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03-20-2020, 07:01 PM

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Originally Posted by misterpoole View Post
And Trump 'feels good about it'.... His hopes hunches and feelings are irresponsible. He also has said its 'under control' and 'will disappear'. Trump needs to try shutting up.
Please leave this on NPR..to keep the inmates confined
I'm not sure why you responded to me in that manner. I did not post the thread nor can I move it. I posted valid information from a highly qualified expert. Me. There was nothing political in it, but there certainly is in your response.

Of course the thread should be moved. Tell a moderator or admin.


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03-21-2020, 07:50 AM

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Originally Posted by Chopdoc View Post
What exactly do you do in pharma?

Your description of the process is erroneous.

There are provisions for accelerating the process. They have been used in the past and are being used now.

The first human trial for a vaccine started last Monday.

Yeah and there are 3 stages of trials required. IF that is a good vaccine and is given Fast track status, it will still be a year before it is available-more likely 15 months to 2 years.
  
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03-21-2020, 08:29 AM

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Originally Posted by Nostroke View Post
Yeah and there are 3 stages of trials required. IF that is a good vaccine and is given Fast track status, it will still be a year before it is available-more likely 15 months to 2 years.
That's very interesting and I have seen others presenting that information.

We had a pandemic that started in January 2009. The first Phase I human testing of a vaccine began in July 2009. (Again, the first human trial of vaccine for this current virus started this past Monday...mid-March.)

The vaccine was implemented in November of 2009. 3 billion doses in fact.

That pandemic lasted until August 2010, so the vaccine was available widely well before the end of the pandemic.

In addition, our capabilities and capacities to create, produce, and disseminate vaccines increase every year. That was eleven years ago.

This does not mean we definitively will have success, but we do have the very realistic potential to not only do it again, but to do it faster and better. At this point, it is the more likely scenario rather than the one you paint, which is possible but less likely now.

Something is wrong with what you think you understand or perhaps what you have heard or read somewhere.

I think it is unlikely intentional on your part, I do think you have been misinformed or have simply looked in the wrong places for information.

.


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03-21-2020, 09:22 AM

Quote:
Originally Posted by Chopdoc View Post
That's very interesting and I have seen others presenting that information.

We had a pandemic that started in January 2009. The first Phase I human testing of a vaccine began in July 2009. (Again, the first human trial of vaccine for this current virus started this past Monday...mid-March.)

The vaccine was implemented in November of 2009. 3 billion doses in fact.

That pandemic lasted until August 2010, so the vaccine was available widely well before the end of the pandemic.

In addition, our capabilities and capacities to create, produce, and disseminate vaccines increase every year. That was eleven years ago.

This does not mean we definitively will have success, but we do have the very realistic potential to not only do it again, but to do it faster and better. At this point, it is the more likely scenario rather than the one you paint, which is possible but less likely now.

Something is wrong with what you think you understand or perhaps what you have heard or read somewhere.

I think it is unlikely intentional on your part, I do think you have been misinformed or have simply looked in the wrong places for information.

.

I've been buying biotech stocks for 25 years plus and had to live through many trials for new drugs and they take well over a year. Perhaps flu vaccine trials are different as 'flu vaccines' themselves have already been determined to be safe. That's just my guess. DR Fauci in a press conference pretty much said what i did.
  
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03-21-2020, 10:15 AM

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Originally Posted by Nostroke View Post
I've been buying biotech stocks for 25 years plus and had to live through many trials for new drugs and they take well over a year. Perhaps flu vaccine trials are different as 'flu vaccines' themselves have already been determined to be safe. That's just my guess. DR Fauci in a press conference pretty much said what i did.
Maybe you should stop buying "biotech" stocks for a bit, because the race is on to make $$$$. You should be well versed in Theranos being a "biotech" invstor, so here's their early efforts in patent trolling post-epidemic sales...

https://regmedia.co.uk/2020/03/18/theranos.pdf
also...
https://patents.google.com/patent/US10533994B2/en

In other news a man 3D printed a part to help combat low supply, now's he's being threatened with lawsuits. The part originally costs $11,000, his version that can be printed out directly by hospitals cost 11,000x less.... $1.

https://metro.co.uk/2020/03/16/firm-...ives-12403815/

The money race is on, first with a vaccine wins!!!

