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Biotech / Medical : VD's Model Portfolio & Discussion Thread -- Ignore unavailable to you. Want to Upgrade?

To: Harold Engstrom who wrote (8022)	6/19/2000 9:45:00 AM
From: rkrw	Respond to of 9719

<<TKTX filed their BLA based on data from 2 Phase II trials. they did not run a Phase III trial. Genzyme will reportedly file a BLA based on comprehensive Phase III trials within 2 weeks. FWIW, I had heard from good sources that there were a few defections from the Genzyme Fabry's program to the Transkaryotic Fabry's program a few months ago. I have no idea how to interpret the above, but my intuition gives the edge to Genzyme: they followed bureaucratic procedures while Transkaryotic is trying to cut corners. TKTX is getting a reputation (in my book) for not playing by the rules. That doesn't necessarily mean they don't have redeeming qualities, but what else might htey cut corners on?>>> What really matters is the FDA, not genz comments. We haven't seen either company's data, so who here can say who ran the more comprehensive trial, who has more compelling data, or who cut corners and who didn't? Perhaps it doesn't matter. This is a very niche indication and we'll find out soon enough what the FDA thinks of tkt's phase II or genz phase III for that matter. One point of note would be that this isn't necessarily a case of one company winning over the other. If the runnerup company can prove its product is different or better than the other's, they would be free to market given FDA approval.