Replies to post #130249 on NanoViricides Inc (NNVC)

[arvitar]

First, NNVC is years away from running a clinical trial, hence this information is entirely irrelevant.

Second, if one wants to understand the FDA guidelines and how they matter for their investment, they need to read *the* FDA guidelines. Not watered-down one-sentence explanations for sick patients who might lack high school education.

And they need to learn about the risks, costs, and times of completing FDA trials, as provided by the FDA:



http://www.fdareview.org/03_drug_development.php

[Ubertino]

Understanding Clinical Trials
What are clinical trials?
A clinical trial is a research study to determine whether new drugs or treatments are safe and effective in humans. Carefully conducted clinical trials are the fastest and safest way to find treatments that work.

Here are some terms that you need to know as you learn about clinical trials:

Placebo
A placebo is an inactive (or "dummy") pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness.
Control Group
In many clinical trials, one group of patients will be given an experimental drug or treatment, while another group, the control group, is given the conventional treatment.
A Blind Study
A blinded study is one in which participants do not know whether they are in the experimental or control group in a research study.
A Double-Blind
Study A double-blinded study is one in which neither the participants nor the study staff know which participants are receiving the experimental treatment and which ones are getting a standard treatment. These studies are performed so neither the patients' nor the doctors' expectations about the experimental drug influence the outcome.
Side Effects
Side effects are any undesired actions or effects of a drug or treatment. Such effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.

Some sentence!!

[Ubertino]

Understanding Clinical Trials
What are clinical trials?
What are clinical trial phases?
Clinical trials of experimental drugs proceed through four phases:

Phase I
Clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase II
Clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
Phase III
Studies, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase IV
Studies are done after the drug or treatment has been approved for marketing. These studies continue testing the study drug or treatment to collect information about its effect in various populations and any side effects associated with long-term use.
Who sponsors clinical trials?
Who can participate in a clinical trial?
Guidelines
What is a protocol?
What happens during a clinical trial?
How are clinical trial volunteers protected?
What are the benefits of participating in a clinical trial?
What are the risks of participating in clinical trials?
What should I know before I join a clinical trial?
What should I know as a participant in a clinical trial?