Corona virus drugs on the horizon. Encouraging updates for players + loved ones

Nostroke

AzB Silver Member
Silver Member
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...nt-coronavirus-equipment-save-lives-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/Influenza_A_virus_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/opsdash...qjVWT8uzhFY#/bda7594740fd40299423467b48e9ecf6
 
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7stud

AzB Silver Member
Silver Member
Well Trump cut miles of red tape to speed up the process ,
Lie.

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

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.
 
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scsuxci

AzB Silver Member
Silver Member
This is not close to a cure and vaccine can take up to a year if they find one that actually works
 

Chembry

AzB Silver Member
Silver Member
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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jay helfert

Shoot Pool, not people
Gold Member
Silver Member
One thing for sure. We have some people on here who are a lot smarter and provide us with better information than L'Orange. :grin:
 

arnaldo

AzB Silver Member
Silver Member
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Scott Lee

AzB Gold Member
Gold Member
Silver Member
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.

24 hours later, and the death toll is 320. We have NO idea where this is going to end.

Scott Lee
2019 PBIA Instructor of the Year
Director, SPF National Pool School Tour
 

Nostroke

AzB Silver Member
Silver Member
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 just heard for the 2nd time that 12- 18 months is aspirational from Fauci- Then a vaccine MFR stepped in and said it is usually 10-25 YEARS!

Too bad you aren't on the GAL
 

alstl

AzB Silver Member
Silver Member
I suspect when a test to determine immunity becomes available we will discover far more people have had covid 19 and are perfectly fine than has been reported and the people who shut down the economy will look like idiots.
 

Nostroke

AzB Silver Member
Silver Member
I suspect when a test to determine immunity becomes available we will discover far more people have had covid 19 and are perfectly fine than has been reported and the people who shut down the economy will look like idiots.

You suspect? YOU??? Ahahahaha
 

lakeman77

AzB Silver Member
Silver Member
Working on them is great, and big incentive, figure they make buck or two a pill? times billions.
 

Cron

AzB Silver Member
Silver Member
I suspect when a test to determine immunity becomes available we will discover far more people have had covid 19 and are perfectly fine than has been reported and the people who shut down the economy will look like idiots.

First, I'm all for getting on with life and returning to normal SNAFU. But, I can wait a little longer too, so I guess I'm on the fence.

2nd, No one is immune, but as the contracted cases rise, so does the guesstimate % of people who have contracted it but show no symptoms, last I checked it was nearing 70%.

All that said, nobody looks like idiots yet (but they could wind up looking naive).

The fatality rate is back up to 3.4%, and the last I looked it was at 2.2%. A 1.2% swing in about 2 or 3 weeks is very large.
Take the cenus guesstimate that states every 10 years the population increases by 10% AND this magically is also the increase of risk per group (the CDC data shows it's probably a much higher risk... almost factually).
Assume if the fatality rate turns out to be 5% as expected.
Understand that 5% is for all ages.
Also understand that 5% is the safest/best number for people over 59.
Then you can take a guess at fatality, but a safe guess (or at least a rationall assumption).
Starting with people > 59... 5% of 60-69... 5.5% 70-79.... 6.05% 80-90.
That could be 16.55% of all people over the age of 59. Practically, imagine 1 in 5 people you know or don't know but smply see over the age of 59... dead... just gone.... and this is at BEST!!

Sure, I'm just guessing 16.55%, I don't deny that **. But in science, it's all about the best guess, and this guess wouldn"t be ruled out very quickly on the table of best guesses. Nobody will wind up looking like idiots. Now people could wind up looking incredibly naive if this quarantine lasts until say the end of the year. Sad to say but at this point COVID-19 is everywhere, so hide if you want, but if you ever step outside again.... But even with that said, the point of quarantine is almost always to wait for the cure/vaccine. But see I can flip that again. What if a vaccine is found, will it be highly effective for the > 59 group? I fear it won't be and the fatality numbers for this group will wind up looking like plain influenza. I fear the only way for this whole thing to not wind up looking like influenza is to never go outside again... but time will tell.

** I have to guess because the .pdf the CDC releases doesn't appear to give enough information to derive it,. The .pdf basically stops at using a ratio of 1:100,000.
 
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Scott Lee

AzB Gold Member
Gold Member
Silver Member
...and two weeks later, the US death toll stands at 17,000. That's 50X what it was two weeks ago. Like I said, we have NO idea where this is going to end! Stay Home!

Scott Lee
2019 PBIA Instructor of the Year
Director, SPF National Pool School Tour

24 hours later, and the death toll is 320. We have NO idea where this is going to end.

Scott Lee
2019 PBIA Instructor of the Year
Director, SPF National Pool School Tour
 

lakeman77

AzB Silver Member
Silver Member
A good friend who is in the medical biz told me they figure the fatality rate doubles for every decade over 60.
What that starting number is might be anybody guess. 1%, 3%, 5% ?
 

Cron

AzB Silver Member
Silver Member
A good friend who is in the medical biz told me they figure the fatality rate doubles for every decade over 60.
What that starting number is might be anybody guess. 1%, 3%, 5% ?

Sounds right to double. I started at 5% because that is/was the project fatality rate for COVID-19 across all ages. Obviously it's higher the older you get, so 5% should/could be the absolute best after factoring out all the < 59. It would be no problem for the CDC to list the ages of those who've died, but I can't find it. With such a huge set of fatalities and contractions, it is now pretty age to predict a lot of things... if you had the data.

Since this is the strongest isolation event since the Cuban missile crisis, I would like to run the numbers as much as I know how. I mean 427,460 cases... we're now past 1/1000th of the US population, well within prediction (it's kind of strange though to think if you are in a building with 1000 people, somebody probably has it).
 
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