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Posted On: 05/20/2022 11:44:09 PM
Post# of 148899
CytoDyn should already have BTD for mTNBC.
Compared with Trodelvy, at the time, we had equal efficacy.
Currently, we blow it out of the water and if you consider our side effect profile vs. theirs.
But, what may explain the situation a little better is the quality of the patient pool. The 28 patients in that trial were patients that had already failed 2 other lines of previous therapy. They came from the compassionate use program, the Phase 1/B2 clinical trial and the basket trial.
These patients were sicker than dogs. Gilead with Trodelvy had much healthier patients. It was not apples to apples. It was apples to rotten apples and we still matched their OS. The best they could do with a superior patient pool. Possibly, should consider that, maybe these patients were growing sicker by the day and CytoDyn just called it off, but, I think they would have called it in February or so. If they called it in February, then we should at least be able to claim OS of 16 months, apparently, not good enough to meet BTD even when we had one arm tied behind our backs.
When the trial closed in November 2021, there remained patients on Leronlimab. Kelly says there is a high bar for breakthrough designation and he did not believe that the remaining patients on LL would be sufficient for BTD. So he is saying that patients remain on LL, so what is that high bar he is referring to which we can't meet if patients remain on LL? I know, paying off FDA.
Kelly said last in his answer in the conference call, "So we will be progressing this molecule forward for mTNBC and looking for more development opportunities."
Compared with Trodelvy, at the time, we had equal efficacy.
Currently, we blow it out of the water and if you consider our side effect profile vs. theirs.
But, what may explain the situation a little better is the quality of the patient pool. The 28 patients in that trial were patients that had already failed 2 other lines of previous therapy. They came from the compassionate use program, the Phase 1/B2 clinical trial and the basket trial.
These patients were sicker than dogs. Gilead with Trodelvy had much healthier patients. It was not apples to apples. It was apples to rotten apples and we still matched their OS. The best they could do with a superior patient pool. Possibly, should consider that, maybe these patients were growing sicker by the day and CytoDyn just called it off, but, I think they would have called it in February or so. If they called it in February, then we should at least be able to claim OS of 16 months, apparently, not good enough to meet BTD even when we had one arm tied behind our backs.
When the trial closed in November 2021, there remained patients on Leronlimab. Kelly says there is a high bar for breakthrough designation and he did not believe that the remaining patients on LL would be sufficient for BTD. So he is saying that patients remain on LL, so what is that high bar he is referring to which we can't meet if patients remain on LL? I know, paying off FDA.
Kelly said last in his answer in the conference call, "So we will be progressing this molecule forward for mTNBC and looking for more development opportunities."
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