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Posted On: 01/07/2020 10:36:59 AM
Post# of 153903
Great post.
My hope is that CTCs can be included for NP’s MIL and other patients under the emergency protocol as that gives another endpoint for the FDA to assess. The imaging is obviously important, but another endpoint in addition to how longer the patients survive with leronlimab will only make leronlimab’s case stronger.
But then again, is the data from the emergency patients who have a form of metastatic breast cancer going to be included in the BTD packet? Can it be included if the BTD is going to be for mTNBC? Or is CYDY going to file. BTD for general metastatic breast cancer?
My hope is that CTCs can be included for NP’s MIL and other patients under the emergency protocol as that gives another endpoint for the FDA to assess. The imaging is obviously important, but another endpoint in addition to how longer the patients survive with leronlimab will only make leronlimab’s case stronger.
But then again, is the data from the emergency patients who have a form of metastatic breast cancer going to be included in the BTD packet? Can it be included if the BTD is going to be for mTNBC? Or is CYDY going to file. BTD for general metastatic breast cancer?
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