Multisystem Inflammatory Syndrome in Children (MIS-C), page-110

I just went back an had a look at the timeline on the last EAP (COVID ARDS) to compare to what we have for this EAP (MIS-C).

For the COVID ARDS EAP:
March to April - patients dosed (from results announcement)
6 April - ASX Announcement of FDA clearance
24 April - first submitted to clinicaltrials.gov
24 April - EAP results announced to ASX
29 April - first published on clinical trials.com (as EAP unavailable)

For MIS-P EAP:
? - No announce on FDA clearance
? - No announced patients dosed timeframe
29 June - first submitted to clinicaltrials.gov
2 July - first published on clinicaltrials.gov (as EAP available)

What can be inferred from this?:

MSB seem to have submitted just in time to meet the within 30 days submission requirement to clinicaltrials.gov for COVID ARDS EAP. First patient seems to have been dosed late March, so submission on 24th April is probably just under 30days. If the same were true for MIS-P, that could put the start of dosing at as early as early June.

MSB seem to have started dosing COVID ARDS EAP around a week before they announced FDA clearance on ASX. This has always seemed odd to me. Did they sit on the FDA clearance for a week without announcing? Or were the first ‘EAP’ patients dosed under some other type of authority while awaiting FDA EAP approval? Either way, it suggests that patients in MIS-P EAP could be dosed a week before we hear an announcement on FDA clearance.

Alternatively, is it possible that terms of original FDA clearance that allowed COVID ARDS EAP might be broad enough to encompass and allow for a COVID MIS-P EAP without further clearance?

Given what and when they announced on COVID ARDS EAP, it seems plausible to me that we could be either ~7 or ~30 days into a MIS-P EAP without having had an ASX announcement.