Dauntless,
I think SGP's game plan may be to try and get Vasomax approved based on the angle that it will help those that do not respond to Viagra. The only problem is, they will have to conduct head to head clinical trials with Viagra and Vasomax to prove this. Since Viagra is only now hitting pharmacy shelves, they obviously could not have done these types of studies yet. Therefore, the FDA would have to rule based on the efficacy of Vasomax in the general ED population as compared to Viagra. Since the evidence shows that Vasomax is NOT more effect than Viagra in the general population, the FDA will not approve Vasomax initially. However, it is very likely that the FDA will send SGP and ZONA back to the drawing board in order to conduct the head to head trials I just mentioned. Should all this prevent SGP from filing an NDA right away? No, because while they are gearing up for the inevitable head to head trials that they will undoubtedly be required to perform, they can also field any objections to the existing clinical data that the FDA may have. In other words, they can can address all concerns at once in order to expedite the process.
The only problem with this whole scenario is that it will take another year to complete head to head trials of Viagra versus Vasomax. That will extend the potential approval date of Vasomax well into the 21st century. In the mean time, it allows other competitors to play catch up and gives Viagra the chance to gain a strong foothold. The failure of Vasomax to gain immediate approval by the FDA will also send ZONA stock into a tail spin. In the final analysis, you are looking for a very long wait before you MAY see a return on your investment and a consistant per share earnings growth from ZONA, assuming that ZONA can gain better control of it's burn rate.
As for the Pfizer sales persons comments on Vasomax, it would be expected since Vasomax is the only potential competition that is prepared to file an NDA soon. Pfizer is merely covering their backs in the event that Vasomax does gain immediate approval. Regardless of whether they really believe it will or not, this is just sound business practice. I don't think you can consider this an opinion as to whether or not Vasomax will gain immediate approval. These, of course, are all my opinions but I'd be surprised to see it play out any other way.
Hank |
