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Interesting, Abbott tests for 1 antibody. Not as comprehensive as AB Assurance...
Abbott's test helps to detect the IgG antibody to SARS-CoV-2. An antibody is a protein that the body produces in the late stages of infection and may remain for up to months and possibly years after a person has recovered. Detecting these IgG antibodies will help determine if a person was previously infected with the virus that causes COVID-19.
UHealth, University of Utah Antibody test
It appears they are using Abbotts IgG antibody to SARS-CoV-2
https://healthcare.utah.edu/healthfeed/postings/2020/04/antibody-testing.php
“Antibody testing will play an important role in the COVID-19 pandemic because it can tell us if a person has been exposed to SARS-CoV-2—even if that person never exhibited any symptoms or received a molecular diagnostic test,” says Julio Delgado, MD, ARUP Laboratories vice president, chief medical officer, and director of laboratories.
Learn more from ARUP Laboratories: Understanding the Role of Antibody Testing in Battling the Spread of COVID-19.
APR 15 2020
Abbott has launched its third test for coronavirus (COVID-19) and will start shipping it in the U.S.
The test is a serology test – also called an antibody test – which could be a critical next step in battling this virus.
Abbott's test helps to detect the IgG antibody to SARS-CoV-2. An antibody is a protein that the body produces in the late stages of infection and may remain for up to months and possibly years after a person has recovered. Detecting these IgG antibodies will help determine if a person was previously infected with the virus that causes COVID-19.
The new antibody test is to be used on Abbott's ARCHITECT i1000SR and i2000SR laboratory instruments, which can run up to 100-200 tests an hour.
What is your point? Don’t Make This Huge Mistake!!!
April 19, 2020 - 4:59 pm Newsletter
Don’t Make This Huge Mistake!!!
April 19, 2020 - 4:59 pm Newsletter
https://mdiconsultants.com/dont-make-this-huge-mistake/
To have the best chance of gaining coverage from insurers, the gold standard in study design is a large, prospective, multicenter, randomized controlled trial (RTC), preferably blinded. Most other clinical study designs are usually not accepted by payers because they involve too few patients and, although the results may be good, the study design used to arrive at the results is significantly flawed and unreliable. To spend hundreds of thousands of dollars on a study that at the outset is doomed to be inadequate to obtain coverage is a huge mistake. While conducting your clinical trial(s), it is important not only to generate the scientific evidence with validated and reliable results, but also to gather economic data for a cost-effectiveness analysis to present assurance to insurers that use of your medical device will decrease their overall costs.
Predictive’s COVID-19 Test Announcement Looks Like A Last-Ditch Sham To Salvage A Company On The Brink Of Insolvency - HB
https://regenexx.com/blog/predictive-biotech-and-an-eua-for-corecyte/
Does not refer to "naked" shorting:
KEY TAKEAWAYS
Short and distort (S&D) refers to an unethical and illegal practice that involves shorting a stock and then spreading rumors in an attempt to drive down its price.
S&D traders manipulate stock prices conducting smear campaigns, often online, to drive down the price of the targeted stock.
A short-and-distorter's scheme can only succeed if the S&D trader has some degree of credibility.
A 'short and distort' is the inverse of the better known 'pump and dump' tactic.
Totally disagree with you. Please review FOIA requests: These do not relate to Assurance AB, but stem cell products. Orthopedic surgeons are going to lose a huge revenue stream. The FOIA requests are trying to dig up dirt on PRED. Also see link https://regenexx.com/ Only can receive treatment in the Caymen Islands and does not use umbilicord extracted stem cells. Using the "short and distort" strategy:
https://www.investopedia.com/articles/analyst/030102.asp
1. Orthopedics This Week (Bill Donovan) PREDICTIVE BIOTECH, SALT LAKE CITY, UTAH - AMNIOCYTE CMPLNTS
Dr. William Donovan, MD
Orthopedic Surgery • Male • Age 77
Dr. William Donovan, MD is an orthopedic surgery specialist in Houston, TX and has been practicing for 47 years. He graduated from Loyola U, School of Medicine in 1968 and specializes in orthopedic surgery.
