/m/5/5167.jpg?1660313464){kind=avatar}
[icon]
Insoxicated
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djmich
Footballguy
adonis
Footballguy
kevzilla
Footballguy
If you mean Querulous and Anxious, yes, I imagine there'll be quite a bit of it.
chet
Footballguy
⚡DEADHEAD⚡
Footballguy
Here comes the LL discussion...
Fair to say Dr. Drew is a notch or two higher than Dr. Been and Dr. Yo?
Fair to say Dr. Drew is a notch or two higher than Dr. Been and Dr. Yo?
djmich
Footballguy
Holy cow, didnt realize this is tomorrow. We have until tonight to vote, wasn't Chet going to provide some final thoughts?That's when the dilution vote happens and everyone loses 16% of their investment value, right?
Mr Hammer, I would appreciate your input here.
Below is a question and answer I provided last week. Could studies run drastically differently? I’m having trouble understanding how efficacy data can take days longer than safety. Isn’t all the data unblinded at once? How difficult is it to massage data in a validated database?
On 7/16/2020 at 4:35 PM, [icon] said:
Expected timeline:
Friday: Unblind
"Following Week": Results
Which probably means unblind next week and results in the first week or two of August with this squad
Total guess, but suspect hospitals signed off on data before unblinding, otherwise could introduce bias. But probably totally wrong. @Whyatt likely knows protocol.
Whyatt reply:
The process for collecting clinical data is highly regulated and follows specific procedures to ensure it’s accurate. All data is “quantified” (a number, yes/no, etc.) and double checked. Assuming data is paper based, it’s entered into a validated program twice and checked for a perfect match. Once all this blind data is verified, it is locked in the database, then unblinded.
Once unblinded, top line results pop out quickly. Depending on how the database is set up, a more nuanced view of the data can take a bit more effort.
Chaz McNulty
Footballguy
Hmmm. I wonder why it typically takes 4-6 weeks for the data to come out after unblinding.
Capella
Footballguy
Drew for sure has more followers or fans or weirdos, whatever. What are they saying?
Chaz McNulty
Footballguy
I've heard it mentioned several times, and that this is considered hyper speed to get it this quick.
I googled time frame after unblinding and the first thing that popped up was this:
The time necessary to finalize the data can be up to three months or more after study closure. Requests can be made to unblind participants, on a case-by-case basis immediately for emergencies or urgent situations.Aug 12, 2016
⚡DEADHEAD⚡
Footballguy
They just started. Dr. Yo talked about and downplayed today's press release.
Dr. Yo "I'm into LL because of BP."
Dr. Yo "I'm into LL because of BP."
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General Malaise
Footballguy
MONORAIIIIIIIIIIIIIIIILLLLLLLLLLLLLL!!!!!!!!!
cosjobs
Footballguy
⚡DEADHEAD⚡
Footballguy
Dr. Yo's analogies are terrible.
⚡DEADHEAD⚡
Footballguy
So Dr. Drew was kind of a nothing burger. Not sure they even mentioned Cytodyn by name.
caustic
Footballguy
So are you trying to figure out if LL had a significant impact on the overall number or SAEs, or the number of patients with SAEs?
Polish Hammer
made of glass
I'm at my pool club with the family right now so I'll give a somewhat brief answer to this. Essentially the last sentence of what you quoted from yourself is kind of the answer. They have a somewhat complicated primary endpoint and numerous secondary endpoints. Each of these is going to require its own analysis. Once you have statistical information in place, then there's the interpretation that also gets into play. I'm assuming they aren't just going to release a chart of data but rather they want to ensure that there is a proper explanation and narrative surrounding this. That could be a large assumption considering how they've been behaving with releasing of information in the past, but that would be my take on it. To be fair, my experience is also mainly with actual publications and journals like Circulation, NEJM, etc. there is also a question of if they want the data to be peer-reviewed before it is released. And also when they do release it do they want to provide some sort of editorial / commentary? Will it be a manuscript or just a press release? All of these variables could play into it being days or longer before we see the actual conclusions. Again, I'm not an expert here, just have experience dealing with these from a sales perspective.
djmich
Footballguy
chet
Footballguy
Zegras11
Footballguy
I’m not sure why everyone here has this notion that SAEs relate to efficacy. I ran clinical trials at a NCI Cancer Center (I left last year to work at big Pharma). SAEs are what they sound like, adverse events related to the DRUG therapy, not the disease. During a trial any adverse event a pt experiences is graded and attributed to the drug (or placebo) or not.
