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/