2. Kurt Weber Establishment inspection report for an inspection(s) occurring between January 1, 2017 through January 31, 2019 for: Predictive Biotech Salt Lake City, UT FEI: 3012707547
Facility FEI Number
The Facility FEI (FDA Establishment Identifier) Number data element is a number assigned by the FDA for tracking inspections.
3. Hindenburg Research LLC Form 483 and Establishment Inspection Report for Predictive Biotech based in Salt Lake City, Utah Form FDA 3356 in relation to the same company
Tissue Establishment Registration
Establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated solely under section 361 of the Public Health Service (PHS) Act are required to register with FDA pursuant to 21 CFR Part 1271. Establishments must register and list their HCT/Ps within 5 days of beginning operation and registration must be updated annually in December.
Yup
“It means we no longer have to put health care professionals at risk for infection by performing nasopharyngeal or oropharyngeal collections,” Andrew Brooks, chief operating officer and director of technology development at RUCDR said. “We can preserve precious personal protective equipment for use in patient care instead of testing. We can significantly increase the number of people tested each and every day as self-collection of saliva is more quick and scalable than swab collections. All of this combined will have a tremendous impact on testing in New Jersey and across the United States.”
Others can comment on the other products PRED offers. Do your homework
Stem cells.
Good one!
Trying to connect the dots:
EUA's for Labs and Manufacturers
Wellgistics receives an order and sends it off to the CLIA Pred lab who then orders from DaBlood. DaBlood ships the kits to Wellgistics for distribution.
Clinical Laboratory FAQs
Q: I am a clinical laboratory certified to perform high-complexity testing under CLIA and am interested in developing a SARS-CoV-2 test. What do I need to do if I make my own primers/probes or order the individual components?
A: Please refer to the Policy for Diagnostic Tests for Coronavirus Disease-2019.
The FDA encourages such laboratories developing tests, whether using purchased components or making their own primers/probes, to consider the validation recommendations in the guidance as they seek to validate their tests. If you pursue an alternate approach, we recommend discussing plans with us early, through the pre-EUA program. Please contact us at CDRH-EUA-Templates@fda.hhs.gov..
As stated in the guidance, the FDA does not intend to object to the use of validated tests for specimen testing for a reasonable period of time after validation while the laboratory is preparing an EUA request. The FDA believes 15 business days is a reasonable period of time to prepare an EUA submission for a test that has already been validated.
Test Kit Manufacturer FAQs
Q: I am developing a SARS-CoV-2 test kit for distribution to clinical laboratories. Can I follow the policy outlined in the Policy for Diagnostic Tests for Coronavirus Disease-2019?
A: The Policy for Diagnostic Tests for Coronavirus Disease-2019 as updated on March 16, 2020 now includes information applicable to manufacturers developing test kits for distribution. As stated in the guidance, the FDA does not intend to object to a commercial manufacturer's development and distribution of SARS-CoV-2 test kits for specimen testing for a reasonable period of time after the manufacturer's validation of the test and while the manufacturer is preparing its EUA request where the manufacturer provides instructions for use of the test and posts data about the test's performance characteristics on the manufacturer's website. Transparency can help mitigate potential adverse impacts from a poorly designed test by facilitating better informed decisions by potential purchasers and users. The FDA believes 15 business days is a reasonable period of time to prepare an EUA submission for a test whose performance characteristics have already been validated.
Question. If serology POC tests are EUA approved do they have be analyzed in high complexity CLIA labs?
Antibody tests typically come in either rapid versions that use a small amount of blood from a finger prick and may cost as little as $20 or less, or others that rely on traditional blood draws and cost considerably more. Many of the finger-prick ones are being marketed for use in doctors’ offices and pharmacies, even though the government requires that all unauthorized tests be run in so-called CLIA laboratories certified to conduct high complexity testing, Becker said.
That requirement is slowing use of the antibody tests, say suppliers who argue doctors should be able to run point-of-care tests in their offices without using sophisticated labs.
