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Biotech / Medical : Alexion Pharmaceuticals, Inc. (ALXN) -- Ignore unavailable to you. Want to Upgrade?


To: rkrw who wrote (383)11/10/2003 4:07:57 PM
From: Ian@SI  Respond to of 824
 
After listening to the conference call, I still don't get it.

The phase III indicates that there will be about 4000 fewer US deaths annually using Pex compared with not using it.

Using the total population in the study, the results are significant. But it seems that because a pre-defined subset isn't significant (i.e. about a 1 in 15 chance of pure luck whereas the desirable level is less than 1 chance in 20.), thus another study will be required prior to seeking approval.

Assuming a 2 year delay in approval, 8000 excess US deaths will have occurred - almost 3 September 11th tolls. Amazing.



To: rkrw who wrote (383)11/10/2003 6:47:17 PM
From: Miljenko Zuanic  Read Replies (1) | Respond to of 824
 
<<I'd guess the probably not-so-prospectively defined secondary endpoints >>

Do you need to be critical all the time?

Target was 30% reduction in in death/MI, and nowhere in PR is noted. Also, I was hoping for ~50% reduction in mortality, or at least 2% points (absolute).

Data are worse than I was speculating early.
Message 19200155
Message 19196679

and <<IF you take Bell’s comment on CONSISTENCY as granted, than my take is that there was not significant benefit in all-cause mortality while Pexe did reduce non-fatal MI. Which would explain valve group contribution to overall result. However, this will reduce their marketing advantage, as mortality is great factor than MI.>>

Message 19193345

Jan, you are mixing tomato and orange.

Miljenko

PS: ALXN management is join Zudija club