(Total Views: 379)
Posted On: 04/06/2019 2:08:14 PM
Post# of 154883
Thank you Trding , good information ,
I believe very strongly that if results in TNBC will be very good and no serious side effects will show when Leronlimab is given with chemotherapy , it has a very good chance to be approve before combo .
We were talking if TNBC is label extansion study , and to my knowledge it is not ..
but if results will be good and no side effects happen , it is not very important , FDA will work with them ..
They have lot of information from combo and they will have some from TNBC, so it is really not that important how they calling this study now ..
Mono - pivotal most probably will be approve as label extansion study .
I believe very strongly that if results in TNBC will be very good and no serious side effects will show when Leronlimab is given with chemotherapy , it has a very good chance to be approve before combo .
We were talking if TNBC is label extansion study , and to my knowledge it is not ..
but if results will be good and no side effects happen , it is not very important , FDA will work with them ..
They have lot of information from combo and they will have some from TNBC, so it is really not that important how they calling this study now ..
Mono - pivotal most probably will be approve as label extansion study .
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