Tumor response through a biological marker, efficacy, and then PFS in that order. M6A level change and how it correlates with responses. Biological marker is taken instantly, efficacy established after the first few courses of treatment, and PFS a more long-term marker.
Cardioprotection through typical measures as well as VO2PEAK most importantly. The obvious comparisons to make are cohorts receiving dexrazoxane as well as VO2PEAK cohorts receiving cardiotoxic regimens. Because VO2PEAK is very sensitive, it can measure cardiac damage within 6 months of dosing and give meaningful, comparable data.
The following criteria is required for excellent CPACS.
From what I can tell, RAC are gunning for a geographical licensing agreement for China, Japan, and South Korea where anthracycline dosing ranges from 12-14 million each year. Doxorubicin ranks number 1 as the most essential drug globally by almost 950 oncologists in 82 countries. The other anthracyclines to make the list of 100 compounds are Epirubicin (30), Danorubicin (64), Pegylated liposomal Doxorubicin (78), and Idarubicin (88). It's quite hard to find reliable information on frequency of dosing for Dox relate to its peers, but if oncologists see it as the most essential anti-cancer agent on the planet, then we can assume it's used frequently.
I suspect that this is it, big man. No more hiding. Information will be rapidly shared down the line to strike a geographical licensing agreement for the use of Bisantrene in these countries off-label. JDP and I speak quite regularly, and he certainly knows a lot more than I do regarding these deals, so I would pay attention to him.
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