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7 minutes ago, ramssuperbowl99 said:

They're all set to skip Phase 2 and go right to Phase 3. All we need now is proof of large scale immunity.

Yeah I'm not very sciencey at all but I thought what I read was very encouraging. This being an mRNA means this is massive on many levels since we don't have any mRNA vaccines in the wild. Am I right here?

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28 minutes ago, BobbyPhil1781 said:

Yeah I'm not very sciencey at all but I thought what I read was very encouraging. This being an mRNA means this is massive on many levels since we don't have any mRNA vaccines in the wild. Am I right here?

It means that there are additional potential issues since it's a new mechanism of action for a drug so there's a slight additional risk with this compared to a normal vaccine at this stage, but yeah it's a landmark that we've been able to take the concept of RNA interference and turn it into a working vaccine.

Granted, there were some adverse events so it's not like everything went perfectly, but they got a huge immune response at all of the dose levels and even the 250 ug dose was tolerated without any serious AEs, so I don't see why they could go with the 100 ug dose.

Edited by ramssuperbowl99
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On 7/13/2020 at 7:55 AM, WizeGuy said:

I signed up for a vaccine trial at my hospital. They're going to test for an immune response. I haven't been selected yet, so it's not a guarantee I'll even get it. I'm honestly around so many vulnerable people where I work that I want so bad to build some immunity from this virus. Any questions I should ask before accepting? It's at the University of Rochester, which has a very reputable research program. 

If you are interested, here's the clinical protocol from the study that was just linked. In my experience, this one looks pretty standard - they're all this thorough. 

https://www.nejm.org/doi/suppl/10.1056/NEJMoa2022483/suppl_file/nejmoa2022483_protocol.pdf

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52 minutes ago, ramssuperbowl99 said:

they got a huge immune response at all of the dose levels and even the 250 ug dose was tolerated without any serious AEs, so I don't see why they could go with the 100 ug dose.

Really good news, and we all need some of that

I read that the response was much stronger after the 2nd dose, so its a fair guess there will be both an initial vaccination and then a booster shot.
Given that, there may be reasons to go with the lower dose (25 ug)so you don't run into supply issues in making sure you have enough for everyone to get 2. Compliance will also be an issue, making sure everyone shows up twice is no small task

Edited by Shanedorf
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9 minutes ago, Shanedorf said:

Really good news, and we all need some of that

I read that the response was much stronger after the 2nd dose, so its a fair guess there will be both an initial vaccination and then a booster shot.
Given that, there may be reasons to go with the lower dose (25 ug)so you don't run into supply issues in making sure you have enough for everyone to get 2. Compliance will also be an issue, making sure everyone shows up twice is no small task

Yeah you're getting about 7x the response for twice the dose, so either the initial response is high enough for 1 dose on it's own and you can safely say the second one is overkill, or you go in for 2 doses. Granted I don't see a ton of human ADA data, but a titer of 40k in the low dose is massive. I'd say we could assume that's enough immune activity to prevent an infection.

The other thing to note is that while the response went way up in the 2nd dose, so did the number of AEs. They may be able to end up dosing more safely as a single dose of 100 ug instead of 2 doses at 25 ug. The immune response would be ~3.5x lower and you dosed more TA, so that's not great, but you might come out ahead in terms of alleviating safety concerns if the difference between the immune responses doesn't have any practical significance.

Edited by ramssuperbowl99
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15 minutes ago, Shanedorf said:

Really good news, and we all need some of that

I read that the response was much stronger after the 2nd dose, so its a fair guess there will be both an initial vaccination and then a booster shot.
Given that, there may be reasons to go with the lower dose (25 ug)so you don't run into supply issues in making sure you have enough for everyone to get 2. Compliance will also be an issue, making sure everyone shows up twice is no small task

Yeah with all the bickering and hypocritical BS going on in this thread, I felt the need to post it lol. I'm gonna keep lurking until I find something else that I feel is generally positive. Hopefully you'll be seeing me post in here again in a timely manner. That's not up to me though. 

I agree getting people to show up twice is a problem bc getting people to show up once is. I'm looking at the data, as little as I understood, it seemed the larger dose showed the most side effects especially in terms of severity while it wasn't needed. The fact that antibodies were produced at every level is great to see. I'm gonna quit pretend I know WTF I'm talking about now. I'll just keep reading you people's thoughts whom are smarter than I am lol. Not sure if y'all Reddit or not but r/covid19 is purely science driven with no BS and heavily moderated. You guys would probably benefit from it much more than I do when I rarely stroll in there.

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29 minutes ago, BobbyPhil1781 said:

I'm looking at the data, as little as I understood, it seemed the larger dose showed the most side effects especially in terms of severity while it wasn't needed. The fact that antibodies were produced at every level is great to see.

