MSB to dispute FDA finding in Type A meeting, page-228

Absolutely agree.

My only point was that MSB is going to be bringing in every big gun they can to make clear to the FDA that they need to be fair and reasonable on this.

It's normal to NOT involve the higher up connections initially, letting the application go through the system normally and giving the agency the chance to do their job.

But when roadblocks are hit (as they have been here), and particularly where the decision seems to defy logic and common sense (as this one does, in some ways), that's when you need to start hitting the phones and raising your voice.

MSB is offering a very rational "settlement" - conditional approval of pediatric treatment, with commitment to a full RCT for adult AGVHD. With the right push and the right people high up in the FDA looking at this, hopefully a compromise can be brokered, in spite of the noise and other dumpster fires that are raging.