“I’m pretty sure he said he was using the 5 to
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Posted On: 09/23/2020 9:35:48 AM
Re: Riztheinvestor #57469
“I’m pretty sure he said he was using the 5 to submit data to the FDA.”
BTD seems unlikely with only 5 patients. Ohm mentioned there 5 patients is the minimum for BTD and I hope that’s what NP was referring to.
The other issue could be the lower dosing of 350 and 525 in the mTNBC trial. The lower doses had to be enrolled first, which means the first 12 patients in the trial got the 350 or 525. We know now that the 525mg does in the basket trial isn’t showing the expected results and that Dr. L has requested to increase it to 700mg. This could be the same for the mTNBC trial and thus the data from the first 12 patient isn’t consistent resulting in the BTD application containing a small number of patients.
BTD seems unlikely with only 5 patients. Ohm mentioned there 5 patients is the minimum for BTD and I hope that’s what NP was referring to.
The other issue could be the lower dosing of 350 and 525 in the mTNBC trial. The lower doses had to be enrolled first, which means the first 12 patients in the trial got the 350 or 525. We know now that the 525mg does in the basket trial isn’t showing the expected results and that Dr. L has requested to increase it to 700mg. This could be the same for the mTNBC trial and thus the data from the first 12 patient isn’t consistent resulting in the BTD application containing a small number of patients.
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