That company you speak of @RickyH has a few differences in...

That company you speak of @RickyH has a few differences in comparison to our BLA for Ryoncil treatment of aGVHD ... here are a couple of examples;

1. Their product wasn't targeting an unmet medical need (i.e. antibiotics can clear up what they are treating)

2. Their product wasn't saving lives, let alone the lives of children under 12; and

3. It took that company at least 8 months to get a follow up meeting with the FDA - MSB had one within 30 days as they advised the market they would so a little different approach.

Hard to compare the two really but I get your concerns with the FDA; I had several reservations in the lead up to the original decision and the main one is they are a law unto themselves




COVID-19 numbers are bordering on 3,000 with 14 states yet to report but I will do the usual reporting later when numbers have been finalised for the day ... vaccine rollout is also way behind schedule as well - Biden says instead of the anticipated 20 million target by the end of the year they have only dosed a couple of million ....

disallowed/world/north-america/vacc...-vowing-to-accelerate-it-20201230-p56qs9.html