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***OFFICIAL CYDY/Leronlimab Thread*** (2 Viewers)

Capella said:
https://www.nytimes.com/2021/03/29/world/pfizer-moderna-covid-vaccines-infection.html
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I don't think you can take it as gospel but I hope you're right.  However, people who should know and that I trust have told me to think of it like the flu--varients will require a new shot every year and some years will be better than others.

There also has been concern that variants may render the vaccines less effective. The study’s results do not confirm that fear. Troubling variants were circulating during the time of the study — from Dec. 14, 2020, to March 13, 2021 — yet the vaccines still provided powerful protection.
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chet said:
Lead story at drudge.
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That story is highly slanted towards countries that aren’t doing as well with vaccines/poorer countries. The respondents definitely would fall under organizations that I think would stress the bad potential to try and get vaccines available. I agree with them on the availability, but I think that it’s not a purely scientific article.

 
Capella said:
That’s not news. Scientists have said the vaccines are incredibly easy to modify. 
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That's not the point--the point is that everyone will be needing yearly shots to protect against the latest variants.  This combined with anti-vaxxers etc, therapeutics will almost certainly play a significant role going forward.  

 
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chet said:
That's not the point--the point is that everyone will be needing yearly shots to protect against the latest variants.  With anti-vaxxers etc, therapeutics will almost certainly play a significant role going forward.  
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Oh I don’t disagree there is a need for therapeutics - I just think they missed their window for a big shot but that’s water under the bridge now. 

 
chet said:
That's not the point--the point is that everyone will be needing yearly shots to protect against the latest variants.  With anti-vaxxers etc, therapeutics will almost certainly play a significant role going forward.  
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Even if you are right, what evidence is there that CYDY management team can get the drug approved and used as one of the needed therapeutics?  

 
Steeler said:
Even if you are right, what evidence is there that CYDY management team can get the drug approved and used as one of the needed therapeutics?  
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Showing that it works in the critical cohort is a big step forward.  I know the drug works but current management is incompetent.  Changing them would be very helpful.

 
Our favorite Investorhub poster posted this last night...  2.47 and also posted 4/21 three different times.   The guy isn’t always right obvious but he is right a lot.   🤷‍♂️

 
chet said:
People coming to the realization that the drug works at day 14 and the company ####ed up dosing at later dates is very significant. 
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I think the company is going to take the bullet for the FDA on that and in turn something good will come from the FDA. 

 
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Dave RL said:
I think the company is going to take the bullet for the FDA on that and in turn something good will come from the FDA. 
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Getting Nader to take the blame for anything would be huge.  The guy is a narcissistic egomaniac.  

Back in March 2020, Dr. Patterson was presenting his COVID MOA hypothesis to shareholders, and someone said, "If your idea turns out to be correct, you deserve the Nobel Prize in medicine."  Nader stood up and said, "What about me?"

 
chet said:
Getting Nader to take the blame for anything would be huge.  The guy is a narcissistic egomaniac.  

Back in March 2020, Dr. Patterson was presenting his COVID MOA hypothesis to shareholders, and someone said, "If your idea turns out to be correct, you deserve the Nobel Prize in medicine."  Nader stood up and said, "What about me?"
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I hope this is a joke. 

 
chet said:
Getting Nader to take the blame for anything would be huge.  The guy is a narcissistic egomaniac.  

Back in March 2020, Dr. Patterson was presenting his COVID MOA hypothesis to shareholders, and someone said, "If your idea turns out to be correct, you deserve the Nobel Prize in medicine."  Nader stood up and said, "What about me?"
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I can't wait until you can tell more stories like this  :popcorn:

 
Closed at high of the day.  Impressive.

I have to think the FDA must issue an EUA based on the data in today's PR.  

 
Capella said:
Let’s hope. They *still* have to formally apply yes? 
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They've already applied assuming you believe Nader.  I think people estimated the application was submitted around March 10.  That leaves this week or next as the most likely times to receive a response.

 
chet said:
They've already applied assuming you believe Nader.  I think people estimated the application was submitted around March 10.  That leaves this week or next as the most likely times to receive a response.
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Ahh I thought I read on yahoo board that they had not. That would be a positive then. 

 
chet said:
They've already applied assuming you believe Nader.  I think people estimated the application was submitted around March 10.  That leaves this week or next as the most likely times to receive a response.
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Would they have submitted back then using the data found in the PR today?  Seems odd that they would have held onto that for so long.  If not, then will the FDA look at this new data when considering the EUA application regardless of whether or not it was in the original submittal?

 
unckeyherb said:
Would they have submitted back then using the data found in the PR today?  Seems odd that they would have held onto that for so long.  If not, then will the FDA look at this new data when considering the EUA application regardless of whether or not it was in the original submittal?
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I believe they just discovered the significance of this data.  I think the PR said they would file an addendum to inform the FDA and other regulatory agencies.

 
unckeyherb said:
Would they have submitted back then using the data found in the PR today?  Seems odd that they would have held onto that for so long.  If not, then will the FDA look at this new data when considering the EUA application regardless of whether or not it was in the original submittal?
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If the FDA is basing EUA based on single digit data groups when other single digit data groups in the study show the treated group has a worse outcome then I don't know why they exist.

 
NP says...LL patients over the age of 65 were in the hospital on average 5 days less than placebo patients.

The reality is...LL patients over the age of 65 died sooner and therefore weren't in the hospital as long.

 
Chet, you are acting like EUA on this small sub group is an automatic.  I'm no expert but they missed their primary endpoint and are an untrusted company on top of that.

I feel like the FDA has more controls in place than to issue an EUA on mined data to a tiny subgroup.  They would get skewered for this.

Still feels like a longshot to me

 
I think an EUA is also a longshot at this point.  I still believe it works for Critical, but I think they really messed up the trial.  I was shocked with the few number of criticals they had compared to severe.  I would have thought people on deaths door are more likely to try an experimental drug.

My concern is that it took them a long time to get just 62 critical patients.  How long will it take them to enroll 140 for the next trial? 

 
Dwayne Hoover said:
Chet, you are acting like EUA on this small sub group is an automatic.  I'm no expert but they missed their primary endpoint and are an untrusted company on top of that.

I feel like the FDA has more controls in place than to issue an EUA on mined data to a tiny subgroup.  They would get skewered for this.

Still feels like a longshot to me
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I just got out of a meeting with guys who are much more in the know than me and some agreed with you about the sample size.  My point is that statistically significant is just that regardless of whether you have 60 patients or 6000.  I think the difference in mortality between drug and placebo was so great that the FDA can't ignore it especially with nothing else working for criticals.  The FDA can give a restricted EUA and monitor is closely to ensure the new patients are getting better and if they aren't, they can pull the EUA.  The drug is safe so they don't have to worry about harming anyone.  Just my $0.02.

 
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