So we all know the trial finished around mid-October. At what point does the company get the data? Does an independent Data Monitoring Committee have to review it first, then pass it to the company? Or do they get the data immediately after the trial ends?
I honestly just don't know. And maybe it's different based on different trial designs.
I would think the first goal after receiving the data would be to crunch the numbers and determine if at least the primary endpoint was met. Next, you'd determine if each secondary endpoint was met, of which they have quite a few in this trial. If the primary endpoint was not met, this second step would be vital to any press release. But either way, you'd want to know both before releasing the news.
I'm not attempting to speculate at all on the timing of the Z944 news today, etc. Just wondering if we can rightly assume that 2 weeks following the completion of the trial, the company knows whether it's a success or not... Or, if they are handed the data only after it's been reviewed by a DMC... Or, if an independent group does all the number-crunching for the company, determining success on all primary and secondary endpoints, and then hands that info over, along with all the raw data for the company to analyze at its own pace.
Does anyone know the answer to this question?
More curiosity than anything else, as I've sat through several of these data releases with various companies, including ACAD, and never known exactly when the company knows or doesn't know.
For the record, ACAD released their positive results exactly when analysts predicted. CLSN on the other hand, which I also sat through, waited until the last possible day they had forecast, canceling a conference in the meantime (and lying about the reason), to release their negative data. I know ZLCS hasn't forecast a date, so that's not an issue.
Just wondering where analysts get this idea that it always takes 4-6 weeks to figure this stuff out.
The company has the data just as soon as they can be collected and verified from the sites. DMC isn't involved much at this stage. They're more about interim safety and efficacy, or company requests for info, or changes in trial design (as a result, usually, of slow enrollment or slow attrition in the case of trials with overall survival as an endpoint).
Time to crunch the data varies, but the 4-6 weeks estimate is a good average. Bottom line, the expected timing of PII results announcements are fair. Mid to late November.
Thanks, rul! That helps. So we can assume the company has the data now and is putting the figures together. Maybe even they have a rough idea of whether it's met the primary endpoint. Seems like the best time to release, if at all possible, would be the week of November 11th, before the partnering conference.