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id: 452, Created by Stan Vick, Scout
Eiger Biopharmaceuticals Inc
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On October 5, 2022, Eiger (EIGR) announced that it would not seek an EUA request for peginterferon lambda after the FDA had “denied the request for a pre-EUA meeting.”
Specifically, the Company disclosed that, “citing its concerns about the conduct of the TOGETHER study, the FDA concluded that any authorization request based on the data is unlikely to meet the statutory criteria for issuance of an EUA in the current context of the pandemic.”
Investors have reasons to suspect that the Company and its Leaders violated rights of shareholders by:
- overstating its expertise in regulatory drug development to investors.
- fail to properly assess problems with its TOGETHER trial and determine if the trial could support the peginterferon lambda EUA. Based on these problems with the trial, the FDA was unlikely to approve the Company’s EUA.
Failure to Disclose,
Shock Event Date
04 October 2022