Event 2021 – Part 5 (Clinical Trials, C19 EUA, & Swine Flu scam)
1.) Phases of Clinical Trials
2.) Emergency Use Authorization for Vaccines to Prevent COVID-19 (FDA)
3.) If we don’t learn from history, we are destined to repeat it
4.) Swine Flu Extras
Phases of Clinical Trials
Phase one: Is it Safe?
Phase two: Is it Effective?
Phase three: Is it Better?
(Typically 10 years)
- Phase I – Determine Safety.
- Phase II (aka Exploratory Trials) – If a Safe Dose is Found – Does the Drug Work?
- Phase III – How does the drug compare with that already used for the problem? (This phase of research occurs when there is compelling evidence of efficacy & safety).
Demonstrate the drug is Effective & Safe in a larger number of patients in the target group (the people the drug is intended to treat). Monitor side effects & risks. Test different doses and different ways of giving the drug. Can the drug be used at different stages of the disease being treated – early, late .…Provide sufficient information about the drug for marketing approval -> FDA.
- Phase IV – Post Marketing Surveillance Studies (The long-term effect of the drug or treatment & other impact or use of the drug.)
Emergency Use Authorization for Vaccines to Prevent COVID-19 (FDA)
The Emergency Use Authorization document. Issued in Oct 2020. Non-binding recommendation. Doesn’t place the FDA or the public under any obligation.
These are the Emergency Use Authorization requirements:
These are critical. If any of these 4 get knocked-out, EUA (Emergency Use Authorization) dies.
The problem is, there ARE adequate treatments.
By “definition”, the EUA doesn’t exist.
The PCR-Tests – Gone.
The Emergency-Vaccines – Gone.
If we don’t learn from history, we are destined to repeat it.
Plays an old (1979) segment from CBS ’60 Minutes’ on the swine flu (also known as H1N1) & the vaccine that was developed to stop the pandemic.
Truth-seeker, ever-questioning, ever-learning, ever-researching, ever delving further and deeper, ever trying to 'figure it out'. This site is a legacy of sorts, a place to collect thoughts, notes, book summaries, & random points of interests.