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

To: Madharry who wrote (330)	8/12/2003 1:37:57 AM
From: Miljenko Zuanic	Respond to of 824

In all CCs for period from day they started Primo until data released they were talking about CABG-CPB non-valve population and with trial designee and endpoints selection that simulate results of the selected non-valve population from PIIb. There are two slides that explain everything, PIIb selected results and PRIMO endpoints. Nowhere is mentioned valve population. I can not paste here this two slides (do not know how), but can email if necessary. I am surprised how quickly everyone forgot what they were presenting and how story change structure, and this is at all not specific to ALXN. Miljenko

To: Madharry who wrote (330)	8/12/2003 11:34:05 AM
From: keokalani'nui	Read Replies (2) \| Respond to of 824

>>Perhaps someone could tell me: when the company sets up a phase III do they not have to file documents with the FDA as to the precise primary endpoints and secondary endpoints are prior to obtaining the results? Yes >>are these documents accessible by the public? no. fda doesn't want public pressure. sponsor doesn't want competitors (or shareholders) knowing. >>Because if what MZ is conjecturing that the CABG plus valve result was some minor secondary endpoint, which is how i interpret what he is saying, then what Bell said at the conference call was misleading to say the least. It was a secondary endpoint. Bell said as much. The degree to which it is minor depends on how statistician views it, perhaps how strong the data is on other endpoints, and the dgree to which fda feels like helping this drug along. I have never known Bell to be misleading. There is reason to believe this drug has activity and he believes it. The guy is/was a cardiologist. >>If MZ is correct in what he is implying then we have to look at that 25% vs. 30% and how does the FDA look at that- are we saying that 30% is statistically significant and 25% is not? Well sort of. The trial failed at 30%. I don't think the FDA is going to accept 25% in cabg -valve because that is where p=.05 is reached. The only way to imagine success is to draw the bubble around all patients who received drug--a population more representative of actual practice--that succeeded. That the fda might take that point of view assumes it is merciful, or at least not doctrinaire... Not to put words in his mouth, but MZ really keeps saying show me the data--no reason to trust self-interested vague assurances--that is all. I keep wondering if it matters how good rest of data is or is this going to be merely the first of two pivotal phase 3 trials? I read somewhere that for a single trial to be the basis of approval p has got to reach .00x--I doubt the larger population hit it that hard.