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Biotech / Medical : NPSP NPS Pharmaceutical -- Ignore unavailable to you. Want to Upgrade?


To: tuck who wrote (216)3/30/2004 9:25:17 AM
From: tuck  Read Replies (2) | Respond to of 363
 
Raw CC notes; answers paraphrased, don't quote me quoting management or Dr. Lindasy (responses by him in parentheses):

>>PE vertebral fractures: data on a per-patient not a fracture basis. Fractures mild, only one patient had two fractures.

Use relative to Forteo? (Dr. Lindsay) Await approval. Lots of asymptomatic women at high risk, as well as use in severe patients

Why not statistical significance at 12 months, and for fractures elsewhere? Study not powered for this.

Injector pen to be used in launch better than one used in trial. Wouldn't say how for competitive reasons.

Partner? Certainly for ex-US. Co-promotion or alone in US. Partner could be brought in earlier or later.

Did DSMB make any decisions regarding hypercalcemia? (Dr. Lindsay) Algorithm for hypercalcemia worked well, and EKGs were basically negative.

Label? Too early.

More results? Scientific meeting and publication, details not now, but "shortly." >3 months.

In severe group (prior fracture), fracture reduction "in line" with overall population. Statistically significant.
# of fractures in the group not released, so % reduction not calculable (expect this at meetings, journals)

NDA by year end; rate limiting steps? Lots of data to analyze from TOP and other trials.

Other trials comtemplated.

Poison pill still in place.<<

Not much beyond the press release, except for the data concerning severe fractures. The stock got almost to $32 when I was watching the pre-market shortly after that came out. I pulled the trigger and sold mid $31. The play worked OK for me ($4 over cost basis in four weeks), and I'm not sorry I got up early. Whew!

Cheers, Tuck