I wonder if this situation has anything to do with it.

No FDA Director yet. 

Acting Director criticized by anti-opioid community for letting that go through.

Apparent clamp down on several other drug approvals in response...

Etc.

Could any of that cause a delay to get into clinicaltrials.gov once Canada has already approved a trial?

Would our good safety profile to date protect us from such delays, or could FDA be seeking additional info, or just not prioritizing us somehow?

Still it would seem that a covid trial would get priority.

I guess the only thing we really know is that we don't know.

Won't be the first biotech to fall behind schedule/ take longer than investors have wanted. At least the news on the scientific side still seems mainly good so far.

https://endpts.com/fda-delays-kadmons-priority-review-as-apparent-clampdown-continues/