he said pre-i-spy and i-spy-2 because both are being run as you acknowledge. pre spy is phase 1 the other spy is phase 2. phase 1 and phase 2 doesn't run concurrently. pre-spy is dose escalation. i assume 3 doses 1 month each. it will be first, prior to the phase2, but it will be fast. 3 months of dosing. almost instant transition into phase 2. that near instant transition is a SPY thing - one of its most attractive features. same thing happens when graduating from phase 2 to phase 3.
the graduation is dependent upon a bayesian calculation requiring "powering", similar to when chasing a p-value. they have a very specific value that the calculation must "achieve" for the graduation. 85% probability of success in the following phase. its not a meeting where a bunch of people say "hey we think this looks good lets move it on." its a very specific calculation that is updated in real time and then a buzzer goes off when the threshold is met.
phase 1 bayesian is based on toxicity.
phase 2 is based on efficacy of course.
phase 2 has a set in stone minimum of 20 patients before graduation to phase 3 is possible, maximum 120. if leron / ici performs similar to the retro data it will graduate a lot closer to 20 than 120. less than 60. less than 40 i think is fair to say. i'm always conservative so i don;t wanna set myself and others up for disappointment and say something weird like "well of course at 20 its done!". virtually nothing in biotech ever happens when you think it will happen.
https://www.quantumleaphealth.org/wp-content/...Barker.pdf
the graduation is dependent upon a bayesian calculation requiring "powering", similar to when chasing a p-value. they have a very specific value that the calculation must "achieve" for the graduation. 85% probability of success in the following phase. its not a meeting where a bunch of people say "hey we think this looks good lets move it on." its a very specific calculation that is updated in real time and then a buzzer goes off when the threshold is met.
phase 1 bayesian is based on toxicity.
phase 2 is based on efficacy of course.
phase 2 has a set in stone minimum of 20 patients before graduation to phase 3 is possible, maximum 120. if leron / ici performs similar to the retro data it will graduate a lot closer to 20 than 120. less than 60. less than 40 i think is fair to say. i'm always conservative so i don;t wanna set myself and others up for disappointment and say something weird like "well of course at 20 its done!". virtually nothing in biotech ever happens when you think it will happen.
https://www.quantumleaphealth.org/wp-content/...Barker.pdf
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