Sam
>>Why a "truly binary event" as opposed to a normal binary event? >>
Because I feel that sometimes important events are labelled as binary, even if they in reality are not. But if Stellar 3 meets it primary endpoint it will IMHO have a substantial positive effect on the share price.
>>What makes this event so significant as compared to other milestones like Stellar 4 data and lung cancer study data due later in 2005?>>
Becasue it is the first one from which results to be known. I don't think there is much reason to believe that if Stellar 3 fails one of the other one might turn out positive. On the other hand, if Stellar 3 is positive, the results from the other two will not matter. They will only have to score once.
>>What exactly does it mean that "[t]he sought endpoint is a 30 percent improvement in median survival time." Does this imply that the FDA approves IFF they reach this precise endpoint?>>
Yes correct, there is a SPA spelling out what is required for approval.
>> Why 30% median, instead of, say, 25% mean? >>
Medium and not mean seems to be the standard measurement used in case like this. It is a way of cutting away the effect of the tails, I suppose. And it is much more practical. If the mean is used, one would have to wait much, much longer until it is possible to calculate the results.
The figure 30 % is needed (if I have understood this correctly) to reach statistical significance. I might be wrong there. Maybe Biocruncher can explain.
There might also (speculation on my part) exist a need to not only reach a statistical benefit, but also something that is clinically meaningful. The NSCLC PS2 population recruited into this trial seems in similar trials to have had a MST of say 3 - 5 month when dosed with the standard combo treatment of carboplatin and paclitaxel. Adding 10 or 15 % to the survival time will not bring much of an improvement when converted into days. This fact might be reflected in the 30 % requirement, which on the surface looks rather high.
>>What about other jurisdictions? Will Canada, Europe, Asia (ex Japan) and Latin America likely follow the lead of the FDA?>>
No, I don't think they care at all about FDA's opinions, but they may very well evaluate the results in a similar way.
>>As a biotech investor, how do you regard the attractiveness of the CC writing strategy: B CTIC / S March CC?>>
I am not into options at all and have no opinon on that. I just wanted to point out a possible reason for the high premium.
Erik |
