MSB Trading - Aug 2020 on, page-1109

Correct. FDA presents the gaps between their ideal world and reality. And then asks a panel of experts to deliberate/discuss to find a better solution as well as any show stoppers. This way, FDA has covered all bases (and has some cover if they screw up). They do the final risk assessments.

Ppl have to remember, this is not a blockbuster drug for a population wide indication to reduce a couple of points in cholesterol for patients who will take the drug every day for life and may have a 10% less chance of a stroke. This treatment is for a very small population who will very likely die and who have run out of all possible approved treatments. They also happen to be some of the most vulnerable in our society (U12) and this drug has less side effects than any treatment currently approved in the treatment cascade for their disease.

If you want to see what FDA really think about the safety, efficacy and manufacturing processes of this drug, just look at their actions for Rem-L in recent months:
1. approved EAP for ARDS
2. subsequently approved 300 patient phase 3 trial for ARDS
3. approved EAP for MIS-C in children

So FDA have grave concerns about the MOA and the ability for MSB to manufacture to a consistent quality parameters (which they don't believe are linked to any clinical outcomes) but thought they would just let Rem-L loose on a whole bunch of new, vulnerable patients? That makes no sense and is inconsistent with the market freak out today.