If possible for an expedited low cost solution I am all for it. Seems to be some pathways are being refined for the strategy. This is why IMO strategy was a flop, not because of personalities.
1. Scale back to one R/R AML trial, go for approval and deal. Dacogen has existing relationship and FTO expression. Venetoclax is competitive space and cardiotoxicity. Stick with what is known?
2. Cardio protect, and FTO biomarker 2 in one trial. Need to avoid mBC recruitment issues for low patient population. Increasing Sites numbers might not be cost effective. Small P2 Australian population and scale up overseas.
3. Validate FTO assay post approval, thats why Dacogen might be better be useful compared to Venetoclax. Obtain CDx post approval. This will be fast and effective and let COH continue their work in the interim. Do we need a standalone FTO solid tumour trial?
thoughts only, looking forward to some clarity on the strategy shortly.
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