Yes. But I think soft lock can be different things in different cases.
You could have all your data in; nothing missing at all.
And you soft lock it. And then you do a final audit, before hard locking. Just a last QC check.
I imagine that is a common process. To the extent that it is often not mentioned at all. Just a routine part of final scrubbing.
But, we clearly have a small amount of stuff still outstanding.
I am not in any way suggesting it's the company dragging heels.
I'm quite sure they want to get over the line as much as shareholders want them to.
The questions are (for me at least):-
What is still outstanding? Is it all the data from the last few sites that still needs to be signed off? Or is it just the IDH status of a few dozen subjects from wherever.
Can you (sensibly) move towards topline announcement, if some stuff is still missing?
What is the anticipated duration of delay before everything is signed off and to hand?
And I'm sure the company is juggling with these issues right now.
It must be really frustrating if you need an in-person visit to check a patient file, and that site is rigidly sticking to a Covid no access policy.
And (somewhat to myself), I ask whether there is some sort of deliberate delaying going on from a third party.
If this was a Covid vaccine candidate in trial, nothing would be allowed to get in the way.
So I just think they need to keep us informed in these last few weeks by regular detailed updates, as the current situation requires.
The last two times they gave us an update (including yesterday's 10-Q), the market was quite happy and hopped up a bit.
Final hard datalock is the milestone. And the culmination of a decade's work. The CRO will have completed its task. Then the company management can take a brief breather while the stats crunch the numbers for a couple of weeks.
I just don't want them to move to hard data lock, if there is important data still outstanding. It might come back to bite them if they do.
(If it's only IDH mutation, then I don't think it's mission critical.)
JMO.
