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2021.2.16

Madrigal: Leading Biotech In Race For NASH Approval That Nobody Has Been Able To Win

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seekingalpha.com/article/4406410-madrigal-leading-biotech-in-race-for-nash-approval-nobody-able-to-win

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·|­û¡GROGER588910148151 µoªí®É¶¡:2020/7/27 ¤U¤È 10:51:23²Ä 217 ½g¦^À³

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·|­û¡GROGER588910148151 µoªí®É¶¡:2020/7/17 ¤U¤È 10:56:33²Ä 168 ½g¦^À³

AAPM 2018¦~·|ºK (SNP-810)

...Acetaminophen (AAP) is the leading worldwide cause of drug-induced acute liver failure (ALF)

... could maintain normal hepatic function even with AAP doses of 2000 mg/kg, demonstrating a protective index (LD50) of more than 4X. These CYP450 inhibitors (referred to as antidote, research code: SNP-810) reduced AAP-induced hepatotoxicity by lowering the levels of aspartate aminotransferase, alanine aminotransferase, histology activity index (HAI-score) and inhibition of NAPQI formation (as shown by AAP-Cys, a biomarker representing NAPQI) (p < 0.005). The survival was 100% (24/24) in a majority of antidote-treated groups, whereas the survival rate was 17% (2/12) in AAP-only group and 50% (6/12) in the NAC-treated group.

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·|­û¡GROGER588910148151 µoªí®É¶¡:2020/7/3 ¤W¤È 08:05:38²Ä 35 ½g¦^À³

Comparison of the Efficacy of Oral SNP-610 & Ocaliva (Intercept)*

SNP-610 shows a greater reduction of ALT

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Frequently Asked Questions: Breakthrough Therapies

5.Is there a deadline for a sponsor to submit a request for breakthrough therapy designation?

The Food Drug and Cosmetic Act (21 USC 356) states that a request for a breakthrough therapy designation may be made concurrently with, or at any time after, the submission of an application for [the IND].

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www.gbimonthly.com/2018/11/36246/

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n.yam.com/Article/20201012720058

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