September 27, 2016 12:06pm

For LentiGlobin drug product in the treatment of patients with transfusion-dependent beta-thalassemia (TDT).

 


 

To be accepted for PRIME, a therapy must demonstrate potential to benefit patients with unmet medical need through early clinical data or nonclinical data. Access to the PRIME initiative complements bluebird’s ongoing participation in the EMA’s Adaptive Pathways Pilot program, which also aims to expedite patient access to therapies with the potential to treat serious conditions with unmet need.

 

The Bottom Line: The PRIME initiative provides enhanced support and increased interaction to companies, with the goal of optimizing development plans and speeding regulatory evaluations to potentially bring innovative medicines to patients more quickly.

BLUE closed at $$71.27 and opened at $71.84 and is UP +$0.80 to $72.07 – let it settle. News and volume facilitates timing to a SELL signal …