<<Isn't it true that because the NDA was not filed prior to Viagra approval, ZONA will have to go through the non-expedited approval process?>>
This is true and it was a scenario that Joe Podolski outlined in a conference call back in November of '97. At the time, he said the NDA would be filed by mid '98. He said that even if Viagra was approved by then and Vasomax could not get fast track status, he felt that Vasomax could still get approval in 1999, with a very clean label.
Since this was right after the Schering deal was announced, Schering knew about this and signed the deal anyway. They believe that Vasomax has some competitive advantages over Viagra and will be a significant drug for them. Despite the anonymous claims of special expertise by some on this board, I give far more credence to Schering's demonstrated commitment to Vasomax.
Is there anyone out there who really believes that 70% of all impotent men will be helped by Viagra? More likely, there will be many players in this field. Each will find their niche. None will be a magic bullet. Just as with injections, a combination therapy will probably work best and Vasomax could be a player, alone and possibly in combination with others.
In the last month we've had Zonagen mistakenly bad mouthed by an analyst, bashed in Fortune Magazine, sued by class action attorneys and inundated by the Pfizer hype machine with Viagra's approval. Yet the stock is holding up pretty well. The great majority of the insiders are holding their stock and there is no evidence of institutional selling. The interest being generated by Viagra will ultimately benefit all players in this sector. With about 13 million shares, fully diluted, Zonagen may be the best pure play in the impotence sector. Just my opinion, of course. |