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Non-Tech : Nabi (NABI) -- Ignore unavailable to you. Want to Upgrade?


To: Extra Pale who wrote (306)1/4/2001 1:48:39 PM
From: Torben Noerup Nielsen  Read Replies (1) | Respond to of 354
 
If any of you have problems with economic analysis applied to humans, try the same game on cows. The numbers are favorable even for limited protection.

Then suppose they find a way of increasing the effectiveness of the vaccine to 75% or so. Not too farfetched.

Disclaimer: I'm long NABI.

Torben



To: Extra Pale who wrote (306)1/21/2004 5:53:55 PM
From: Extra Pale  Respond to of 354
 
Nabi stock price is up 60% or so in last month. From following 12/03 press release, confirmatory staphvax phase III seems to have endpoints previously surpassed by prior phase III. European filing expected late this year with US filing in late 2005.

Lehman gave an overweight rec with price target of $25. Seems to me that Lehman is basically saying staphvax is slam dunk. Has anyone seen any current market projections (or willing to hazard a guess).

Nice to see Nabi bounce back (to 2000 prices) Is it nearing time to take profits?

"Nabi Biopharmaceuticals also announced that following recent discussions with the U.S. Food and Drug Administration (FDA), the company will increase the number of end-stage renal disease (ESRD) patients in the confirmatory Phase III trial of StaphVAX from 3,000 to 3,600. The decision to expand the sample size was made following additional dialogue with the FDA as to what would constitute a clinically meaningful effect in the context of the adverse event profile. The increase in trial size will strengthen trial's statistical power to demonstrate statistical significance with a clinical reduction of 50% or more in type 5 and type 8 Staph aureus infections through eight months post-vaccination. This is less than the 60% reduction rate used in the protocol for the previous Phase III trial.

For licensure in the US, Nabi Biopharmaceuticals' plan to file a Biologics License Application (BLA) with the FDA by the end of 2005 remains unchanged. The outside costs of the confirmatory Phase III trial are projected to total approximately $36 million and will be incurred from initiation of the trial in 2003 through its expected completion in the second half of 2005."