registrational

The suggested minimum registrational contribution is 10 UK Pounds Sterling or 20.00 US Dollars.

DOCUMENTATION: COMCall Version 3.0 by Clive Jones 1992

While Isis Pharma will be responsible for the global development of ISIS-SMNRx through the completion of phase II/III registrational studies, with input from Biogen, the latter will take over global development, regulatory and commercialization responsibilities if it decides to exercise its option.

unknown title 2012

The registrational trial is an open-label, multicenter, single arm efficacy and safety study in patients with relapsed or refractory PTCL, who have failed at least one prior systemic therapy.

unknown title 2011

Belinostat is currently in a registrational, pivotal trial, under an SPA, as monotherapy for relapsed and refractory PTCL, an indication which has been granted Orphan Drug and Fast Track designation by the FDA.

unknown title 2011

Belinostat is currently in a registrational trial, the BELIEF Study, under a SPA, as monotherapy for relapsed or refractory PTCL, an indication for which it has been granted Orphan Drug and Fast Track designations by the FDA.

unknown title 2011

The applications include data from three registrational studies, ADVANCE, ILLUMINATE and REALIZE, which evaluated telaprevir in people with hepatitis C who were new to treatment as well as those who did not achieve a viral cure after treatment with currently available medicines.

unknown title 2011

Consistent with the Company's global regulatory strategy, and the importance of the Chinese market within that strategy, Celsion is continuing to enroll patients in the HEAT Study in order to randomize at least 200 patients in China, a requirement for registrational filing in that country.

unknown title 2011

At this time, a Company sponsored Phase 3 registrational study of ZYBRESTAT in patients with anaplastic thyroid cancer ATC funded by Company financial resources is not feasible.

unknown title 2011

At 600 patients, the HEAT Study has already enrolled a sufficient number of patients to support registrational filings in two other important markets for ThermoDox® in Asia, South Korea and Taiwan.

unknown title 2011

"We are pleased to announce that belinostat's pivotal, registrational trial in relapsed/refractory PTCL has achieved its target enrollment," said Rajesh C.

unknown title 2011