MSB to dispute FDA finding in Type A meeting, page-230

Thanks again@stockrock

I stand corrected on their approach to Accelerated Approval - and I agree that will be a big uphill battle being a totally different process

I’ve listened to the Webcast again - and Fred Grossman @ approx 21:15 in says that after consulting with adult GVHD experts, their approach to the subsequent study for adult GVHD “... taking advantage of our existing data and what we know about Rem-L which has very substantial efficacy and safety particularly around survival and durability of response ... we plan to discuss this with the FDA....”

Also @ approx 13:45 in SI mentions that apart from meeting the primary end points in the phase 3 trial (28 Day ORR), the phase 3 trial also “showed a very good survival” in patients

Was survival specifically measured in the phase 3 trial?

Beyond those two snippets I cant find any specific reference to survival in the Webcast

They are also going quite hard on the fact that physicians (and Joanne Kurtzberg specifically) are dead set (my words) against an RCT in paediatric patients.

How much weight do you think that will add to the likelihood of an Accelerated Approval ?

Thanks in advance