Replies to post #95100 on Biotech Values

[DewDiligence]

…belatacept was compared to cylcosporine not to tacrolimus, which is used more often, considered more potent and does not harm kidney function as much.

In the “Belatacept Conversion Trial in Renal Transplantation” (http://clinicaltrials.gov/ct2/show/NCT00402168 ), the control arm was either (continued) cyclosporine or (continued) tacrolimus. However, this open-label study was merely a supporting actor in the belatacept BLA.

[DewDiligence]

BMY responded to the FDA’s Belatacept CRL, but the FDA told BMY a decision on the BLA is on hold until BMY brings manufacturing at its Puerto Rico plant into compliance. This will delay a decision on the Belatacept BLA until at least 2Q11. (Source: BMY’s 3Q10 CC)