Galena Biopharma, Inc. Message Board

Overview of Clinical Trials
Clinical trials are conducted to collect data regarding the safety and efficacy of new drug and device development. There are several steps and stages of approval in the clinical trials process before a drug or device can be sold in the consumer market, if ever.

Drug and device testing begins with extensive laboratory research which can involve years of experiments in animals and human cells. If the initial laboratory research is successful, researches send the data to the Food and Drug Administration (FDA) for approval to continue research and testing in humans.

Once approved, human testing of experimental drugs and devices can begin and is typically conducted in four phases. Each phase is considered a separate trial and, after completion of a phase, investigators are required to submit their data for approval from the FDA before continuing to the next phase.

Human Clinical Trial Phases
Phase I studies #$%$ the safety of a drug or device. This initial phase of testing, which can take several months to complete, usually includes a small number of healthy volunteers (20 to 100), who are generally paid for participating in the study. The study is designed to determine the effects of the drug or device on humans including how it is absorbed, metabolized, and excreted. This phase also investigates the side effects that occur as dosage levels are increased. About 70% of experimental drugs pass this phase of testing.

Phase II studies test the efficacy of a drug or device. This second phase of testing can last from several months to two years, and involves up to several hundred patients. Most phase II studies are randomized trials where one group of patients receives the experimental drug, while a second "control" group receives a standard treatment or placebo. Often these studies are "blinded" which means that neither the patients nor the researchers know who has received the experimental drug. This allows investigators to provide the pharmaceutical company and the FDA with comparative information about the relative safety and effectiveness of the new drug. About one-third of experimental drugs successfully complete both Phase I and Phase II studies.

Phase III studies involve randomized and blind testing in several hundred to several thousand patients. This large-scale testing, which can last several years, provides the pharmaceutical company and the FDA with a more thorough understanding of the effectiveness of the drug or device, the benefits and the range of possible adverse reactions. 70% to 90% of drugs that enter Phase III studies successfully complete this phase of testing. Once Phase III is complete, a pharmaceutical company can request FDA approval for marketing the drug.

Sentiment: Strong Buy

I went to the BIO site and it says that only 4.7% of CARDIOVASCULAR drugs get approved NOT oncology drugs. Once again a basher posts lies to mislead investors. I encourage all investors new to Neuvax to investigate any claim by these bashers. They NEVER provide a link.

Sentiment: Strong Buy

DD DD DD DD DD DD DD DD DD DD

Sentiment: Sell

people were telling me that same kind of thing with ARNA (a million or so bucks ago for me). You are looking at the wrong stat - this has very good P2 data, has a dev partner in Teva, another partner making dignostic machines, they filled up on cash, they will have an optimized P3 because they learned a lot in P2.
get in now, or #$%$.
ignored!

Sentiment: Buy

danny wants to "engage" LOL

Sentiment: Strong Sell

My guess is that chances for GALE are even lower.

Sentiment: Strong Sell

I thought you guys wanted to talk about "reality"?

Sentiment: Strong Sell