MSB $1 Party, page-775

SraGvHD- primary end point met. FDA want more data before approval. They will be given it in Q3.

CHF - unheard of benefits across the entire treatment group. Accelerated Approval could be granted any day, awaiting feedback.

Back pain pivotal 12 month trial commencing this year, off the back of average pain reduction being 50%.... unheard of again.

ARDS pivotal trial will commence once potency assays for SraGvHD are accepted. Likely to stop due efficacy within 6-9 months of commencement.

Crohns treatment so far has 100% remission in phase 2. Future trial likely to have 6 month end point since 6 months is used in definition of remission / severity.


Pivotal trial means final trial prior to approval.

Accelerated approval means it is approved now with conditions.

You can call that missing every shot all you like. The company has only applied for 1 approval so far, and its likely to come Q4/Q1... so missed 1 shot have reloaded and shooting again in Q3.

The other 4 are being loaded into the chambers...