RE:RE:RE:RE:RE:Very encouraging, but approval will take timeBased on Juniper 88's comment and what you heard, I ithink biopsies were likely given to all patients, including my cousin and she just never mentioned it. But if biopsies were given to all, then should they not know the sortilin overexpression for each?
Money is defintely an issue for THTX. I suspect the hope is they see some early success with the six initial patients, announce that and then raise new equity capital and/or sign a partnership deal on the back of that. If they don't see early success, then it might get a bit more difficult on the cash front, depending on sales success from the legacy drugs. If THTX knows they have something with TH-1902, then they could opt to raise money by selling rights to the legacy drugs future revenues - see what OMER did with its lone drug to raise money to keep funding it research on bigger and better drugs in its pipeline.
If you ask me, if they can get proof of concept, it seems TH-1902 should be partnered with a large drug company with the financial resources to exploit it in a more fully and in a more timely manner. But that is just my not-fully informed opinion and is based not as much as a shareholdere but as a fellow human being wanting cancer sufferers to get as much help as they can as soon as they can.
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.