Good point. I have not read anyone else who understands its significance.
" The criteria is difficult and for this trial, the data exploration is very technical. They are using highly sophisticated mapping tools. "
IMO the short trial and small number of patients is deceptive. The clinical trial is for the purpose of doing virtually every known test to elucidate Kevetrin's exact mechanism of action. Again IMO, Bertolino formulated this trial after meeting with potential big Pharma representatives. Evidently it is important to big Pharma not only to have the first approved P53 modulating drug but also know its exact MOA. Could this potentially lead to another patent? Perhaps other posters have some insight. I could not guess about the patent, but it is a slow expensive way to determine the MOA in a drug which demonstrated efficacy and safety in its FDA stage 1 trial. I can find no evidence that the FDA ordered this trial. They seemed ready to move to the to the larger FDA stage 2 trial with single and combination arms of study.
"Modulation of the p53 pathway to further inform Kevetrin’s mechanism of action (MOA) is being measured via various RNA and protein biomarkers. Endpoints will include safety, efficacy (based on RECIST criteria) and pharmacodynamics. Running in parallel, the Company continues to make substantial progress in developing Kevetrin as an oral formulation. Preliminary bioavailability and other laboratory studies are encouraging and support its potential as an oral formulation. Currently there are no approved p53-modulating drugs, much less in pill form. An oral formulation of Kevetrin one day could position the drug candidate as a go-to cancer treatment."
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