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Biotech / Medical : Zonagen (zona) - good buy?
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To: Dauntless who wrote (3345)4/9/1998 12:26:00 PM
From: Hank  Read Replies (2) of 7041
 
They didn't take place. Remember, Viagra was given fast track status because it offered a MAJOR improvement over current treatment because it is a pill. There was no need to do comparisons with Caverject. With Muse, you have the agruement that we're talking about a catheter application versus a needle. A minor point but still an improvement over Caverject (or perhaps not so minor depending on your level of tolerance!). What advantage does Vasomax offer over Viagra? 15 minutes versus and hour? Most people I know that have shown an interest in Viagra don't seem to mind that it takes an hour. Additionally, ZONA has to convince the FDA that this is a reliable expectation. If Vasomax was as efficacious as Viagra, then the 15 minute versus an hour agruement would be sufficient to gain approval. Since Vasomax isn't as efficacious as Viagra, it will have to find another angle. It will have to prove that it helps a significant portion of the population that don't respond to Viagra. This is especially true if the individuals that fail to respond to Viagra are already being successfully treated with Muse or Caverject. Otherwise, the FDA will give the drug low priority and sit on their hands while SGP and ZONA run in circles to generate more data. As I said before, the FDA's decisions are often subjective. If figuring out how they judge any one drug was as easy as reading their guidelines, we'd all know which drugs would be approved and rejected with certainty.

Hank
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