To: RWReeves who wrote (6765 ) 5/14/1999 6:13:00 AM From: Linda Kaplan Read Replies (2) | Respond to of 7041
Hi. That's an interesting point of view. Can you elucidate? What are the many places in the world where it can be freely sold? And why do you think it hasn't been sold there if it can be? Why would they prefer to stockpile it? Regarding the US not being necessarily critical to making money, can you name some drugs that have made money without approval here? I'm genuinely interested. I wonder why you think that ZONA has a fair chance at approval? Can you name any drugs that were approved after receiving a non-approvable letter? You know they had a long long time to prepare their data. They'd completed their studies several years before they submitted it to FDA. Then they had another year after submission. It would seem to me that if they had some evidence that would ensure approval, they'd have submitted it. They FDA was not going to approve and they backed off because they had nothing convincing they hadn't already provided. They mentioned they have some completed studies they didn't submit and some that are incomplete. But if the completed studies offered something of value, they'd have given them to the FDA. Realistically, we already know that there efficacy of this drug is very weak. They cannot show that the drug has few side effects because we already know the drug has plenty of side effects. We have nausea, vomiting, dizziness, tachycardia. Those side effects are caused by Vasomax. There's no reason to believe it doesn't have the same problems with nitrates that Viagra has! ZONA was mum about that, though asked during the conference call. Well, they were desperate for something positive to say, but they could not say that it handles nitrates better than Viagra even then. I expect it does not. Linda