As you asked me before, whether TACTI002 can just get through...

As you asked me before, whether TACTI002 can just get through approval on 114 patients. I still think the cohort size is less of an issue, but it is that TACTI002 is not a randomised controlled trial and also being a combo therapy, EFTI+Keytruda (dual mechanism). Usualy, in this case, FDA would want to see a controlled arm within the same trial. In many cases, dual mechanism got some hard to explain observations, FDA has to make sure the good results are not largely because the combined agent, here, Keytruda alone.

So when we come to TACTI004 (assuming to be fully controlled), I do think there is very good chance accelerated approval could land. Maybe by the stage we have ORR readout. This could also happen in one of the sub-groupd instead of the whole cohort, again, can be time reduced.

I still think there is good chance the AA will be given to PD-L1 low or negative population, depending on the trial design (4 more weeks to find out?). That 's the most problematic population, with pretty much the only choice being strong chemo plus PD1 treatment (not talking about the mutation basis drug, comparison here is more of universal screening.), but that goes faliure easily from what we have seen so far.