All today told us was that Len is safe
, nothing else.
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adonis
Footballguy
For arguments sake, the numbers seem to show that leronlimab is safer than a saline injection. Why would we not interpret that as evidence the drug is doing more than just causing no harm? Wouldn't water/saline be the default? How could you come in safer than that if it's not measuring other things?I’m not sure why everyone here has this notion that SAEs relate to efficacy. I ran clinical trials at a NCI Cancer Center. SAEs are what they sound like, adverse events related to the DRUG therapy, not the disease. During a trial any adverse event a pt experiences is graded and attributed to the drug (or placebo) or not.
All today told us was that Len is safe
fantasycurse42
Footballguy Jr.
This is me too. If I’m fine and laying around in my home, there won’t be SAEs, if I’m sick with Covid, there could be... if the placebo has substantially more, isn’t that evidence of efficacy?
That’s not what that portion of the trial determines. It simply collects the AEs a patient on each arm of the trial is experiencing. The statistics of a trial are dictated by responses, not AEs. We would simply interpret this as Len is numerical safer than placebo. Don’t get me wrong, less adverse effects is better and you may make a GIANT leap and say the Len group has less AEs bc of something related to the additional therapy the placebo group needed, but that’s a stretch.
chet
Footballguy
So why would the drug arm have a significantly lower occurrence of SAEs than the placebo arm? As a layman, it seems to me that the drug influenced that outcome and on today's paid interview, NP said that Dr. Lalezari said that having 64% fewer SAEs than placebo could be viewed as significant.I’m not sure why everyone here has this notion that SAEs relate to efficacy. I ran clinical trials at a NCI Cancer Center. SAEs are what they sound like, adverse events related to the DRUG therapy, not the disease. During a trial any adverse event a pt experiences is graded and attributed to the drug (or placebo) or not.
All today told us was that Len is safe
Here is a link to the NCI common toxicity criteria, I would imagine it’s similar to what they use in ID:
https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcv20_4-30-992.pdf
A patient on a trial experiences an AE, it is graded and determined to be drug related or not. That’s is it.
https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcv20_4-30-992.pdf
A patient on a trial experiences an AE, it is graded and determined to be drug related or not. That’s is it.
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Many factors (what other supportive care they received, etc). Again, less is always better, but an inference to efficacy is not a statistical objective of any study I’m aware of. 
the efficacy data is also good, just not basing it off of AE data!!
I-ROK
Footballguy
Not really. There could be many reasons for the difference, and we have no idea what the significance value is. It could be by chance that less people had SAE to LL than the placebo.
I-ROK
Footballguy
ChiefD
Footballguy
I may end up losing money on this deal but I can honestly say I’ve been thoroughly entertained.
By the Stock Thread, the way Cytodyn has pretty much done everything seemingly wrong in this thing - it’s a miracle this thing is even where it is. If I had gotten in early, I think I would be out by now completely. Way too many red flags at this point.
As it is, I have to sit tight since I came in late. Not gonna hang in too much longer.
By the Stock Thread, the way Cytodyn has pretty much done everything seemingly wrong in this thing - it’s a miracle this thing is even where it is. If I had gotten in early, I think I would be out by now completely. Way too many red flags at this point.
As it is, I have to sit tight since I came in late. Not gonna hang in too much longer.
All they are saying is it was no worse than a placebo for that group. Not every condition is going to be represented in that small population. Not to mention that we don't know what the SAEs were or their severity.
fantasycurse42
Footballguy Jr.
Is it possible NP is so incompetent he thought this was the best data to put out?
