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Posted On: 09/30/2024 3:27:43 PM
Post# of 148866
I wonder how many trials are run like this one and use misleading data for the apparent purpose of raising funds
Cassava Sciences and two of its former executives have reached a resolution with the SEC over charges of “misleading” investors about the strength of data from a mid-stage Alzheimer’s disease study.
The Austin, TX-based biotech will pay a $40 million penalty but has neither admitted nor denied the charges in a company release Thursday.
The SEC charge concerns the reporting of results from a Phase 2b trial of Cassava’s Alzheimer’s drug candidate simufilam. The agency claims in a Thursday filing at the US District Court for the Western District of Texas that Cassava consultant Hoau-Yan Wang received information that unblinded him to some parts of the study and used this information to “create the appearance” of “dramatic improvements” in certain disease biomarkers.
Cassava and Burns then allegedly misled investors by claiming that Phase 2b was blinded. The company also said the data suggested significant improvements in episodic memory based on a subset of patients “hand-selected by Burns” instead of the full patient data, which showed no such improvement, according to the SEC. As for Barbier, he and Cassava failed to disclose Wang’s role in the trial.
After the readout, the company went on to raise more than $260 million in new funding.
https://endpts.com/cassava-and-its-former-exe...drug-data/
Cassava Sciences and two of its former executives have reached a resolution with the SEC over charges of “misleading” investors about the strength of data from a mid-stage Alzheimer’s disease study.
The Austin, TX-based biotech will pay a $40 million penalty but has neither admitted nor denied the charges in a company release Thursday.
The SEC charge concerns the reporting of results from a Phase 2b trial of Cassava’s Alzheimer’s drug candidate simufilam. The agency claims in a Thursday filing at the US District Court for the Western District of Texas that Cassava consultant Hoau-Yan Wang received information that unblinded him to some parts of the study and used this information to “create the appearance” of “dramatic improvements” in certain disease biomarkers.
Cassava and Burns then allegedly misled investors by claiming that Phase 2b was blinded. The company also said the data suggested significant improvements in episodic memory based on a subset of patients “hand-selected by Burns” instead of the full patient data, which showed no such improvement, according to the SEC. As for Barbier, he and Cassava failed to disclose Wang’s role in the trial.
After the readout, the company went on to raise more than $260 million in new funding.
https://endpts.com/cassava-and-its-former-exe...drug-data/
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