Just finished listening to the web cast…. I thought we were...

Just finished listening to the web cast….

I thought we were bushwhacked 3 years ago. Now i know it ( (despite the assay improvement, as all therapies move towards improvement) . FDA moving goalposts. Not the 1st time.

Regardless, reading between what wasn’t said, getting Ryoncil over the line involves leaving FDA no avenues for them to be able to fault.

I can see compassionate use for Kids getting leveraged as pointed out and unfortunately , in this context, warranted.

MSB are 3 years further down their journey. The cells work. Ryoncil in adults have statistically reached survival levels that no other drug can as their benefits have exhausted. It has to be black and white with an urgent need. The trial design will further squeeze FDA into a corner where they won’t have any room to fault.

Re timing, Siviu , mentioned 40 sites, not a large trial as far as numbers and a 90 day end point. 12-18 months.
Funding will be interesting but Silviu seems to have that sorted already.

I,see this knockback although as a tough day to take, it is just a delay.