Here is the main reason from the letter the Board
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Posted On: 08/28/2019 3:07:39 PM
Here is the main reason from the letter the Board gave for the firing.
Here is the initial issue RP said, a fight over the colon IND. CEO was pushing for the protocol to be submitted as is. The new protocol changed a starting dose at 160 to dose escalation of 80, 120, and 160 mg of regorafenib, in combination with the administration of leronlimab.
My obvious questions
1) Who created the first unsafe protocol?
2) How long had he worked on it? (does not say)
3) How hard would it take to switch 160 to escalating 80, 120, 160 mg?
For my impression NP thought RP was stalling. A timeline on this protocol would help here. If RP has been working on it for a couple weeks, yeah, I get RP's point. If RP had it on his desk for months, and said it would take a few more weeks to make that change, then I would side with NP.
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 agents 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.
Here is the initial issue RP said, a fight over the colon IND. CEO was pushing for the protocol to be submitted as is. The new protocol changed a starting dose at 160 to dose escalation of 80, 120, and 160 mg of regorafenib, in combination with the administration of leronlimab.
My obvious questions
1) Who created the first unsafe protocol?
2) How long had he worked on it? (does not say)
3) How hard would it take to switch 160 to escalating 80, 120, 160 mg?
For my impression NP thought RP was stalling. A timeline on this protocol would help here. If RP has been working on it for a couple weeks, yeah, I get RP's point. If RP had it on his desk for months, and said it would take a few more weeks to make that change, then I would side with NP.
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 agents 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.
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