RE:RE:RE:RE:RE:Very encouraging, but approval will take time Obviously more resources to throw at this the better but you're don't taking a practical approach here. Take the next trial. From the PR it seems 6+6 (+ a further4 if all is OK). That is presumably a restriction put on by the fda because they need to see how toxicity develops in this new regimen. Having billions in the bank wouldn't remove that restriction.
Like everybody else you want the answer to 100 different questions. Unlike everyone else you don't take account of how the real world works.
jfm1330 wrote: Marsolais clearly said all patients have biopsies at baseline to do corellation with efficacy afterward. That being said, I will listen again tothe presentation since a lot of things were said.
That being said, I think they have something in their hands, but they lack the financial ressources to drive it. They need a big partner with ressources to do many things at the same time. Now they will spend most of the next year in a small phase I. Then they will need a phase II and a phase III. They can hope for approval based on PFS, not on ORR. THe PFS path take a lot longer and with much more patients.
SPCEO1 wrote: To me, the biopsy situation is as clear as mud. It was mentioned in the poster and again today but I don't believe every patient is biopsied. My cousin was not biopsied as far as I know.
jfm1330 wrote: Another thing I learned today is that they do a biopsy on all patients before starting them on the drug. Maybe I missed it previously, but it changes the situation they are in. It seems that the FDA is asking them to do that, but not to use it as a selection tool. The FDA is also thinking in an ADC way, not in a PDC way. They look at how it was done before with ADCs, and forget that TH1902 is a PDC. Both targeted therapies, yes, but very different.