RE: Investment case9 May 2023 21:23
david and amones - this is going back over old ground, but i believe the surufatinib rejection was more a case of bad timing….innovent working with lilly tried to get a drug approved without even doing the bridging study that hcm did. the fda did appear to accept the bridging approach, but during its assessment period held a meeting that changed its policy requiring more specific data relevant to us….that is what was cited by innovent when it got its crl. the fda should have been able to inform the company at the time…or maybe the company should have seen the way the wind was blowing and done more work…..
the bridging study was always a risky short cut….we should assume that most of the phii registrational intent studies will need a confirmatory ph iii (as savo has in china)….there are not many shortcuts to success you just need high levels of effective patient response to treatment and that is very very hard…..as the competition raises the bar….fru*****inib may well get its approval in china, but it is risky to take it to the us as it did not boost overall survival so may not be markedly better than the competition.