Next imagine those have a cost basis of under a dollar/share.Now imagine you have a Million Shares
If you mean Querulous and Anxious, yes, I imagine there'll be quite a bit of it.Is there going to be Q & A at this stockholder meeting tomorrow?
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.:reluctant sehorn:
Let me know if that works for everyone.@This_Guy Could we please get a cytodyn reference in the title and maybe a description about it curing Covid?
Hmmm. I wonder why it typically takes 4-6 weeks for the data to come out after unblinding.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.
Where did that timeframe come from?Hmmm. I wonder why it typically takes 4-6 weeks for the data to come out after unblinding.
Drew for sure has more followers or fans or weirdos, whatever. What are they saying?Here comes the LL discussion...
Fair to say Dr. Drew is a notch or two higher than Dr. Been and Dr. Yo?
I've heard it mentioned several times, and that this is considered hyper speed to get it this quick.Where did that timeframe come from?
I was thinking more a T&FIf you mean Querulous and Anxious, yes, I imagine there'll be quite a bit of it.
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?Come on--there are some bright people here. Let's figure this out.
In the placebo group, you have 28 patients who produced a total of 11 SAEs.
In the drug arm, you have 56 patients who produced a total of 8 SAEs.
To be clear, you DON'T want SAEs. So what is the probability that the drug influenced a better outcome?
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.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.
BassNBrew would need to change his vote every day.Why no pole with the number of shares owned by each of us?
Trying to figure out if LL kept the number of SAEs down in the drug arm. ThxSo 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?
BassNBrew would need to change his vote everydayminute.
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.Trying to figure out if LL kept the number of SAEs down in the drug arm. Thx
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 , nothing else.
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?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?
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.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?
You don't have enough data. What were the SAEs?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?
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 , nothing else.
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.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.
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.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?
We don’t know that it was significantly betterSo again, wouldn't you expect the best case scenario for any "safe" drug to be equivalent to the placebo if that is water/saline? What would ever make that significantly better than placebo?
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.So again, wouldn't you expect the best case scenario for any "safe" drug to be equivalent to the placebo if that is water/saline? What would ever make that significantly better than placebo?