Here is Martin's prompt reply...====>Hi (removed),It is a phase...

Here is Martin's prompt reply...

====>

Hi (removed),

It is a phase III or pivotal study for registration for both US and EU. As you can imagine trying to keep everyone happy on every detail across 17 countries and their respective health ministries is an enormous task and the team certainly has accomplished this with the CANVAS study for ovarian cancer vaccine.

CANVAS is an adequate and well designed study that is robustly controlled in a orphan indication. If the results are good and what we expect it will be then it will registered for marketing authorisation.

Hopes this helps as we are currently training 100 EU doctors in Prague today on use with CVac. Everyone is very excited.

Regards, Martin


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On 05/02/2012, at 1:38 PM, (removed) wrote:


Hi Martin

In this article link (http://www.pr.com/press-release/387492) it says "It is a phase II/III trial..." but before I queried this with the author (Kim Savage) the article originally said "It is a phase II trial..."

Below was her answer to my query.

Can you shed some light on this "technical regulatory registration issue" that Kim speaks of ?

Could it present any problem in the future ? ... perhaps US FDA will insist of a new phase III trial separate to the currently started phase III (seems it's not presently recognized in the US as a phase III".

Are there plans to resolve this problem ?

Many thanks
(removed)