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13 minutes ago, mission27 said:

The article I posted was a little confusing but I think what they're saying is the Gilead study is not placebo controlled.  The NIH study was and Fauci and Gilead are now both saying results are very positive 

I hope I’m wrong but I have little faith in hastily conducted studies. Remdesivir will not prove to be a meaningful difference maker. 

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10 minutes ago, diehardlionfan said:

If you followed Canadas outbreak the Toronto cases were traced directly to travel to and from Iran. On the west coast over 20,000 people travelled from Wuhan to the greater Vancouver area before travel restrictions. In Canada’s case it’s all related to travel.

Its always all related to travel though.  The original case was in China, so cases are always originally imported in every other country.  Its not like we are seeing spontaneous new bat-to-human transmission in the US or Italy. 

My point is that if you look at when large scale explosive community spread starts and we get a true hot spots its generally in the 35-50 F range.

EDIT: the best example would be the outbreak in Quebec, the northeast US and Quebec cases started to see really aggressive community spread likely in late February that wasnt detected until mid-March. mission was almost certainly a disease vector btw as he traveled regularly from New York to both Ontario and Quebec in February.  Both northeast US and eastern Canada had a huge cold wave in early-mid February and then warmed up to the 30s and 40s in late February and saw a huge spike in cases a couple of weeks later.  Could be a coincidence, but it lines up with the seasonality we saw in Wuhan, Milan, and Moscow very cleanly

Edited by mission27
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1 minute ago, diehardlionfan said:

I hope I’m wrong but I have little faith in hastily conducted studies. Remdesivir will not prove to be a meaningful difference maker. 

This would follow past uses of the drug that showed it was not even as effective as monoclonal antibodies in fighting the virus. I will say it could very well be a short term difference maker while other treatments are being tested. 

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2 minutes ago, ramssuperbowl99 said:

Even if this just a short term solution to limit mortality, fine. The end goal here is still a vaccine. In the interim we really just need to do enough to keep people alive and get the economy restarted.

Right and it’s not just mortality (which is honestly already low enough for all but seniors to be tolerable imo), if we can reduce time to recovery and keep people off ventilators we stop the hospitals from being overwhelmed which is a bigger issue.  Giving someone remdesivir is a lot easier than putting them on a vent for 3 week.

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6 minutes ago, mission27 said:

Right and it’s not just mortality (which is honestly already low enough for all but seniors to be tolerable imo), if we can reduce time to recovery and keep people off ventilators we stop the hospitals from being overwhelmed which is a bigger issue.  Giving someone remdesivir is a lot easier than putting them on a vent for 3 week.

The downside here is that it's IV only, and per the FDA since forever, that can only be done in a hospital.

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19 minutes ago, ramssuperbowl99 said:

Even if this just a short term solution to limit mortality, fine. The end goal here is still a vaccine. In the interim we really just need to do enough to keep people alive and get the economy restarted.

I just can't understand why they wouldn't do a control group....it blows my mind really. They knew the Chinese study was out there with the control group in place. Maybe they were just over-confident in the results of that study but...it's really only muddying the waters for a lot of reasons. A control group would have given this study a lot more backbone. 

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Just now, seriously27 said:

I just can't understand why they wouldn't do a control group....it blows my mind really. They knew the Chinese study was out there with the control group in place. Maybe they were just over-confident in the results of that study but...it's really only muddying the waters for a lot of reasons. A control group would have given this study a lot more backbone. 

I think in this instance companies are trying to use the standard of care control, and compensate for the reduced statistical power that gives you by sharing data in consultation with regulatory bodies. 

It makes data interpretation a mess since instead of comparing everything to a blank, you're comparing everything to everything else.

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Just now, ramssuperbowl99 said:

The downside here is that it's IV only, and per the FDA since forever, that can only be done in a hospital.

Even still we are really talking about giving this to hospitalized patients anyway, right?    