Any federal regulation approval process is out the window for _immediate_ pandemics, how is that not historically obvious? People don't depend on a federal approval process to have their lives saved during pandemics, they never have... ever (in fact, that defeats the entire purpose of the W.H.O., Doctors Without Borders, PeaceCorp., etc...).

Lastly, the presented information here with the vaccine for H1N1 is either FUD or yet more he-said-she-said. Tamiflu not only existed prior to H1N1 but was approved years before the 2009 outbreak. BTW, Tamiflu is _STILL_ recommended (along with something new to me called Zanamivir, which is apparently better).... https://en.wikipedia.org/wiki/Influe...s_subtype_H1N1 Spreading gossip about COVID-19 is 1 thing, but you can't do that with H1N1, too many of us have read too much about it (it's been 10 years!!).

Oh, the the fatality rate is now at a all time low for COVID-19 in the USA.
Total cases: 15,219
Total deaths: 201

201/15219 = .013...

So if your 65 or older and have contracted it, you have at worst a 98.7% chance to live.

Last edited by Cron; 03-21-2020 at 10:24 AM. Reason: Adding hopefully hopeful news.
  
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03-21-2020, 03:29 PM

Quote:
Originally Posted by Cron View Post
Maybe you should stop buying "biotech" stocks for a bit, because the race is on to make $$$$. You should be well versed in Theranos being a "biotech" invstor, so here's their early efforts in patent trolling post-epidemic sales...

https://regmedia.co.uk/2020/03/18/theranos.pdf
also...
https://patents.google.com/patent/US10533994B2/en

In other news a man 3D printed a part to help combat low supply, now's he's being threatened with lawsuits. The part originally costs $11,000, his version that can be printed out directly by hospitals cost 11,000x less.... $1.

https://metro.co.uk/2020/03/16/firm-...ives-12403815/

The money race is on, first with a vaccine wins!!!

Any federal regulation approval process is out the window for _immediate_ pandemics, how is that not historically obvious? People don't depend on a federal approval process to have their lives saved during pandemics, they never have... ever (in fact, that defeats the entire purpose of the W.H.O., Doctors Without Borders, PeaceCorp., etc...).

Lastly, the presented information here with the vaccine for H1N1 is either FUD or yet more he-said-she-said. Tamiflu not only existed prior to H1N1 but was approved years before the 2009 outbreak. BTW, Tamiflu is _STILL_ recommended (along with something new to me called Zanamivir, which is apparently better).... https://en.wikipedia.org/wiki/Influe...s_subtype_H1N1 Spreading gossip about COVID-19 is 1 thing, but you can't do that with H1N1, too many of us have read too much about it (it's been 10 years!!).

Oh, the the fatality rate is now at a all time low for COVID-19 in the USA.
Total cases: 15,219
Total deaths: 201

201/15219 = .013...

So if your 65 or older and have contracted it, you have at worst a 98.7% chance to live.
Cases are now at 22,177, doubling every 1.8 days so you have old figures -You are saying that 'past performance' is a predictor of the future when people haven't even had this thing in the USA long enough to die? (other than the initial small number of cases)

https://www.arcgis.com/apps/opsdashb...23467b48e9ecf6

Last edited by Nostroke; 03-21-2020 at 03:32 PM.
  
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03-21-2020, 04:07 PM

Quote:
Originally Posted by one stroke View Post
Well Trump cut miles of red tape to speed up the process ,
Lie.

Quote:
seems like a arthritis and malaria drugs is something they are looking into
,
Lie.

Quote:
but a new break though will take far less time than the normal
Lie.

You know how I know those are lies? Because the stupidest human being on the planet, President Trump, said them. Everything President Trump says should be considered a lie until proven otherwise. Any smart gambler would take even money that 2/3 of those statements are lies.

Last edited by 7stud; 03-21-2020 at 09:20 PM.
  
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03-21-2020, 04:13 PM

Trolls everywhere.
  
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03-21-2020, 06:23 PM

This is not close to a cure and vaccine can take up to a year if they find one that actually works
  
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03-21-2020, 06:29 PM

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Originally Posted by garczar View Post
That won't happen here. Book it.
So I watch Judge Janeen Piro Show, they I would retract that bet.


