MSB to dispute FDA finding in Type A meeting, page-2

Thank you @Zenox for starting this thread. Just so that we're clear everyone, PLEASE put on ignore any one who does not contribute to the discussion.

My thoughts are, that from an ethical standpoint, its very clear that Rem-L needs to be approved for this indication so that in the immediate interim, the cells can be used in the sickest of these kids with aGVHD.

Remember, these kids are ALREADY steroid-refractory, which means that the current SOC is NOT WORKING for them.

Hence I think, on that basis, the details for the study while being approved for use (via the Accelerated Approval Pathway) will be worked out in that meeting.

There is no reason for FDA to lead the team down such a positive path only to have it REJECT Rem-L. It doesn't make sense. They exist to help bring the best, safest, most efficacious treatment to the wider public, hence the need to data that will support Rem-L beyond a shadow of a doubt for this indication.

A lot of naysayers think that Rem-L is only for acute GVHD. It is not. There is way more it can be used for. Steroid-Refractory Acute GVHD is just one of them.