Pretty quiet hereGuess the circle-jerk-gang are sucking their own thumbs...lol In an article posted Apr 4 of this year, "Investigational new drug application. Later, TheraLase expects to move the research and development process up a gear with an investigational new drug application to the Food & Drug Administration for a Phase II clinical study in the US." Off the FDA.GOV site Phase 1 studies are usually conducted in healthy volunteers. The goal here is to determine what the drug's most frequent side effects are and, often, how the drug is metabolized and excreted. The number of subjects typically ranges from 20 to 80. Phase 2 Phase 2 studies begin if Phase 1 studies don't reveal unacceptable toxicity. While the emphasis in Phase 1 is on safety, the emphasis in Phase 2 is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. For controlled trials, patients receiving the drug are compared with similar patients receiving a different treatment--usually an inactive substance (placebo), or a different drug. Safety continues to be evaluated, and short-term side effects are studied. Typically, the number of subjects in Phase 2 studies ranges from a few dozen to about 300.Phase 3 Clinical Trial Icon At the end of Phase 2, the FDA and sponsors try to come to an agreement on how large-scale studies in Phase 3 should be done. How often the FDA meets with a sponsor varies, but this is one of two most common meeting points prior to submission of a new drug application. The other most common time is pre-NDA--right before a new drug application is submitted. Phase 3 studies begin if evidence of effectiveness is shown in Phase 2. These studies gather more information about safety and effectiveness, studying different populations and different dosages and using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people. Postmarket requirement and commitment studies are required of or agreed to by a sponsor, and are conducted after the FDA has approved a product for marketing. The FDA uses postmarket requirement and commitment studies to gather additional information about a product's safety, efficacy, or optimal use. Last time I asked about who would pay for a Phase ll trial, and that Phase ll Trials involved double blind testing, placebo and control groups, pumptards here claimed that is not the case with TLT. Wowsers, right up there with "Efficacy is not an issue" & next NR after first treatment of 3 patients, SP will be > $1