Alchemia Limited

Alchemia Announces Successful Pre-IND Meeting With the US FDA

Published in Cancer Weekly, February 12th, 2008

Australian drug developer, Alchemia Limited (ASX:ACL), announced agreement on the HA-irinotecan clinical development program, following a pre-investigational new drug (pre-IND) meeting with the United States (US) Food & Drug Administration (FDA).

Chief Executive, Dr Peter Smith, said that the company was delighted with the outcome of the discussions. "Alchemia now has a very clear path to market for HA-irinotecan following on from the highly successful Phase II clinical trial completed last year. During our pre-IND meeting with the FDA, the agency agreed on the proposed pivotal trial design and we will file our IND application to begin the trial in the very near future....

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Source: Cancer Weekly (2008-02-12)

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