I may be wrong, but I believe the company is still involved with something that isn't completely in their control, namely the approval of their SAP by all four regulators. Once that's done I believe they're fully in control of all else that occurs in unblinding and reporting on the trial.
I suspect the FDA has a fixed number of days to comment on the proposed SAP, lets say 60 days for discussion purposes. If they answer and want a change made on day 60, once the change is made and submitted, the clock goes back to 60 days for review. In a similar situation I've seen the FDA stall approval of drugs for well over a year, but ultimately the drug was approved.
To me, one of the worst things about the way the regulators operate is that they can question anything, at any time. As an example, lets say the SAP was made up of 50 sections and a change was requested in the 10th section. When that section was submitted and accepted they could comment on another section they'd previously accepted, perhaps multiple times. The delay can come in completely unrelated areas that previously were believed to be accepted. This simply shouldn't be permitted, but it is.
If it were up to me, after an initial review the regulators should sit down with the and either agree to the changes as modified, or actually make further changes where all are in agreement. Instead of taking many months it would take a few hours. Until such dynamic actions are agreed to by the FDA and other regulators, the time to acceptance of documents like the SAP is unpredictable. Hopefully they're about to be past the threshold where the regulators can comment, but until that occurs, nothing else can proceed.
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