osinod
Banned
ANX-530 and ANX-514 Timelines
ADVENTRX has entered into an agreement with a new contract manufacturer
to conduct process development and scale-up activities for both ANX-530 and
ANX- 514. Last week, the Company attended a pre-NDA meeting with the U.S.
Food and Drug Administration (FDA) to discuss its NDA submission for
ANX-530. The FDA requested additional information regarding the Company's
new manufacturer, and as a result, ADVENTRX anticipates the submission of
its NDA for ANX-530 will take place in the second quarter of 2009.
ADVENTRX also announced that it anticipates completing patient
enrollment in its registrational bioequivalence clinical study of ANX-514
in the first quarter of 2009. The Company expects to announce results from
this study in the second quarter of 2009. These changes will not affect the
Company's previously announced plans to submit an NDA for ANX-514 in the
third quarter of 2009.
MichBio: Driving Life Sciences Industry Growth
ADVENTRX has entered into an agreement with a new contract manufacturer
to conduct process development and scale-up activities for both ANX-530 and
ANX- 514. Last week, the Company attended a pre-NDA meeting with the U.S.
Food and Drug Administration (FDA) to discuss its NDA submission for
ANX-530. The FDA requested additional information regarding the Company's
new manufacturer, and as a result, ADVENTRX anticipates the submission of
its NDA for ANX-530 will take place in the second quarter of 2009.
ADVENTRX also announced that it anticipates completing patient
enrollment in its registrational bioequivalence clinical study of ANX-514
in the first quarter of 2009. The Company expects to announce results from
this study in the second quarter of 2009. These changes will not affect the
Company's previously announced plans to submit an NDA for ANX-514 in the
third quarter of 2009.
MichBio: Driving Life Sciences Industry Growth