I for one do. Look Cyrus was brought on a preside
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Posted On: 10/25/2022 6:55:00 AM
I for one do. Look Cyrus was brought on a president, not CEO. Before being brought to the Board as CEO, he would have to get the company out of a certain situation, namely, this hold. Getting a partnership would also grant him that elevation.
6/30/22 conference call:
Cyrus recognizes he needs a head of Audit Committee.
9/28/22 conference call:
Lastly, the Investigator's Brochure, the iSS and ISE have been submitted to the FDA. Integrated Summaries of Safety and Effectiveness.
A few more documents may need to be submitted. They got the warning banner lifted. I think the hold is right around the corner. I like 11/11/22.
I say all this because Cyrus was brought on a president, not ceo. They gave him 6 months to earn CEO. 7/9/22 + 6 months is 1/9/23. So by then, he should have a partnership under his belt. And a partnership does not happen if a clinical hold is in place. So, I see this hold being lifted very soon and then the revelation of the NDAs which will lead to the closing of the deals.
6/30/22 conference call:
Quote:
So, it is my true pleasure to announce that Dr. Cyrus Arman, PHD has been named President of CytoDyn. Dr. Arman is anticipated to advance to Chief Executive Officer and to join the companies Board of Directors within 6 months. During his initial term as president, Dr. Arman will devote substantial focus to the immediate operational needs of the company, and to further the developing and refining the companies strategic plans.
Antonio Migliarese, who has served as interim president as well as CFO since late January, will continue to serve as Chief Financial Officer. Dr. Arman employment with CytoDyn will begin July 9, 2022. Dr. Arman is reputed to be an exceptional 1st principle thinker, able to work to both scientific and commercial considerations to evaluate probabilities of success in sizing the market to develop different criteria's for forced ranking opportunities. Throughout his career, he has repeatedly led wargame events, where clients had to role play as their own competitors in an effort to understand how their decisions fit in the larger context of their market. He is known to be a quick learner, to be analytical and methodical in thought processes, a tireless worker and to have an incomparable sense of duty. The board could not be more excited about Dr. Arman's incoming leadership and he has our unanimous full support.
Cyrus recognizes he needs a head of Audit Committee.
9/28/22 conference call:
Quote:
In early 2022, the board has identified the need to recruit a board member with substantial audit experience. Ideally, a mix of big firm audit, and chief financial officer experience, who could leverage his/her professional background on behalf of the board, and who could chair the audit committee.
A culmination of these efforts was the announcement on August 30, 2022, of Ryan Dunlap appointment to CytoDyn board of Directors.
Quote:
Quite literally, everything else will come down to leadership , experience, most importantly, the ability to execute. I want to be clear, that achieving everything I just described, is going to take a new level of focus. and More importantly, A new level of discipline that the company has not had before. but that I am completely committed to executing on. This Plan is Not just Limited to Development strategy or to Resource allocation, but it is a Core theory of how our business now operates. To put it simply. What got us here today, is not what will lead us into the future.
Quote:
With regard to the clinical hold, we believe we now have the required data from Amarex to address the FDA's concerns. However, as we previously seen hinted in last quarterly call, the data from Amarex is not covered in the industry standard format. While this barrier has extended our desired response Timelines to FDA, it has recently been mitigated by actions from leadership, and I am pleased to announce, that during the month of September, the first of a series of docs are in line for submission to the FDA, and we continue to move as quickly as possible on the remaining items. It is important to note, that substantially all of the data requested by the FDA that lifts the clinical hold, are items that Amarex was contracted by CytoDyn to prepare, but failed to do so. As a result, CytoDyn has taken on all of these responsibilities internally over the last 6 months. Along these lines, we have also recently completed the warning letter close out process with the office of prescription drug promotion, and we look forward to continue to improve our relationship with the FDA at all levels.
Lastly, the Investigator's Brochure, the iSS and ISE have been submitted to the FDA. Integrated Summaries of Safety and Effectiveness.
A few more documents may need to be submitted. They got the warning banner lifted. I think the hold is right around the corner. I like 11/11/22.
I say all this because Cyrus was brought on a president, not ceo. They gave him 6 months to earn CEO. 7/9/22 + 6 months is 1/9/23. So by then, he should have a partnership under his belt. And a partnership does not happen if a clinical hold is in place. So, I see this hold being lifted very soon and then the revelation of the NDAs which will lead to the closing of the deals.
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