Ann: Update on Scheduled FDA Advisory Committee Meeting, page-110

Why would "insiders" (conspiracy crap) dump, even if the FDA were to tell MSB to come back with a proper job?

"Insiders" know that aGvHD is small fry to MSB. Before end September we should know about 2 blockbusters (CHF and CLBP) and 1 unmeasurable P3 in Covid-ARDS.

"Insiders" would more likely be buying from the pants-wet brigade today, looking to the big ones.

The briefing papers are nothing more than the FDA making it very public that they don't accept anything but the best. They put MSB on public notice that they gotta be good. But they highlighted the hoops to be jumped through. Gave advance notice, allowing MSB, if they could, to get answers ready. Just normal process. It must look right. Beyond reproach.

If the FDA had already decided this application was a fail they'd have made it plain to MSB. And MSB would not have needed to be told. The FDA knows very well that children are dying from this condition. They won't accept any old application. But they want this to work. Rejection won't be based on outdated data. They have to decisively counteract the relentless propaganda of well-funded "competitors" for Ryoncil. They can't make the argument. They must ask others to do so. That is what they have done.

The FDA has invited MSB to respond to all possible objections. That's all. Just an invitation. Let's hear what the response is.