MSB to dispute FDA finding in Type A meeting, page-48

So the plan is to persuade the FDA to reverse their decision and approve immediately whilst waiting for a secondary trial on adults.

They won't be presenting new evidence at this stage.

I think it would be highly unlikely that the FDA will overturn it's decision. The FDA are well aware they could have given approval but with conditions of a follow up trial in adults. They chose not to offer this path, I don't MSB expects to reverse their decision without new information.

In my mind the next point they will have further evidence to support their case will be the completion of the ARDS trial which the 45% readout has pushed back to early Nov. Otherwise we are looking at next year before we have the new trial data the FDA require.

Both SI and FG were trying to show a stiff upper lip, but you could hear they were very flat - almost in shock.

I still believe in the long term this will be approved, but the risk level of this company has risen dramatically. This was the lay down misere. What sort of a roller-coaster ride are on with CLBP and CHF? A disappointment on either of the next 3 big announcements will smack us back into the stone-age.

Difficult and dangerous times for us holders but I still believe in the long term this will just be a setback, but it's going to be a white knuckle ride.