You're thinking about it the right way - the term we use to illustrate what you're getting at here is called safety margin, which is the difference between your effective dose level and toxic dose level. In this case, 250 ug was questionably tolerated, but 25 ug was effective, so we have at least a 10-fold difference. 

The stuff I saw that was good news in there:

  1. Every dose produced a response in 45/45 patients, and every dose level was tolerated even though 250 ug didn't stick the landing.
  2. There were some adverse events, and the list of symptoms of the adverse events are pretty common for an immune response. You tend to get nausea, a slight fever, pain, etc. If we didn't see anything even when the doses got super high, that actually might be a concern that the vaccine isn't really doing anything. It's counter-intuitive, but in a way that's good news.
  3. The measured immune response was huge at every dose. They measured for specific antibodies for COVID-19 immunity and reported titer units, and without getting into it too much, a titer unit is the amount the sample could be diluted and still test positive. The 25 ug dose had a titer of 40,000, meaning you could dilute it 40,000x and it would still be positive. The high dose after the second injection was 1.2 million. That's a **** ton of antibodies.

    It's worth noting that ADA tests are somewhat variable. I'd take any of those titer numbers with a grain of salt simply because they're so big. That said, they used two different ADA methods, which means they ran the samples two different ways and still got the same results both times. The odds of one test being a false positive are small, but there. The odds of both methods being junk are exponentially smaller.
  4. It's also important to show that there is a dose-response curve, that as you increase the dose from 25 to 250 ug, we see a corresponding increase in effect. In this case, we do at all levels, so we can correlate the increased immune response with the safety issues, and set a dose level to get us the highest immune response we can in the safest way we can.

tl;dr I'm very confident this thing works. ET buy this one up.

EDIT: Their stock price closed at $71 and is currently $87 on google's after trade index.

Edited by ramssuperbowl99
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3 minutes ago, ramssuperbowl99 said:

You're thinking about it the right way - the term we use to illustrate what you're getting at here is called safety margin, which is the difference between your effective dose level and toxic dose level. In this case, 250 ug was questionably tolerated, but 25 ug was effective, so we have at least a 10-fold difference. 

The stuff I saw that was good news in there:

  1. Every dose produced a response in 45/45 patients, and every dose level was tolerated even though 250 ug didn't stick the landing.
  2. There were some adverse events, and the list of symptoms of the adverse events are pretty common for an immune response. You tend to get nausea, a slight fever, pain, etc. If we didn't see anything even when the doses got super high, that actually might be a concern that the vaccine isn't really doing anything. It's counter-intuitive, but in a way that's good news.
  3. The measured immune response was huge at every dose. They measured for specific antibodies for COVID-19 immunity and reported titer units, and without getting into it too much, a titer unit is the amount the sample could be diluted and still test positive. The 25 ug dose had a titer of 40,000, meaning you could dilute it 40,000x and it would still be positive. The high dose after the second injection was 1.2 million. That's a **** ton of antibodies.

    It's worth noting that ADA tests are somewhat variable. I'd take any of those titer numbers with a grain of salt simply because they're so big. That said, they used two different ADA methods, which means they ran the samples two different ways and still got the same results both times. The odds of one test being a false positive are small, but there. The odds of both methods being junk are exponentially smaller.
  4. It's also important to show that there is a dose-response curve, that as you increase the dose from 25 to 250 ug, we see a corresponding increase in effect. In this case, we do at all levels, so we can correlate the increased immune response with the safety issues, and set a dose level to get us the highest immune response we can in the safest way we can.

tl;dr I'm very confident this thing works. ET buy this one up.

Thanks for taking the time to write this up. If you're encouraged, I'm getting the wife ready to start planning the party for when this thing is officially shown the door. I understand it potentially won't be for many months but hey, any kind of optimism is welcomed at this point especially when there's rumors Dewine is about to shut down Ohio again.

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15 minutes ago, ramssuperbowl99 said:

tl;dr I'm very confident this thing works. ET buy this one up.

Got my next stimmy buy. Better than a deep freezer, IMO. Not as cool as a crossbow or a massage chair, though.

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5 hours ago, Xenos said:

Lawyers get a lot of grief but I’m glad your clients have someone like you. 

Totally forgot if you already mentioned this but did you and family find out if you contacted Covid? 

I did find out.  Got a negative after 11 days of quarantining anyway.

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Awesome. Country is going to vilify teachers for being scared during a pandemic. This whole thing is insane.
 
Edit - Removed tweet. Look up JasonSCambell if you want to watch it. It’s an interview on FOX and it’s legit insane lol
Edited by MookieMonstah
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