I did not say develop lux now. I said do not abandon it. I want to see the dose escalation data, which is NOT phase II. I am as acutely aware of the history and the current cash problems as anyone. I have outlined at least twice now possible financing routes to carry the work forward to significant PPS moving data.
I believe that in the TUSP dose expansion monotherapy trial we will be fortunate to see an ORR for r/rAML that failed flt3i in the 25% range. That is likely sufficient to get us into a fast track registrational trial, but I do not think it will have great impact on the PPS. On the other hand I believe that the TUSP + Venetoclax r/rAML cohort can generate an ORR of 40%+ (this is based on in vitro synergies). The combination arm is to run in parallel with the monotherapy arm for r/rAML, so I am hoping for the first combination readout to occur in 3rd quarter (possibly 4th quarter) of this year.
No one else is talking about this, so I believe that an ORR of 40%+ in r/rAML which has no approved therapies will be seen as a surprise breakthrough by the street. This is what will move the stock much higher. If I am correct, APTO needs to find enough cash (with minimal dilution) to get us into the late 2023 data readouts.
It is premature to focus on the costs of developing either drug to approval. We need to prove the value of the drugs which I believe lies in there use in combinations.
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