Covid-19 (not gnr related)

[jarmo]

Good news, try it on them first.    But why can they speed up the approval process and the FDA isn't even talking about it until the 10th?

The rest of the world is wondering the same.





/jarmo

[cineater]

Good news, try it on them first.    But why can they speed up the approval process and the FDA isn't even talking about it until the 10th?

The rest of the world is wondering the same.





/jarmo

We thank them for their service. 

Just trying to keep spirits bright.  This really does suck.  All the hospitals are full again.  Businesses are closing up.  And of course people are dying.

[pilferk]

Good news, try it on them first.    But why can they speed up the approval process and the FDA isn't even talking about it until the 10th?

Read back.  I explained why.

The process is legally codified.  The FDA have to follow it.

Other sovereign nations have different processes. 

[tim_m]

Good news, try it on them first.    But why can they speed up the approval process and the FDA isn't even talking about it until the 10th?

The rest of the world is wondering the same.





/jarmo

We thank them for their service. 

Just trying to keep spirits bright.  This really does suck.  All the hospitals are full again.  Businesses are closing up.  And of course people are dying.

It's getting bad here again. We crossed a 7 day threshold that requires us to rollback capacity or close entirely. My county is seeing daily numbers it didn't even see in the spring. Yesterday we had 490, today 471 with 4 deaths. I know that doesn't sound too bad, but I'm in a rural county with population of only 900k.

[cineater]

Good news, try it on them first.    But why can they speed up the approval process and the FDA isn't even talking about it until the 10th?

Read back.  I explained why.

The process is legally codified.  The FDA have to follow it.

Other sovereign nations have different processes. 

Yeah I remember, "the process".  What part of the process did the FDA expedited, speed up, to meet this crisis?  Did they work evenings and weekends?  Do some preliminary reviews of the data so they'd have a head start when the request for approval came in?  I'm sure there's nothing in the law that prevents them from busting butt like so many others have done knowing lives are on the line.

[cineater]

Good news, try it on them first.    But why can they speed up the approval process and the FDA isn't even talking about it until the 10th?

The rest of the world is wondering the same.





/jarmo

We thank them for their service. 

Just trying to keep spirits bright.  This really does suck.  All the hospitals are full again.  Businesses are closing up.  And of course people are dying.

It's getting bad here again. We crossed a 7 day threshold that requires us to rollback capacity or close entirely. My county is seeing daily numbers it didn't even see in the spring. Yesterday we had 490, today 471 with 4 deaths. I know that doesn't sound too bad, but I'm in a rural county with population of only 900k.

It finally hit the rural areas.  Back in the spring it was mostly in the cities.  I'm in a secondary county.  They shut down the city and the primary county and we didn't have it much out here in the spring.  But it's here now and they are starting close down measures.  We keep going the way we are I can see a shutdown after Christmas.  It's pretty quiet out there now as it is.  I'm doing all my shopping online or curbside pickup.  I can tell by the increase in email and texts a lot of people are at home.

[tim_m]

Good news, try it on them first.    But why can they speed up the approval process and the FDA isn't even talking about it until the 10th?

The rest of the world is wondering the same.





/jarmo

We thank them for their service.  

Just trying to keep spirits bright.  This really does suck.  All the hospitals are full again.  Businesses are closing up.  And of course people are dying.

It's getting bad here again. We crossed a 7 day threshold that requires us to rollback capacity or close entirely. My county is seeing daily numbers it didn't even see in the spring. Yesterday we had 490, today 471 with 4 deaths. I know that doesn't sound too bad, but I'm in a rural county with population of only 900k.

It finally hit the rural areas.  Back in the spring it was mostly in the cities.  I'm in a secondary county.  They shut down the city and the primary county and we didn't have it much out here in the spring.  But it's here now and they are starting close down measures.  We keep going the way we are I can see a shutdown after Christmas.  It's pretty quiet out there now as it is.  I'm doing all my shopping online or curbside pickup.  I can tell by the increase in email and texts a lot of people are at home.

In my county just the other day we were down to 243 beds in the ENTIRE county only 11 of which are ICU beds, not good at all. Our rollback is only to 50% and only bars and restaurants that are mandated to close are ones who have more then 15% of their business be alcohol. We don't have the brightest bulb in the box as a governor. Our deputy chief constable just the other day died from covid. A out of state friend of mine lost one of her cousins yesterday to covid. I am so over this virus. That's 6 friends of mine who have lost a combined 13 family/friends/co-workers etc.

[pilferk]

Good news, try it on them first.    But why can they speed up the approval process and the FDA isn't even talking about it until the 10th?

Read back.  I explained why.

The process is legally codified.  The FDA have to follow it.

Other sovereign nations have different processes.  

Yeah I remember, "the process".  What part of the process did the FDA expedited, speed up, to meet this crisis?  Did they work evenings and weekends?  Do some preliminary reviews of the data so they'd have a head start when the request for approval came in?  I'm sure there's nothing in the law that prevents them from busting butt like so many others have done knowing lives are on the line.

But there actually is.  The expedited process has a pretty specific timeline codified in it.  They have to do specific things, in a specific order, and there are specific durations for some of those phases (like review and comment).

They can't pre-review study data until it's submitted, which is part of the application process.  You can't study data you don't have (and aren't supposed to have because it's not final).

They have literally gone and are going as fast as the law allows them to.  Three weeks from submissions for emergency approval is INSANELY fast in terms of FDA approval, and is pretty much as fast as Emergency Use applications can be performed.

