85% chr for chronic phase and significance

Disclosure: I am not a Financial Advisor and I am not an Oncologist. DYOR.

I have read through the FDA report.

Obviously there are some parameters around the trial, which, based on the report, Chemgenex failed to adhere too. I guess this was always the big risk going it alone with the trials rather than partnering earlier on with a more experienced Pharma.

Im also disappointed with the discussion around a commercial T315i test. I was under the impression that after the conference call a couple of months ago Dr Cortes indicated there was such a test. Was it not a commercial test? Clearly early detection is the key to successful treatment.

Greg had better have a good explanation for the above two points during the ODAC meeting, Im sure he will be prepared.

Now looking at the results. And comparing them to previous news releases there re some obvious discrepancies. Perhaps the true explanation will not be provided by Chemgenex before the rescheduled ODAC meeting when it is rescheduled, it probably not a good idea to publicly rebut the FDA in the media before the ODAC meeting.

Table 7 is the most interesting table for me. Especially when compared with Chemgenexs results.

I'm a little confused as to why the 85% Complete Hematologic Response (CHR) for Chronic Phase patients isn't noted in table 7 of the FDA report, it just has NA.

Surely these Chronic Phase Patients with a CHR would have deteriorated and perhaps eventually die if it was not for Omapro. Less tha 7% of CP patients on Omapro died (and it's not clear if this was due to treatment, CML or something else). To me this is seems an acceptable risk/benefit ratio.

Section 2 Paragraph 3 states: The primary efficacy endpoint for Chronic Phase CP patients was major cytogenetic response (MCyR), consisting of complete cytogenetic response (CCyR) and partial cytogenetic response (PCyR), or CHR (Complete Hematological Response).

Under Section 6.8 it states that for Chronic Phase that only peripheral Hematologic results are necessary. I understand this to be CHR.

Thoughts Anyone?