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Biotech / Medical : Zonagen (zona) - good buy? -- Ignore unavailable to you. Want to Upgrade?

To: Dauntless who wrote (1461)	1/1/1998 2:41:00 PM
From: Dauntless	Read Replies (1) \| Respond to of 7041

FDA info #2 More goodies from the FDA web site: Go to the following FDA website fda.gov I urge you to browse around , but make sure you look at the link "Benefit vs Risks: How the FDA Approves New Drugs". There you will find the following: ================================================================== FDA participates actively in the drug development process, seeking to provide clear standards and expectations. Sponsors are encouraged to meet with FDA, Temple says, at an "end of phase 2 conference" before carrying out the large-scale controlled clinical trials. (For information about the various phases of drug study, see "Testing Drugs in People.") At this conference, FDA gives advice about the design of the sponsor's study plan to ensure that the trials will be acceptable. As Temple puts it: "We try to find and eliminate flaws in the individual studies and overall development plan that we know will give us trouble later on in the NDA review. We don't want people to carry out a large study that has no chance of being considered adequate and well-controlled." FDA also provides advice, he says, in the form of guidelines on how to study particular classes of drugs and on how to submit and analyze data in a marketing application. In addition, to ensure that institutional review boards meet FDA's rules for the protection of the rights and welfare of research subjects, the agency routinely inspects the boards every five years. "We may go more often, if there are problems," says Frances O. Kelsey, Ph.D., M.D., director of FDA's division of scientific investigations. ================================================================== Now, how well does this description of the process fit with the accusations that the Zonagen Clinical trials were a sham, obfuscated, statistically insignificant, etc. How did Zonagen ever complete Phase III trials? Another attack has been that Zonagen has changed the definition of the "successful end point" of their trials from one phase to the next. Does that now make a little more sense to anyone? Once again, real information from - as Al Gore would say - "the controlling legal authority". Or as I submit, from the horse's mouth, instead of ..... well... let's just say.... the other end of the horse. Don't want to offend Barb, now do we?? ;-)

To: Dauntless who wrote (1461)	1/1/1998 5:29:00 PM
From: Dante Sinferno	Respond to of 7041

<<almost no insider selling at either of these companies>> That's why I pose the question...how are the perpetrators making money from these frauds ? Show me the money. Rob

To: Dauntless who wrote (1461)	1/1/1998 7:52:00 PM
From: Bill Wexler	Respond to of 7041

For suckers who bought ZONA at its high..... 60% of shareholder value has been eliminated. Zona has never produced any earnings. Zona has never produced any products of value. Zona does not have an effective ED drug. Zona continues to lose millions of dollars. Zona is estimated to lose at least $3 a share in 1998. Zona has done nothing except sell more stock. Zona will soon trade in the low single digits. No matter how many names you drop, Clueless, absolutely nothing will change these facts.