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Posted On: 08/26/2024 4:54:13 AM
Post# of 148870
If the combining drug is off patent, and the possibility of gaining another patent is just about nil, that begs the question, Who then, can CytoDyn partner with on such a trial in MSS mCRC if there is no incentive for that BP to do so?
Doesn't this almost make the point that CytoDyn is faced with doing MSS mCRC alone?
If so, why do it using bevacizumab when ll does VEGF inhibition already? Yes, why not start pre-clinical, we are at $0.13 anyway? Why not go for monotherapy?
Yes, I know this Phase II will be quick as we are going for ORR and not OS or PFS, so ORR can be determined as quick as 3 months while OS needs over a year. So, maybe we can advance to Phase 3 much quicker if that is what you're thinking. Are there any advantages of using the chemo as well? Just to see how much better the chemo works when ll is added?
Can a Phase III be designed that only looks at ORR as end point if we go this quicker route? Do we need to look at OS and PFS in the Phase III in order to write a BLA and gain approval? or is OS an PFS also necessary for the BLA and approval?
Doesn't this almost make the point that CytoDyn is faced with doing MSS mCRC alone?
If so, why do it using bevacizumab when ll does VEGF inhibition already? Yes, why not start pre-clinical, we are at $0.13 anyway? Why not go for monotherapy?
Yes, I know this Phase II will be quick as we are going for ORR and not OS or PFS, so ORR can be determined as quick as 3 months while OS needs over a year. So, maybe we can advance to Phase 3 much quicker if that is what you're thinking. Are there any advantages of using the chemo as well? Just to see how much better the chemo works when ll is added?
Can a Phase III be designed that only looks at ORR as end point if we go this quicker route? Do we need to look at OS and PFS in the Phase III in order to write a BLA and gain approval? or is OS an PFS also necessary for the BLA and approval?
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