Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

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

To: Dauntless who wrote (3326)	4/6/1998 12:20:00 PM
From: Hank	Read Replies (1) \| Respond to of 7041

"The FDA site does indicate that they consider relative efficacies for two drugs aimed at the same market." That is completely untrue. I told you to go look at the section under Regulatory Guidance that deals with the statistical guidelines for establishing efficacy. In this section, they talk about conducting clinical trials between two drugs in order to establish the EQUIVALENCE OR SUPERIORITY of the new drug to it's nearest comparator. Why would they establish guidelines like this if the relative efficacy of two drugs designed to treat the same condition was not a factor in their decision making process? They may not try to select the best drug but they do weed out inferior ones. If Vasomax can not prove that it is at least equivalent to Viagra in the general population, then the FDA will not approve it. On the other hand, if SGP wants to claim that Vasomax is useful for patients that do not respond to Viagra or is efficacious when used in combination with Viagra, that's fine. However, the FDA isn't going to take their word on this, especially if the overall efficacy of Vasomax is significantly less than Viagra. They will have to prove this by conducting additional clinical trials. This is particularly true if, as Brad has said, some Dr's want to use the two together since it hasn't even been shown that they are safe to take together. SGP knows this and that is why they worded the statements about Vasomax the way they did. Anybody who tells you the FDA is going to approve Vasomax if it shows any degree of efficacy at all does not know what they are talking about. Hank