The study seems to support 5 day use being just as effective as 10.  A 5 day IV drip is much shorter than most admitted patients are currently hospitalized and less labor intensive than putting someone with serious symptoms on a ventilator.  So if you can shorten time to recovery and reduce ventilator usage and all it takes is hooking someone up to an IV for 5 days, that's a huge win

I will say if this is proven effective and can be mass produce maybe the FDA needs to think about allowing other IV clinics to do this, although you'd have to weigh the cost benefit of having mildly symptomatic coronavirus patients leaving their house to get a treatment that may not even be needed for 99% of them.  My guess is its not worth it

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1 minute ago, ramssuperbowl99 said:
5 minutes ago, seriously27 said:

I just can't understand why they wouldn't do a control group....it blows my mind really. They knew the Chinese study was out there with the control group in place. Maybe they were just over-confident in the results of that study but...it's really only muddying the waters for a lot of reasons. A control group would have given this study a lot more backbone. 

I think in this instance companies are trying to use the standard of care control, and compensate for the reduced statistical power that gives you by sharing data in consultation with regulatory bodies. 

It makes data interpretation a mess since instead of comparing everything to a blank, you're comparing everything to everything else.

Am I crazy though?  NIAID study had a control group right?  What am I missing

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Just now, mission27 said:

Even still we are really talking about giving this to hospitalized patients anyway, right?    

The study seems to support 5 day use being just as effective as 10.  A 5 day IV drip is much shorter than most admitted patients are currently hospitalized and less labor intensive than putting someone with serious symptoms on a ventilator.  So if you can shorten time to recovery and reduce ventilator usage and all it takes is hooking someone up to an IV for 5 days, that's a huge win

I will say if this is proven effective and can be mass produce maybe the FDA needs to think about allowing other IV clinics to do this, although you'd have to weigh the cost benefit of having mildly symptomatic coronavirus patients leaving their house to get a treatment that may not even be needed for 99% of them.  My guess is its not worth it

Still a win, but a noteworthy caveat since unless someone looks it up they could think that it'd be as simple as getting a normal prescription. 

You could consider using some of the same sites for screening and dosing, worse come to worse. And yeah, the FDA has been getting badgered over their stubbornness on where things can be administered IV for a while now. With mAbs we finally have self-injecting pens, but that's IM/SC not IV.

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1 minute ago, ramssuperbowl99 said:

Still a win, but a noteworthy caveat since unless someone looks it up they could think that it'd be as simple as getting a normal prescription. 

You could consider using some of the same sites for screening and dosing, worse come to worse. And yeah, the FDA has been getting badgered over their stubbornness on where things can be administered IV for a while now. With mAbs we finally have self-injecting pens, but that's IM/SC not IV.

Definitely 

At the end of the day whether the studies are accurate or not, its clearly not a 'cure' that people can just go pick up a few pills and they'll be better a la antibiotics but it would help to solve the biggest challenge here which is how do you avoid hospitals getting overwhelmed and massive numbers of deaths if we see another spike in cases in a couple months post-reopening of the economy 

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5 minutes ago, mission27 said:

Am I crazy though?  NIAID study had a control group right?  What am I missing

Yes a second study supposedly did have a control but they have yet to release those results and the study supposedly took place after the first. Usually it's the other way around with the original test being based directly off a controlled placebo group. Without it, your results are basically like saying hey a bunch of these people got better by taking our drug but we can't really tell you if they would have gotten better if they hadn't. It is incredibly rare for a company to not do this first. 

Edited by seriously27
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Just now, seriously27 said:
5 minutes ago, mission27 said:

Am I crazy though?  NIAID study had a control group right?  What am I missing

Yes a second study supposedly did have a control but they have yet to release those results yet and the study supposedly took place after the first. Usually it's the other way around with the original test being based directly off a controlled placebo group. Without it, your results are basically like saying hey a bunch of these people got better by taking our drug but we can't really tell you if they would have gotten better if they hadn't. It is incredibly rare for a company to not do this first. 

We haven't seen the results but both Fauci and Gilead who have seen them or been briefed on them are saying the results are very positive'and Fauci is now saying this should be the new 'standard of care' going forward.  Seems to me Gilead held off on releasing the results of their own study to see how the NIAID study came out so they could comment on both at the same time and pulled the trigger once they realized the results were consistent.

Serious question though, isn't it hard to do a placebo controlled study on a drug with so much positive anecdotal evidence on an acute illness with high mortality, especially when that drug has an extensive compassionate use program in place?  If I were seriously ill I'd much rather get the drug on a compassionate use basis than participate in a controlled study and potentially get the placebo 

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