CYDY submitted multiply application to FDA for BTD
Post# of 157853
(Total Views: 291)
Posted On: 10/13/2025 1:55:30 PM
Re: KenChowder #157847
CYDY submitted multiply application to FDA for BTD for the treatment on mTNBC
January 30 , 2020 application , this application was based on 2 patients .
The first patient was from our phase 1b/2 trial for mTNBC.
The second patient was from eIND treatment for HER2+ metastatic , stage 4 breast cancer , I believe this was M-i-L
Then November 8 , 2021 application was submitted for another BTD in treatment of mTNBC.
This submission was based on analysis of data from a pooled population of our 28 patients with mTNBC.
Those were the patients ,
--10 from phase 1b/2 in mTNBC
--2 from basket trial.
--16 from compassionate use ..
I believe now in 2025 with our 5 patients from the 28 surviving that long.
We will have a very good chance for BTD ,
Just need to apply..
January 30 , 2020 application , this application was based on 2 patients .
The first patient was from our phase 1b/2 trial for mTNBC.
The second patient was from eIND treatment for HER2+ metastatic , stage 4 breast cancer , I believe this was M-i-L
Then November 8 , 2021 application was submitted for another BTD in treatment of mTNBC.
This submission was based on analysis of data from a pooled population of our 28 patients with mTNBC.
Those were the patients ,
--10 from phase 1b/2 in mTNBC
--2 from basket trial.
--16 from compassionate use ..
I believe now in 2025 with our 5 patients from the 28 surviving that long.
We will have a very good chance for BTD ,
Just need to apply..
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