The relationship between Amarex Clinical Research
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Posted On: 02/16/2024 2:53:05 PM
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The relationship between Amarex Clinical Research and CytoDyn, a biotechnology company, has been tumultuous and involves several issues, including:
Alleged data mismanagement and regulatory violations:
Dates: 2013-2021 (period during which Amarex provided services to CytoDyn)
Accusations:** CytoDyn alleges Amarex mishandled clinical trial data, leading to regulatory issues with the FDA. This allegedly impacted the development of CytoDyn's drug leronlimab, causing delays and ultimately withdrawal of an approval application. Both the FDA and independent audits reportedly identified problems with Amarex's services.
Legal disputes:
Dates: 2021-present
CytoDyn filed a lawsuit against Amarex in late 2021, claiming breach of contract and seeking damages exceeding $100 million. They also initiated arbitration through the American Arbitration Association in parallel.
Former CEOs charged with fraud: In December 2020, the Department of Justice charged the CEOs of both companies (Nader Pourhassan of CytoDyn and Kazem Kazempour of Amarex) with allegedly defrauding investors by exaggerating the progress of leronlimab and misleading about FDA submissions.
Current status:
The arbitration between CytoDyn and Amarex is ongoing, with CytoDyn recently requesting a final hearing date.
The criminal charges against the former CEOs are still pending.
It's important to note that these are allegations and accusations, and both sides have maintained their innocence. However, the situation highlights the complex and sometimes contentious relationship between contract research organizations (CROs) and pharmaceutical companies.
Here are some additional resources for further reading:
CytoDyn's press release: https://www.cytodyn.com/newsroom/press-releas...-community
Fierce Biotech article: https://www.justice.gov/opa/pr/two-biotech-ce...ud-schemes
Department of Justice press release: https://www.wsj.com/articles/two-biotech-ceos...1671575775
Alleged data mismanagement and regulatory violations:
Dates: 2013-2021 (period during which Amarex provided services to CytoDyn)
Accusations:** CytoDyn alleges Amarex mishandled clinical trial data, leading to regulatory issues with the FDA. This allegedly impacted the development of CytoDyn's drug leronlimab, causing delays and ultimately withdrawal of an approval application. Both the FDA and independent audits reportedly identified problems with Amarex's services.
Legal disputes:
Dates: 2021-present
CytoDyn filed a lawsuit against Amarex in late 2021, claiming breach of contract and seeking damages exceeding $100 million. They also initiated arbitration through the American Arbitration Association in parallel.
Former CEOs charged with fraud: In December 2020, the Department of Justice charged the CEOs of both companies (Nader Pourhassan of CytoDyn and Kazem Kazempour of Amarex) with allegedly defrauding investors by exaggerating the progress of leronlimab and misleading about FDA submissions.
Current status:
The arbitration between CytoDyn and Amarex is ongoing, with CytoDyn recently requesting a final hearing date.
The criminal charges against the former CEOs are still pending.
It's important to note that these are allegations and accusations, and both sides have maintained their innocence. However, the situation highlights the complex and sometimes contentious relationship between contract research organizations (CROs) and pharmaceutical companies.
Here are some additional resources for further reading:
CytoDyn's press release: https://www.cytodyn.com/newsroom/press-releas...-community
Fierce Biotech article: https://www.justice.gov/opa/pr/two-biotech-ce...ud-schemes
Department of Justice press release: https://www.wsj.com/articles/two-biotech-ceos...1671575775
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