bollocks to you fda, page-4

he obv missed the extra 2...I'm guessing should have read 22 mar?

Before reading the below I would like to preface that I think approval will be granted to CXS but it will not be a unanimous vote.

This is still a huge risk and you should not get into it unless you want to experience a few sleepless nights.

My gut feel is if there will be 14 members on the committee (could vary between 13-15) then I'm expecting 10 / 4 split for approval.


Also prior to this vote, I suspect that CXS will update the trial pack to the FDA 5 days prior. Comments from CXS's operational manager leads me to this possibility:

'Chemgenex chief financial officer and chief
operational officer Dr James Campbell said that one of
the issues was that the FDA was only addressing
data in the submission of mid last year.'

The latest data (on Dec 2009) for 202 included 81 patients. There are improvements between the latest data and the previously submitted data results esp in the major cytogenic results. Including the snow delay they will have a further 2.5 months of further results on top of that.

Also since that time CXS should be able to provide further information re confirmation of lab results and techniques used to identify T315I mutation.

At the time when FDA's questions were first published Greg seemed very confident that the lab tests conducted will stand up to FDA scruitiny and they will be directly addressing these concerns in their presentation on the 22 Mar.

Let's hope that Greg's comments re We think our data will stand up beautifully hold true and approval is given.


Some key results from Dec 2009 trial 202 update:

Data were presented from 81 CML patients: 49 in chronic phase, 17 in accelerated phase and 15 in blast phase. Highlights of the data were:

Complete hematologic responses (CHR) in 86% of chronic phase patients, median response duration 9 months

Total cytogenetic response rate of 41% in chronic phase patients, with major cytogenetic response (MCyR) rate of 27%

Overall hematologic responses in 35% of accelerated phase patients (median duration 7 months)

Overall hematologic responses in 47% of blast phase patients (median duration 2 months)

Investigators reported that omacetaxine is safe for self-administration, is well tolerated, and that reversible and manageable myelosuppression is the most common side effect