That they wiped out so much on the company website
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Posted On: 05/28/2022 9:56:13 PM
That they wiped out so much on the company website says they're willing to throw the baby out with the bathwater. Urbach may think another BTD submission would just irritate the FDA. But if we have numbers good enough to stomp Trodelvy then it should be submitted.
Urbach is most likely looking at it through the narrow lens of her compliance work. But the FDA is tasked with ensuring safety to consumers and the regulation of bringing safe and effective drugs to the marketplace. If a biopharma has a safe and effective drug that will save lives or alleviate suffering then it is a moral duty to try and get that drug approved as quickly as possible. If you're afraid some FDA bureaucrats might be upset then agreed you're in the wrong business.
Urbach is most likely looking at it through the narrow lens of her compliance work. But the FDA is tasked with ensuring safety to consumers and the regulation of bringing safe and effective drugs to the marketplace. If a biopharma has a safe and effective drug that will save lives or alleviate suffering then it is a moral duty to try and get that drug approved as quickly as possible. If you're afraid some FDA bureaucrats might be upset then agreed you're in the wrong business.
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