I do believe you are right. They are telling us that all the subject clinical data has been collected, all queries resolved, basically all scrubbed and ready, and now resides in a locked state with the CRO. That should include everything that pertains to endpoints, and also the record of SAE's (which hopefully will be a very good record rather than anything of any concern). So the company (and hopefully nobody else!) will have cause to access that database until full unblind.
I get the feeling that they've basically achieved what they previously described as soft lock, but also that they've decided that it's not worth accessing the data on a soft lock basis. So they are just leaving it tucked away and not touching it.
And they are just shy of full 5yr data for the last few patients.
Basically, all that appears to be left outstanding is patient biomarkers.
And the one we know they are trying to collect is IDH status. I don't think they are going to be able to gather this 100%, because I suspect that there may be no available tumor tissue for many of the subjects, particularly for those who were in the early years of the trial and are now deceased. In the last few years, screening for IDH status has been standard practice for most all GBM patients anyway, so for some later entrants, they may already have it. The way I read the PR, it sounds like they may even be going back to some currently living patients to gather fresh samples, but I don't really know how they would achieve this (liquid biopsy?)or even if it is biologically possible. I think there are several different assay techniques to ascertain IDH status, so they may be using more than one in the case of some subjects, to get a confirmed result wherever possible.
The question that comes to mind is; why didn't they collect this as they went along, as part of patient screening. Well they perhaps couldn't do it for early patients due to the role of IDH mutation in GBM only being discovered in about 2009. But IDH status may have been routinely gathered for some of the late entrants, so they will already have some of it.
I tend to think this is a regulator request made in just the last year, which has necessitated them having to try and retrospectively gather this information for as many subjects as they can. Bit of a pain really, because it is unlikely to alter trial outcome in any substantive way, but it could be seen as academically useful. I don't think they are chasing down any other biomarkers, except possibly EGFR amplification. Which again isn't of much significance in the scheme of things.
I really don't think they intend or are even able to identify the different genomic transcriptions, such as pro-neural, mesenchymal, classical. And these latter classifications are a very moveable feast anyway, due to intra-tumoral heterogeneity and shift over time.
So on IDH, they will try and get a status confirm wherever possible, using maybe a couple of different commercial labs, but they will just go as far as they reasonably can, rather than chase forever.
I can't see any other unexpected hold-up, so I'll stick my neck out and say we will get confirmation by PR of full datalock, not later than the mid-point of August. And I do think they will publically confirm it.
JMO.
