(Total Views: 493)
Posted On: 06/08/2019 1:07:37 PM
Post# of 156842
I dont believe that TNBC can be approved as off label to combo.
Our pivotal mono , yes.
And as you said we can have off label with other cancers from TNBC , but I believe they will do like Keydruda did , by MOA .
This is why I don't believe approval or not of Combo is significant for our cancers.
And I am not sure which one will be approve first...
Probably depend if CTC is reduced in first 21 days ...
The only significant thing is observation of safety of Leronlimab , they still asking for few patients with chemotherapy to be sure , but 3,3 and 3 is a very low number.
This telling me that FDA feel very comfortable with Leronlimab.
Our pivotal mono , yes.
And as you said we can have off label with other cancers from TNBC , but I believe they will do like Keydruda did , by MOA .
This is why I don't believe approval or not of Combo is significant for our cancers.
And I am not sure which one will be approve first...
Probably depend if CTC is reduced in first 21 days ...
The only significant thing is observation of safety of Leronlimab , they still asking for few patients with chemotherapy to be sure , but 3,3 and 3 is a very low number.
This telling me that FDA feel very comfortable with Leronlimab.
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