Timeline to data.
Here is what i am contemplating.
December January enrollment leaks indicates perhaps 10 per month. That is always something you are guessing at but let's just call it that. 30 enrolled by end january and 40 by the end of february. trial document says 30/30 at 350/700mg. dsmb may have greenlighted 700mg enrollment after 20 enrolled. either way...
if they are truly going to share interim data, and i expect they likely will be, based upon how small biotechs generally operate, how cydy has done things b4, and i guess a hint to that effect from hoffman?... then i would expect them to wait until they have pd-1 levels from both 350 and 700mg patients. and i'd expect the minimum breakdown to be 20/10 or 30/10 (or 20/20). i think they might not consider sharing until they have data from 30 or 40 patients so that they can show the superiority at 700mg. seems silly not to wait until you have that, as 700mg will ultimately be the dose that they pursue and which the fda has always supported.
also i assume that 4 week PD-1 data is the bare minimum, but 8 weeks might make more sense. i haven't looked back at their data from tnbc lately, but i think the max pd-1 levels were in a large-ish range? 4 to 12 weeks? anyway 8 weeks from end february (40 enrolled?) is roughly end of april.
i personal don't anticipate anything being released prior to that, but certainly it could come at any time.
if they choose to release data from the first 30 enrolled hitting 8 weeks, then it would be a month earlier. i just think end of april, or even start of may, is when i might start checking for news daily and expecting to see something "any day".
hoping that they don't get that far and then say "ok now we have 8 week data on 40 patients, but we've enrolled all 60, so let's just wait another 8 weeks". i don;t expect that but when pondering the timeline that came to mind. i'd guess that's something like a 25% chance at most. someone "in the room" at the time might mention the possibility.
Here is what i am contemplating.
December January enrollment leaks indicates perhaps 10 per month. That is always something you are guessing at but let's just call it that. 30 enrolled by end january and 40 by the end of february. trial document says 30/30 at 350/700mg. dsmb may have greenlighted 700mg enrollment after 20 enrolled. either way...
if they are truly going to share interim data, and i expect they likely will be, based upon how small biotechs generally operate, how cydy has done things b4, and i guess a hint to that effect from hoffman?... then i would expect them to wait until they have pd-1 levels from both 350 and 700mg patients. and i'd expect the minimum breakdown to be 20/10 or 30/10 (or 20/20). i think they might not consider sharing until they have data from 30 or 40 patients so that they can show the superiority at 700mg. seems silly not to wait until you have that, as 700mg will ultimately be the dose that they pursue and which the fda has always supported.
also i assume that 4 week PD-1 data is the bare minimum, but 8 weeks might make more sense. i haven't looked back at their data from tnbc lately, but i think the max pd-1 levels were in a large-ish range? 4 to 12 weeks? anyway 8 weeks from end february (40 enrolled?) is roughly end of april.
i personal don't anticipate anything being released prior to that, but certainly it could come at any time.
if they choose to release data from the first 30 enrolled hitting 8 weeks, then it would be a month earlier. i just think end of april, or even start of may, is when i might start checking for news daily and expecting to see something "any day".
hoping that they don't get that far and then say "ok now we have 8 week data on 40 patients, but we've enrolled all 60, so let's just wait another 8 weeks". i don;t expect that but when pondering the timeline that came to mind. i'd guess that's something like a 25% chance at most. someone "in the room" at the time might mention the possibility.
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