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03-21-2020, 07:35 PM

.........................................

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03-21-2020, 07:36 PM

.........................

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03-21-2020, 09:26 PM

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Originally Posted by Chopdoc View Post
What exactly do you do in pharma?

Your description of the process is erroneous.

There are provisions for accelerating the process. They have been used in the past and are being used now.

The first human trial for a vaccine started last Monday.
I work in CMC as a process chemist. CMC stands for chemistry, manufacturing, and controls. I am responsible for manufacturing active pharmaceutical ingredients (API’s) for clinical trials as well as for commercial use. We have to adhere to regulatory guidelines set forth by The ICH, FDA, EMA, as well as other regulatory agencies throughout the world.

My description of the approval process was correct, just very abbreviated. I can’t tell you exactly how vaccine trials work, because I work with small molecules API’s. Before you get to clinical trials you have to do several animal studies to show you are getting the desired response as well as toxicology studies. Generally clinical trials are run in three phases. Phase 1 is a small trial looking at the safety of the drug. Phase 2 is larger and looks for efficacy read outs as well as safety. Phase 3 is a much larger study than phase 1 or 2 and looks for efficacy read outs as well as safety. Then you have your regulatory filings and approval decision time. That alone can take 6 months to a year if not more. This is a simplified explanation. If you get orphan designation you can start combining phases. For example, a program I worked on for a rare type of brain cancer combined phases 1 and 2. Fast track status allow for accelerated approval by given priority review status and a greater frequency of meetings with the FDA to discuss data as well as developments plans. You can also get breakthrough therapy designation which allows intensive guidance from the FDA as early as phase 1. Last but not least, you can get accelerated approval for an unmet medical need (ie COVID-19). A new small molecule in development, that hasn’t been previously approved by the FDA, will not be approved in time to help this outbreak, even with the provisions in place. This is still an abbreviated explanation, and doesn’t cover the manufacturing challenges that an accelerated approval brings.

You are correct that provisions are in place to speed up the development and approval process. I know that the FDA is working diligently with COVID-19 vaccine development offering guidance and priority review. As I mentioned, I don’t know how vaccine trials work exactly, but they still have to show safety and efficacy. When I say efficacy I mean statistically significant response than that of the control group. I do know that this can occur at a much more rapid pace that that if a small molecule trial. My point was that unless, this pandemic lasts a year, which it may, we won’t have a vaccine to help. Given the rate of infections, who knows we may develop herd immunity before that, given the virus doesn’t mutate again.

In my opinion the best chance we have is a currently approved drug or combinations of drugs. As you know, a physician can prescribe any approved medication they see fit if they believe it will help. As you already know, we are seeing clinical readouts from hydroxychloroquine alone and in combination with the antibiotic azithromycin in a very small clinical study. A cursory look shows the combination of hydroxychloroquine and azithromycin May show some benefits. However, when you dig deeper into the data, 6 out of the 26 patients dropped out of the treatment arm of the trial, 3 went to the ICU, 1 dropped out due to nausea, 1 apparently recovered, and 1 died. That is 23% of the trial to drop out and very significant. This data though does suggest need for a larger more controlled study. I just hope that the generic manufacturers have very good histories with audits from the FDA as well as other regulatory agencies so the product coming out is up to standards.

Sorry for the long winded response!


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I do not like it, and I am sorry I ever had anything to do with it. Erwin Schr?dinger (1887-1961) Austrian physicist. Nobel Prize, 1933. Speaking of quantum mechanics.
Those who are not shocked when they first come across quantum mechanics cannot possibly have understood it. Niels Henrik David Bohr (1885-1962) Danish physicist.

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03-22-2020, 03:45 AM

One thing for sure. We have some people on here who are a lot smarter and provide us with better information than L'Orange.


http://www.jayhelfert.com/ to order More Pool Wars
  
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03-22-2020, 12:48 PM

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Originally Posted by jay helfert View Post
One thing for sure. We have some people on here who are a lot smarter and provide us with better information than L'Orange.
Indeed. Clearly no one on the planet with an IQ above room temperature and normal decency and moral sensibilities would have performed as described in the written text of this fully-documented timeline:

https://time.com/5805683/trump-admin...n-coronavirus/

Arnaldo


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