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

To: Dauntless who wrote (3281)	4/1/1998 11:40:00 PM
From: Brander	Respond to of 7041

Dauntless, concerning the FDA information, I agree with you. The main thing the FDA looks for is whether or not the drug is safe and efficacious. A drug does not have to be markedly better than another to be approved. Almost every class of drugs has multiple alternatives to choose from, and many are equally efficacious with similar side effect profiles. An example of such a drug recently approved (made by a company I have stock in--unfortunatley in this case) is Quadramet (Samarium-153). It was approved by the FDA late last summer. The Medical Letter Panel reported the following just after it's approval: "Limited data indicates that samarium-153 lexidronam is effective in relieving the pain of osteoblastic bone metastases in some patients. It offers no demonstrated clinical advantage over strontium-89, which has been used much longer for this indication." If the FDA only approved drugs which were significantly better than others, it would lead to long periods of stagnation and monopolies. The only case where the question of significantly better efficacy would be heavily weighted is whether or not the drug would receive rapid approval. Brad

To: Dauntless who wrote (3281)	4/2/1998 12:40:00 PM
From: Hank	Read Replies (1) \| Respond to of 7041

Ok Dauntless. I concede that the FDA leaves open the possibility of approval of a drug on an "as good as" basis. However, I can only tell you that when it comes down to decision time, the final verdict is often very subjective on the part of the FDA. It is MUCH more difficult for a drug company to get approval for a new drug that is only "as good as" rather than "better than". In the case of Vasomax, I also concede that they may have a slight advantage in this regard because there is only one other drug on the market to offer competition. If there was a glut of ED pills on the market, they would have a much harder time getting approval even if they proved Vasomax to be as good as Viagra. Unfortunately for ZONA, I don't think they will be able to prove Vasomax is as good as Viagra based on the available data. There are no exceptions in the FDA literature wherein they are willing to approve drugs that are LESS effective than the current treatment unless the new drug is shown to help patients that could not be treated otherwise. I still firmly believe that ZONA will wind up having to conduct dual clinical trials with Vasmoax and Viagra in order to find a nitch. There is also some information on the FDA web site regarding these types of studies under the subject heading Regulatory Guidance- Statistical Methods for Determining Efficacy. In this section they talk about comparing the new drug versus a comparator in order to determine superiority or equivalence. So you see, I can admit it when I've overstated the case. In fact, I am the one that told you to go to the FDA web site in the first place. I didn't come here to bully anyone, as some would suggest, but to air my view point. If you check through the posts, you'll find that I was unceremoniously attacked when I first posted here, not with counter arguments but with insults. I've made my points clear and I am still very much short. I won't bother to post here as much in the future but I'll still be reading. When I see facts stated incorrectly, I will correct them. You are welcome to treat me the same way. I just wonder if you will all have the nerve to acknowledge I was right if a year from now things have played out just as I said they would. Hank