Thanks, whatever works best for you!
past performance does not guarantee future results
Great article (even tho I had to pay for it!!!)
Yes, it is the strategy that has worked for me. Holding one year is NOT long term IMHO
Seven years is what I have chosen as MY timeframe. I have known lots of daytraders/shorters lose their shirts. I have been successful. Your choice
Whatever works for them. I am a buy and hold long. I purchased this stock prior to seeing this board on my own DD. I plan on holding for a long time
My post was meant to educate regarding the buy and hold strategy. To each his own
Many legendary investors such as Warren Buffett and Jack Bogle praise the buy-and-hold approach as ideal for individuals seeking healthy long-term returns.
No reference to penny stocks.
https://asymmetryobservations.com/definitions/full-market-cycle/
Full Market Cycle
What is a full or complete market cycle? When we say “across a full market cycle” what do we mean?
A complete market cycle (or a full market cycle) is defined as a period of bull, bear, and bull periods generally lasting 4-5 years. The average bull market from 1937 to 2013 is about 39 months. The average bear market is about 17 months, which actually matches the most recent bear market from October 2007 to March 2009 (17 months). The average full market cycle is 56 months.
The 5 years from 2005 to 2010 is one of the greatest examples in history. During those years, stocks were rising sharply through 2007 and then reversed down over -50% and then moved back up nearly 70%. It was the highest volatility ever recorded since the Great Depression. That is true both in terms of the swings and the average daily range in prices. From April 2005 through April 2010 the S&P 500 stock index ended with a slight loss across the full market cycle. Many alternative investment strategies or alternative trading strategies have an absolute return objective to create profits across a complete market cycle rather than track a benchmark.
Buy and Hold Definition
By BRIAN BEERS
Updated Jan 16, 2020
What Is Buy and Hold?
Buy and hold is a passive investment strategy in which an investor buys stocks (or other types of securities such as ETFs) and holds them for a long period regardless of fluctuations in the market. An investor who uses a buy-and-hold strategy actively selects investments but has no concern for short-term price movements and technical indicators. Many legendary investors such as Warren Buffett and Jack Bogle praise the buy-and-hold approach as ideal for individuals seeking healthy long-term returns.
Buy and hold investment strategy. Most longs I know hang onto their investments for at least 7 years, matching the market cycle.
Mr. Stern, I couldn't agree more. I would also look at the political landscape
Agreed. All tests will need to be confirmed in the lab. This test is probably very expensive.
IMHO
https://www.fda.gov/media/136963/download
Chembio can finger stick test
Thanks Brian, this story has hit the Florida media....
bye bye HB/regenexx
Just don't understand how they can get away with this, touting stem cells...
https://regenexx.com/about-us/
There is no doubt in my mind that the orthopidists group is paying HB. They are a very powerful lobby, with money flowing into campaigns. IMHO
Well said. The "ignore poster" option is a wonderful thing
IMHO
Yes you do!
PRED needs a cash infusion. Please review Mr. Sterns post.
And I would think they are sitting on the Iqvia deal due to the massive efforts to obstruct by HB/Centeno
IMHO
Just to refute you... I come from the industry. PRED's testing methodology is solid. And they most certainly would not submit to the FDA for an EUA if they weren't validated. That would be the kiss of death. I assume the CDC did not submit their crappy virus detection test to the FDA.
I agree with you in most other points (HB, Centaro). The results/numbers question I believe is part of their strategy for a managed roll out and quick acceptance to the Nazzzy
IMHO
Could you please help me to understand OA studies? Do you mean QA studies?
Brilliant! Loved reading the study...
Wow! Thanks so much, it makes perfect sense now!
Thanks! I know my FDA, but just have a general knowledge of short selling.
Bid 0.985
Bid Size 2000
Ask 1.02
Ask Size 1206
So. if I interpret this correctly. The seller is asking for 1.02/share in 1206 allotments?
Thanks again
I'm just looking at today. Trying to figure out the bid and ask...
Don't have a clue about the outstanding shares. Above my pay grade