While approval has not fallen within our expected time frame,...

While approval has not fallen within our expected time frame, Alchemia is not aware of any outstanding items
that stand in the way of approval being granted. Multiple site inspections were completed successfully with
the most recent one completed in January this year. As a result, the Company expects there to be no further
procedural impediments required prior to approval. Alchemia anticipates the next communication from the
FDA to be the product approval itself.
While the overall process for fondaparinux approval has significantly exceeded Alchemia?s original
expectations, the Company is confident of the merit of its ANDA for fondaparinux and believes that the
extended review period simply reflects the current, long approval times for all generic drugs in the US.
Alchemia?s CEO, Dr Pete Smith, said ?We do not believe that there is anything that we could have done to
have expedited the process. We are grateful that all the key steps in the process are complete, in particular
the pre-approval inspection of the syringe fill plant. We remain confident of the approvability of our
fondaparinux application whilst recognizing that the ultimate timing remains in the hands of the FDA.?