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

To: Michael Young who wrote (1480)	1/3/1998 4:36:00 PM
From: Dauntless	Read Replies (1) \| Respond to of 7041

And a friendly hello to you too, Mike - and let me wish you a Happy New Year as well. You started with >> "You are talking nonsense." You then wrote (CAPS are mine): >> "The FDA is OFTEN involved to SOME extent in trial design" If you haven't done so before, you should 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". If you read it through 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. ===================================================================== IMHO, your comment that "You are talking nonsense" might be better directed to someone else. It simply does not pay to stray too far from the "suggestions" of the FDA during the review meetings that a company has along the way - especially if it's a new company working on their first submission. My experience is that you pretty much do what they suggest - because the final submission is going right back to the same people - and they have long memories. The real point is that some people are making flat out statements that the trials were bogus by the fact that the protocols were changed from one study to the next. The company has stated on several occasions that the trial protocols were changed to comply with FDA suggestions. The above information, quoted from the FDA, says that's normal. And even if the company DID make changes like some suggest, how would anyone know about it - that's very confidential that you won't get it from the company or the agency. On the other hand, there's nothing offered to PROVE that something's shady - just loud, never ending accusations & innuendoes. Perhaps if they are repeated often enough they will become valid - even my teenagers have outgrown that virtual reality.