INHL - Inhale Therapeutics - Pulmonary Insulin! Message Board

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Biotech / Medical : INHL - Inhale Therapeutics - Pulmonary Insulin!

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To: tuck who wrote (199)	12/18/2001 8:50:20 PM
From: TheAlaskan	Read Replies (1) of 225

Would the additional testing set a precedent for competitive products to follow? ...and further delay competitive products into the market? After all, this is a new field of drug administration. It seems that Pfizer knew that two subjects already had signs of lung fibrosis before the clinical trial began. Therefore, would it not be realistic to know that additional work would be needed because of this inclusion? Pfizer stated that the lung fibrosis in these two patients was not related to Exubera. I would think that the parties would want sterile (except for the diabetes) clinical subjects for the trial. The risk to the clinical subject was minimal, so it should have been relatively easy to find willing subjects to choose from. Therefore, is the inclusion of these two subjects premeditated or carelessness? If it is not carelessness, then was it a calculated move to insulate the explosiveness and the rapid fielding of Exubura from competitive products that now must add additional testing to their FDA process as well? Especially if it is known that potential competitive inhaled products have alleged or potential lung fibrosis problems? biz.yahoo.com "The cases of lung fibrosis seen in two patients during clinical trials existed in those patients before the trials began and were not attributed to Exubera, a Pfizer spokeswoman said. Fibrosis is the marked by the development of excess connective tissue in an organ. Pfizer said the additional safety testing would end sometime next year, and it would file for approval with U.S. regulators after the trial was complete. In addition, Pfizer said it would include data relating to the potential side effects on the label for the new drug. Pfizer and France's Aventis SA are co-developing Exubera and plan to co-market the dry-powder insulin, which is vaporized and inhaled through a device created by Inhale. Insulin, taken by millions of diabetics around the world, is usually administered through injection. An inhaled form of the drug would offer a convenient alternative. The hormone insulin helps to regulate the amount of glucose, or blood sugar, in the bloodstream. Diabetics often lack sufficient amounts of insulin." I dunno, just trying to figure it all out. The company stock was crushed earlier with a previous delay. Could today's delay be planned?. I wonder who the big blocks were that were buying today. A lot of shares changed hands. Crafted strategy or carelessness? The Alaskan

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