Ok. I have just found something that is confusing
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Posted On: 04/03/2020 6:58:41 PM
Ok. I have just found something that is confusing:
I have been operating under the assumption that the upcoming BTD meeting with the FDA was to address shortcomings in the mTNBC submission. More specifically, to possibly address potential shortcoming with either the methodology, number of patients, documentation, or some other deficiency that prevented them from granting the BTD.
In composing my last post, I found myself listening to the last minute of the TD Ameritrade video from yesterday. Starting at 4:40 of that of the video, NP says:
"same scientist told us about the cancer, and the result of the cancer we are filing for Breakthrough Designation which we are now about to (stutter) ask the FDA to have a meeting with us for preliminary BTD for 22 different cancer indications"
Of course, I have also re-read the press release from earlier today.
But I am still left asking, is meeting limited to mTNBC and MBC -- or does it also include a BTD discussion relating to the 22 solid tumors in the Basket Trial?
I have been operating under the assumption that the upcoming BTD meeting with the FDA was to address shortcomings in the mTNBC submission. More specifically, to possibly address potential shortcoming with either the methodology, number of patients, documentation, or some other deficiency that prevented them from granting the BTD.
In composing my last post, I found myself listening to the last minute of the TD Ameritrade video from yesterday. Starting at 4:40 of that of the video, NP says:
"same scientist told us about the cancer, and the result of the cancer we are filing for Breakthrough Designation which we are now about to (stutter) ask the FDA to have a meeting with us for preliminary BTD for 22 different cancer indications"
Of course, I have also re-read the press release from earlier today.
But I am still left asking, is meeting limited to mTNBC and MBC -- or does it also include a BTD discussion relating to the 22 solid tumors in the Basket Trial?
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