Ann: COVID-19/GVHD Update, Quarterly Report and Appendix 4C, page-162

It's three of the key reasons I was able to temper my disappointment with the "delay" (which is only a perception that we have, when by SI's own words, it's right in time). It's an extra month or more for MSB and Lonza to manufacture product, it ensures we get those 300 patients just in case anyone has any doubts about results, and it puts us well past the Adcom meeting date, ideally, giving a very clear indication as to the view on approval of Ryoncil's BLA prior to the readout on the ARDS trials.

All of that, particularly the stock issue, will make the arguments for immediate approval that much more compelling. Product on the shelves, in bulk, ready to ship. That can only further burnish MSB's case and the FDA's review of its use for COVID ARDS. Why wait?

I would LOVE to be a fly on the wall in the MSB boardroom, and to understand the way they are viewing the risks and rewards here, their thought process on the trials, discussions with the FDA, timing of announcements, prioritization of projects, partnership considerations, etc., etc. They seem supremely confident in all of their moves up till now, just seriously cool customers. We sit and whinge and moan about lack of updates, but they are just quietly--and professionally--getting on with things. Just so impressive to me, an interested outsider.

I hope someday someone writes a book about these days at MSB and gives us some real insight into the reasoning on the decisions they have made. Would be fascinating.