Feel free to argue that the law and process are too lengthy. I won't disagree.  You'll have to take that up with the largely Republican influenced legislation that governs it.

But the answer to your question is: The codified process for the FDA, for Emergency Use Applications, carries with it a very specific process and durations that pretty much mean 3 weeks is about as quick as they can turn around a vaccine approval.

Other countries have different processes that allow them to work more quickly.

[cineater]

Good news, try it on them first.    But why can they speed up the approval process and the FDA isn't even talking about it until the 10th?

Read back.  I explained why.

The process is legally codified.  The FDA have to follow it.

Other sovereign nations have different processes.  

Yeah I remember, "the process".  What part of the process did the FDA expedited, speed up, to meet this crisis?  Did they work evenings and weekends?  Do some preliminary reviews of the data so they'd have a head start when the request for approval came in?  I'm sure there's nothing in the law that prevents them from busting butt like so many others have done knowing lives are on the line.

But there actually is.  The expedited process has a pretty specific timeline codified in it.  They have to do specific things, in a specific order, and there are specific durations for some of those phases (like review and comment).

They can't pre-review study data until it's submitted, which is part of the application process.  You can't study data you don't have (and aren't supposed to have because it's not final).

They have literally gone and are going as fast as the law allows them to.  Three weeks from submissions for emergency approval is INSANELY fast in terms of FDA approval, and is pretty much as fast as Emergency Use applications can be performed.

Feel free to argue that the law and process are too lengthy. I won't disagree.  You'll have to take that up with the largely Republican influenced legislation that governs it.

But the answer to your question is: The codified process for the FDA, for Emergency Use Applications, carries with it a very specific process and durations that pretty much mean 3 weeks is about as quick as they can turn around a vaccine approval.

Other countries have different processes that allow them to work more quickly.

I've been part of those government processes, hence the anger.  The process excuse is something we said to the outside but it didn't mean people on the inside weren't having a full blown bitch fest about it.    Something like this will change the process in the long run.  Don't worry about the legislation, they aren't looking at how it's actually done.  Their worry is how to protect themselves from lawsuits and the cost.  You just have to troubleshoot through all their concerns and it will fly.  They like to look like they have made improvements.

[cineater]

Are we still supposed to let packages coming into the house sit for a while?

[pilferk]

Are we still supposed to let packages coming into the house sit for a while?

Later guidance said probably not. Virus cant live on packaging surfaces for more than a couple hours, max. If its a direct from amazon delivery...because it was likely packaged recently...maybe put it in the garage for an hour or two. Wash your hands after handling the package...and dont, you know, lick it...and you should be fine.

[cineater]

Are we still supposed to let packages coming into the house sit for a while?

Later guidance said probably not. Virus cant live on packaging surfaces for more than a couple hours, max. If its a direct from amazon delivery...because it was likely packaged recently...maybe put it in the garage for an hour or two. Wash your hands after handling the package...and dont, you know, lick it...and you should be fine.

Will do.  Never occured to me to lick it but now that you mention it, I may never look at the Amazon guys the same way again. 

[tim_m]

So today sucks, my best friend found out her brother has covid-19 and he's got an underlying heart condition.

[tim_m]

The Moderna vaccine has shown to still provide antibody response 3 months later, very encouraging news.

[cineater]

So today sucks, my best friend found out her brother has covid-19 and he's got an underlying heart condition.

Is he hospitalized? 

[tim_m]

So today sucks, my best friend found out her brother has covid-19 and he's got an underlying heart condition.

Is he hospitalized? 

He was rushed to the ER because he was puking, that was what prompted them to do the covid test. They only gave him nausea meds and sent him home. this is is in Tennessee their healthcare system sucks. He has no insurance either so he's got to go to the only hospital that will see him.

[jarmo]

The UK is supposed to start their vaccinations tomorrow.




/jarmo

[cineater]

So today sucks, my best friend found out her brother has covid-19 and he's got an underlying heart condition.

Is he hospitalized? 

He was rushed to the ER because he was puking, that was what prompted them to do the covid test. They only gave him nausea meds and sent him home. this is is in Tennessee their healthcare system sucks. He has no insurance either so he's got to go to the only hospital that will see him.

Any word on how he's doing?

[tim_m]

So today sucks, my best friend found out her brother has covid-19 and he's got an underlying heart condition.

Is he hospitalized? 

He was rushed to the ER because he was puking, that was what prompted them to do the covid test. They only gave him nausea meds and sent him home. this is is in Tennessee their healthcare system sucks. He has no insurance either so he's got to go to the only hospital that will see him.

Any word on how he's doing?

So far ok, he's been able to eat.

[cineater]

So today sucks, my best friend found out her brother has covid-19 and he's got an underlying heart condition.

Is he hospitalized? 

He was rushed to the ER because he was puking, that was what prompted them to do the covid test. They only gave him nausea meds and sent him home. this is is in Tennessee their healthcare system sucks. He has no insurance either so he's got to go to the only hospital that will see him.

Any word on how he's doing?

So far ok, he's been able to eat.

Good direction to be going.  So if he has a heart condition why wasn't he on Obama care? 

I assume he's not eligible for TennCare?  That's the name of medicaid in Tennessee.  Never made that name connection before.  Wonder if they had something to do with each other or just a coincident?

They say our numbers are starting to go down.  I hardly call a difference of less the 10 and indication of going down when you're talking a couple hundred.  They are still holding their breath over a Thanksgiving spike.

Aw, everybodies grandma was the first to get the shot.