You make some good points. The morning after pill and cyclamates are good examples. The thing is that Vasomax has been approved in Mexico for over a year now and they have no sales. Also, there has been no useful data, as far as we know. The lack of sales is the most important issue to me. If it were that good, the people who tried it in the first quarter would have reordered. They didn't! The first quarter had big sales, the next zero, the next a small negative in the form of returns and the fourth quarter again zero sales. So there is no repeat business.
Brazil is a new approval. They have no other approvals, but UK is in process, FWIW. Viagra has had problems getting prescribed in the UK and I would expect it would not be easier for Vasomax there.
Thalidomide is not really a good example of approval for labeling, since it's been approved for life-threatening ailments like leprosy. I would not think that the FDA would be likely to take chances for Vasomax where there are already more efficacious oral meds on the market. Still, Thalidomide is an example of a labeling approval. :)
The problem is that their data was always questionable, very doubtful. They worked on it for a really long time before submitting. Now they are trying to find more data, but if it were there it might have been already found and submitted. They weeded patients on nitrates out of their studies before, and they don't have data on the subject yet that they are willing to talk about. The company has overstated what it has for a long time, so I doubt they have evidence that they have a better safety profile than Viagra. It seems to me, too, that they will need that, if the drug doesn't work as well as Viagra.
Linda |
