Re: How imminent is imminent - response from KERX
Thanks Greg,
Years ago I was told that companies got monthly data on enrollment and events, I don't know that it's the case today, but believe it may be. I also don't know how much delay's built into the data they receive, i.e. the status at the end of the month isn't reported until the 15th of the next month.
Knowing that information doesn't really tell them how well the drug is doing, as there is no knowledge of what group those who died came from, but it would permit them to estimate or modify the estimate of when a trial is expected to end. Perhaps they don't get that much information, but they must be getting something as months ago they revised the 4th quarter estimate to 1st quarter.
If when they report at brokerage conferences at the end of that they've not yet been told the final event is imminent, they might suggest that it may go into the second quarter, though certainly they have another full month to go. While looking at the models some posters here have done getting to March or beyond may be necessary, I have greater faith in the companies models which originally told them 4th quarter of last year should produce approvable data, and that going into the 1st quarter should mean the trial's gone better then it was originally modeled to go.
When the 360th event is announced, until top line data is announced there will be those who'll try to cast doubt on the data. If it were June that the 360th event occurred, there would still be those that would try to cast doubt.
Gary