Peter.......... you need to walk before you can run. AGPH couldn't focus on two PI studies because they needed to first get their *single* PI approved by FDA. In teaming with Roche, they partnered with the company that has most experience (together with Abbott) in "two PI" studies. Will they need to go through another 6 months of testing? No, I don't think so............. once approved, a certain number of physicians will experiement with the combinations, IMO. However, a large, longer-term clinical trial would certainly help with market penetration, yes.
Drugs are marketed by "detail reps", advertising, etc. The reps are trained to play down deficiencies in their products and to hit on areas where their product has real or perceived advantages. There's a certain ammount of drug success that is determined by marketing clout, and AGPH will have a _relative_ deficiency here. However, the best drug usually wins market share, and, in this case, we're dealing with an activist patient population. So, IMO, yes, AGPH has what it takes (a superior product and, now, a business plan with muscle) to pull it off in the U.S. I'm certain, however, that Merck will not suddenly release ads that say "take Viracept, it's better than crix".
AGPH has been building a sales presence for about 1 1/2 years. They had hired three project managers as of 11/95. Originally, they were targeted for Thymitaq, but the business plan did an about-face in early '96. It's, to me, remarkable that such a small company had such flexibility....... a testiment to the strong business plan.
Rick |