If you look at the history data with AG treatment option, on average patients died about 3-4 months after progression started. So the expected OS for PAG treatment should be about 9+3 or 4, or 12 to 13 months, which is not far aways from the 11.8 months reported if you considered the disruption of PAG treatment in the result.
With larger trial patients in P3, The OS data for AG group should go back to below 10 months, and for PAG group to go beyong 13 months, then we have an approveable drug.
I looked at the OS data from cancercenter.com for pancreatic cancer. 43% patients died within 6 months. 28% died within 12 months, 14% died within 18 months, and 5% died within 24 months. Even using the most optimistic number for calculation (e.g., all 43% died at exactly 6 months), the OS data is 9.6 months. PEG's 11.8 months of OS is certainly a good improvement. Hopefully the number of second phase of P2 trial will be better without treatment disruption.
This is wrong argument. If a pregnant woman knows a way to reduce the risk, she will always take it. The 3% of birth detect is due to uncontrollable reasons. It doesn't mean that pregnant women don't care because the percentage number is low.