"OK - agree with you about Doxyrubicin but I thought that as of recently Doxil was back on the market (someone else was approved to make it...) so I thought that we were back to the original trial design. No matter what - as long as we show non-inferiority with much better toxicity then we will be approved and the market will be large"
"No matter what" is not good enough for FDA. If we want the drug to be approved, we need the toxicity to be a primary endpoint in a new designed phase 3 trial. Of course, if the OS is not compromised.
You know, this new AESZ-108 story starts to remind me perifosine fiasco. The rationale for OS benefit is not clear. I do not understand why AEZS did not conduct a small phase 2 study comparing the effects of 108 and doxorubicin on OS before starting a phase 3 trial. Historical data comparison is not convincing. May be it is a reason why potential partners are not interested.