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

To: Hank who wrote (3339)	4/8/1998 1:15:00 AM
From: Steve H.	Read Replies (1) \| Respond to of 7041

The specific reference is: fda.gov Statistical Principles for Clinical Trials Section: 3.3.1 Trials to Show Superiority and section: 5.2.3 Roles of the All Randomized Subjects Analysis and the Per Protocol Analysis What can we logically conclude from this information? 1) The FDA does have something to say about the way studies are conducted on compounds that attempt to show superiority or equivalence to existing compounds. 2) For "Serious Illnesses" lack of a head-to-head study would be considered unethical by the FDA and, we could safely conclude, would result in non-approval. While there are guidelines for conducting head to head studies, it seems that the actual requirement for such studies is not necessarily mandated unless the treatment is for a "Serious Illness". The requirements for Vasomax clin. trials would hinge on the FDA's definition of "Serious Illness". I expect that there are a variety of opinions on this, but it is safe to conclude that MED is not life threatening. A good comparison might be antipsychotics. Are new compounds required to do head-to-head clinical trials against approved compounds (that are fundamentally different molecules - as is the case with Vasomax and Viagra) with the same indications? Hank? OTOH, I may just be Naive and as F. Jay Abella, III says in message #3333, Vasomax will just get burried in paperwork (which is different from your assertion, Hank even if the result is the same). FTR, I now have no position on ZONA and I am still long on PFE.