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


To: Madharry who wrote (293)8/5/2003 3:13:16 AM
From: Icebrg  Read Replies (1) | Respond to of 824
 
>>Am i interpreting this correctly that if A is the subclass of CABG without valve replacement and B is the subclass of CABG with valve replacement. that the endpoint was not achieved for A but it was achieved for A+B. is that how you understand it as well?>>

Yes, that seems to be the case. This would normally be a good result if it hadn't been for the fact that the phase II trial showed the opposite result. I.e no statistical significance for the whole population, but significance in the CABG-arm only. Now things are getting rather confused. Let's hope they have a good explanation for this.

>>is it possible that the patients which only need CABG are alot healthier than the second group and therefore the mortality rate is very small to begin with?>>

That is what one would assume. If it hadn't been for the phase II results.

>>I am suspicious that the institutions will know before that what is going on. and will be able to make much more informed decision than us poor relatives.>>

Institutions will normally be a step ahead. They are able to employ expertise, we don't even know exist. How well they use this to their advantage is another matter. In the current situation, I think they are as perplexed as we are.

>>is it common for these pr releases to be so cryptic>>

I think Alexion did the right thing. They came out with the bad news as soon as they saw that the news were bad. Evidently they have themselves not yet fully analysed the data. If their ambition is - which they have stated - to present their data at the AHA-conference in November, they will have to keep their detailed data under wraps. A presentation at AHA seems to require that the data has not been disseminated beforehand.

Never a dull moment in biotech.

Erik



To: Madharry who wrote (293)8/5/2003 11:15:41 AM
From: keokalani'nui  Read Replies (2) | Respond to of 824
 
I think alxn is hoping whatever mortality benefit they are seeing will hold up at 180 days or will gain significance at that point; and that the reduction in perioperative AMI will correlate with reduced LT mortality. This data would be expected to be persuasive to FDA.