From yesterday's HER2 results, I would say pozi would be approved eventually in 1st-line. They stopped cohort 4 after 70 patients instead of the possible 140 patients that they indicated. That means that either the FDA has enough info from all the cohort's BID dosing to be comfortable in combining the results of the once daily 16 mg dosing with the twice daily 8mg dosing (and in trying to contain expenses said that's good enough), or if not, maybe, SPPI has enough info from the data to plan running a larger P3 trial but I think it's the former.
Regarding egfr which was what you were asking about if not a typo, my guess is a solid "maybe". BID dosing did not seem to make much of a difference in HER2 first line but could it be that these patients are a lot less sicker and able to stomach the once daily 16mg dose much easier than a second or third line patient which was the case in cohort 1? If that is the case and a much sicker 2nd or 3rd line patient is able to stay on BID dosing longer that might make a considerable difference in efficacy and boost it over 20% from the 14.8% we saw in cohort 1. Also w cohort 1 there was, I suspect, a big learning curve in how to administer the drug which won't be the case if they run another trial. Hopefully, we'll get better color after the quarterly CC later this month.
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