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Microcap & Penny Stocks : CELSION CORP. (CLN was CELN) UP $.33 TO $.59 ON HUGE NEWS -- Ignore unavailable to you. Want to Upgrade?

To: Larry Brew who wrote (256)	1/31/1999 10:01:00 PM
From: Dave Gore	Read Replies (6) \| Respond to of 518

Report back from Biotech specialist...votes "No" on CELN....says company is no more interesting than others in same Breast cancer area that are already in Phase 2 or 3 trials. Of course many of you will disagree because their treatment is less invasive. He is by nature a bit more conservative than some of you, but not unfamiliar with the BB market at all. We both feel it could run up tomorrow, because the MM's want that so they can short it, and make money both ways. In fact he thinks that if the stock goes up tomorrow, it will be "shorted mericilessly". I am waiting to see if he minds me posting his exact response or part of it. I am sure he will be okay with me posting the information on Phase I, II, III and IV/advanced III trials. He does say that there are many areas along the way that a company can get tripped up and several years are required.(for example: unexpected development of severe mastitis adjacent to treatment site, higher incidence of local recurrence, etc.). Here is the PHASE info: The clinical testing of experimental drugs is normally done in three phases, each successive phase involving a larger number of people. Once the FDA has granted a New Drug Approval (NDA), pharmaceutical companies also conduct post marketing or late phase three/phase four studies. A Phase One Study: Phase I studies are primarily concerned with assessing the drug's safety. This initial phase of testing in humans is done in a small number of healthy volunteers (20 to 100), who are usually paid for participating in the study. The study is designed to determine what happens to the drug in the human body--how it is absorbed, metabolized, and excreted. A phase I study will investigate side effects that occur as dosage levels are increased. This initial phase of testing typically takes several months. About 70 percent of experimental drugs pass this initial phase of testing. A Phase Two Study: Once a drug has been shown to be safe, it must be tested for efficacy. This second phase of testing may last from several months to two years, and involve up to several hundred patients. Most phase II studies are randomized trials. One group of patients will receive the experimental drug, while a second "control" group will receive a standard treatment or placebo. Often these studies are "blinded"--neither the patients nor the researchers know who is getting the experimental drug. In this manner, the study can provide the pharmaceutical company and the FDA comparative information about the relative safety of the new drug, and its effectiveness. Only about one-third of experimental drugs successfully complete both phase I and phase II studies. A Phase Three Study: In a phase III study, a drug is tested in several hundred to several thousand patients. This large-scale testing provides the pharmaceutical company and the FDA with a more thorough understanding of the drug's effectiveness, benefits, and the range of possible adverse reactions. Most phase III studies are randomized and blinded trials. Phase III studies typically last several years. Seventy to 90 percent of drugs that enter phase III studies successfully complete this phase of testing. Once a phase III study is successfully completed, a pharmaceutical company can request FDA approval for marketing the drug. Post-Marketing -- Late Phase Three/Phase Four Studies In late phase III/phase IV studies, pharmaceutical companies have several objectives: (1) studies often compare a drug with other drugs already in the market; (2) studies are often designed to monitor a drug's long-term effectiveness and impact on a patient's quality of life; and (3) many studies are designed to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies.