What we know is our own study shows we increase life expectancy over the current standard of care and do so in more suffers from the current standard of care.
we didn’t meet some unknown condition (to us) that would enter us into stage 2 with an extra 50 patients
but we fully recruited stage 1 with 150 patients and these patients will go full cycle.
it may well be that the condition for stage two is above where we perform but that we still provide a reasonable level of toxicity and also an increase in life expectancy above the current standard of care.
we may well still get FDA approval for GBM as a single medication - either way I agree the in combination studies and DIPG are very exciting.
what we also know is no other arm has entered stage 2 as yet either but hopefully we may do so in combination.
even though we do not enter stage 2 we are now currently in 150 odd patients and that data is being collected - if there was some horrible toxicity they would remove these patients but that’s not the case
and if we fell short of criteria for stage two how short? - we don’t know.
there is every chance we will perform as per the results of the study we have already completed and those show results are better than the current standard of care and in 60% more patients
so in this biotech area and in this climate the market is severely over reacting to any unknown - we may well be performing exactly as we did in the first study with the same results.
we just didn’t meet the criteria for stage two - without known what that criteria is.
we also know no other drug has progressed to stage two as yet either - we may well be the top perform drug currently and with exciting combination therapies.
as needle mentioned and as others are finding cancer drugs and other drugs used in combination with ketosis (fat burning rather than glucose burning diets) shows greater efficacy of the drug.
there’s lots going on and we may well be right on the results we already had as indicated.
i think the market is over reacting and I acquired yesterday - time will tell how good a decision that is…
for me there is too many good studies going on here and it’s never a linear path even GBM is not dead as the emotional will have us believe it simply didn’t meet conditions to expand the cohort in the second stage by 50 patients, it did show enough comfort to let 150 patients continue through the process and collect data.
