Examples of BLA Filing in a sentence
Therefore, until the Initial Regulatory Filing is made (the "BLA Filing Date"), the Company shall be primarily responsible for conducting the clinical studies and all other regulatory matters, manufacturing matters and/or pre-clinical studies necessary to support, prepare and file the Initial Regulatory Filing until the BLA Filing Date, and the Company shall use all commercially reasonable efforts necessary to make the Initial Regulatory Filing.
A subsequent FPA008 + “Antibody C” in a first Indication would not trigger the *** milestone payment for BLA Filing in US, but FPA008 + “Antibody C” in a second Indication would trigger the *** milestone payment, even though FPA008 + “Antibody C” in its first Indication had not previously triggered a milestone payment for BLA Filing in US.
As soon as practicable after the BLA Filing Date, and consistent with the transition plan adopted by the PDC and contained in the initial Clinical Development Plan, the Company shall transition such clinical and other studies ongoing with respect to the Products which have been identified in such Clinical Development Plan as being transferred to ERS in such transition plan from the Company's sole control to the control of the Party(ies) set forth in the initial Clinical Development Plan.
Results with age breakdown Route to Registration Clear for Heplisav; Two Phase III Studies Ongoing and BLA Filing Expected Q3:2011 Bouncing back from a clinical hold debacle, Dynavax has a clear path to registration with Heplisav.
TNT Express and FedEx have agreed that the composition of the Supervisory Board will be such that all individuals are sufficiently qualified and have sufficient experience and background that they can be reasonably expected to contribute to the future growth of TNT Express and the realisation of its strategy as a part of the Combination.