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Posted On: 02/19/2022 8:03:18 PM
Post# of 155738
Re: Goosebumps #118680
Goose,
Isn’t it correct that after Trodelvy was approved for mTNBC, that a Break Through Designation isn’t possible. I think I may have misstated that a BTD would be a goal for mTNBC. Rather becoming or outperforming the SOC would be the goal.
Either way.
BTD for NASH
SOC/BLA for mTNBC
PDUFA for HIV BLA
Bits from Brazil
LH protocol
In my opinion equals…BUYOUT.
If your Large Pharma Company wants to control Leronlimab and protect your pipeline, you best act fast. The time is now. It won’t get cheaper.
“ On April 7, 2021, the Food and Drug Administration granted regular approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.”
chazzle
Isn’t it correct that after Trodelvy was approved for mTNBC, that a Break Through Designation isn’t possible. I think I may have misstated that a BTD would be a goal for mTNBC. Rather becoming or outperforming the SOC would be the goal.
Either way.
BTD for NASH
SOC/BLA for mTNBC
PDUFA for HIV BLA
Bits from Brazil
LH protocol
In my opinion equals…BUYOUT.
If your Large Pharma Company wants to control Leronlimab and protect your pipeline, you best act fast. The time is now. It won’t get cheaper.
“ On April 7, 2021, the Food and Drug Administration granted regular approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.”
chazzle
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