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Saturday, July 10, 2021 8:12:20 AM
An excerpt from the Pestell vs CytoDyn lawsuit filed in August 2019:
64. Although Dr. Pestell and the CEO initially maintained a cordial working relationship, their relationship rapidly deteriorated following Dr. Pestell’s objections in late June 2019 to the CEO concerning an investigational new drug application (“IND”) and protocol to be submitted to the FDA despite the fact that Dr. Pestell, as the CMO, and another expert had determined that the protocol, as then drafted, was not safe for the study subjects.
65. Specifically, on June 20, 2019, the CEO, who has no medical training, demanded that the clinical trial office at Amarex Clinical Research LLC (“Amarex”) “submit the IND and protocol that you had made for colon cancer for submission to the FDA by tomorrow and let [Professor] John [Marshall, Consultant to CytoDyn] know that we are not waiting for him any longer.”
66. Dr. Pestell pushed back on the CEO’s attempts to rush the submission because, the week prior, on June 12, 2019, Dr. Pestell had determined that the protocol was unsafe because it would likely lead to a higher incidence of side effects, placing patients at unnecessary risk. For those reasons, Dr. Pestell and Professor Marshall, a colon cancer subject matter expert who had previously worked with Dr. Pestell from 2002 to 2005 and is currently a consultant to CytoDyn, agreed that changes should be made to the protocol.
67. Dr. Pestell, Professor Marshall, and Amarex recommended a safer and more efficacious revised protocol, which adjusted the dose and timing of the chemotherapeutic agent to be provided to patients. The initial draft study proposed a daily 160 mg starting dose of regorafenib, plus weekly subcutaneous administration of leronlimab. However, regorafenib can have severe side effects at that starting dosage, which research has shown are lessened by starting with a lower dose, which is then gradually escalated. The protocol revision endorsed by Dr. Pestell, Professor Marshall, and Amarex accordingly recommended a dose escalation of 80, 120, and 160 mg of regorafenib, in combination with the administration of leronlimab.
68. Despite this recommendation from experts in the field, and despite Dr. Pestell’s authority for leading and implementing the Company’s clinical programs, the CEO instead proposed submitting the original protocol with Dr. Pestell’s name removed. This interference with Dr. Pestell’s authority and performance of his duties constituted a breach of Section 2.2 of the Employment Agreement.
69. Ultimately, Amarex declined to submit the original protocol, and only then did the CEO relent and follow Dr. Pestell’s recommendation.
70. Over the course of the following weeks, however, the CEO embarked on an effort to retaliate against Dr. Pestell by obstructing his ability to carry out his responsibilities, relieving him of his authority over various matters, and ultimately leading the effort to terminate his employment.
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