The following might bring some light to the discussion about phase 3 trials.
From the investor update announcement on the 13/09/2010:
CVac? registration study in Europe. The Company
is already engaged in preparations for its
registration study for CVac?. In the first half of next
year it aims to secure regulatory authorisation for
the trial and then initiate the Phase III Trial. The first
component of this is to have the EU approve the
license of the manufacture of CVac?, and then the
Company will be able to move forward into patient
recruitment for the trial.
Commencement of the Phase III trial in Europe will
be a major point in CVac??s development, as from
this point on trials will be run concurrently by the
FDA and in Europe. The goal will be to achieve a
larger data outcome in a shorter period of time.
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- spoke to martin rogers yesterday - excellent
spoke to martin rogers yesterday - excellent , page-9
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