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Event details

Viralytics - US FDA meeting

Description:
At the pre-IND meeting, the FDA will review a dossier that summarises Viralytics proposed
Phase II clinical trial and its supporting data in the form of non-clinical testing in vitro (cells) and
in vivo (animals) studies, the manufacturing and process controls that will be used to produce the
clinical batch of CAVATAKTM and the Phase I clinical data accumulated to date.

Viralytics’ managing director Mr Bryan Dulhunty said “Following the pre-IND meeting, and
providing any additional information or data requested by the FDA at the pre-IND meeting,
Viralytics plans to complete and lodge an IND application to conduct its international Phase II
melanoma study centred in the USA. The IND application once lodged is deemed authorised
with 30 days of the application if the FDA raises no further comments or questions. 
Location:
USA FDA 
Starts on:
22/06/2010 08:02
Created by:
admin

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