That would be a BIG move Riz, wouldn't it? Yes, e
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Posted On: 11/25/2022 9:34:25 AM
That would be a BIG move Riz, wouldn't it?
Yes, everyone is expendable, but at what cost?
Recknor was/is in the heart of it. In the midst of the Raw Data, aggregating it.
Working with the CRO for PharmacoVigilance, he knows the depths and the details of what Amarex did wrong.
Sure, there is the CRO there, there is now 3x external auditors who also know, even Sidley Austin knows it, but also referring back to conference call 6/28/22:
and we have learned that a total of 4 external auditors were brought in.
So, my point here is that Chris Recknor has the information, but there are a few internal people who have taken responsibility for that data. Likely Meidling and Cunningham. The pertinent points about Amarex's failings have been transferred to these individuals and to Sidley Austin.
What about his work for NASH. Recknor was in the heart of that. He was determining the findings and the interpretation of the 350 NASH and 700mg NASH data. 350 was looking great and it still does. 700HM looks great, but not 700mg. Ohm thinks CRO botched the laboratory analysis. Could be.
Recknor was looking into it further. But his time was consumed with Amarex past 6 months.
EASL was quite a deal according to Kelly. Noureddin will be stating to what extent hopefully on 12/7.
I believe Recknor was onto something with 700mg NASH, but not sure if his findings were communicated to Noureddin.
What you are hinting towards, a Buy Out or a partnership is possible which means that the company doing the buy out feels they have already what Recknor has and they can take his data and work out the answer for them selves.
In any event, we have Cyrus Arman who is doing the decision making. At a time when CytoDyn is at nearly its wits end, are you going to cut one of your top guys and cut your knowledge base of the molecule and how it works if that information would also be sacrificed. I think if this decision was made to let Recknor go, it would have meant that everything Recknor provided for the company would remain, and that it would only mean that Chris needed to leave for what ever reason, personal or business related.
Cyrus made the decision if in fact a decision was made and because of the person making the decision, I respect it as the way forward.
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Now if I had to guess as to a reason why Recknor may have left, it would have to do with a disagreement he could have made with Arman about not submitting the BLA. I'm definitely not saying that Recknor did that, I just venturing up a hypothetical guess as to what may have led to this given how hard he worked on aggregating the raw data and determining first hand that leronlimab was safe and effective regardless of how pitiful the quality of the trials were conducted.
Yes, everyone is expendable, but at what cost?
Recknor was/is in the heart of it. In the midst of the Raw Data, aggregating it.
Working with the CRO for PharmacoVigilance, he knows the depths and the details of what Amarex did wrong.
Sure, there is the CRO there, there is now 3x external auditors who also know, even Sidley Austin knows it, but also referring back to conference call 6/28/22:
Quote:
18:50 Antonio Migliarese: Thanks Scott. ... all hands on deck effort. ...we have a strong project team in place, which is led internally, by ... Joe Meidling and ...Bernie Cunningham. We've additionally engaged in CRO, clinical research organization ... in the areas of pharmacovigilance, safety data based management analysis. ... regulatory consulting firm that is assisting us with the preparation and review of the various regulatory communication, and lastly we have the data to work with an overall regulatory strategy advising group. This group is one of the most reputable at being regulatory consulting firms led by former FDA regulators.
... Furthermore, this allows us to identify opportunities to bring in additional resources and where if possible to expedite time.
and we have learned that a total of 4 external auditors were brought in.
So, my point here is that Chris Recknor has the information, but there are a few internal people who have taken responsibility for that data. Likely Meidling and Cunningham. The pertinent points about Amarex's failings have been transferred to these individuals and to Sidley Austin.
What about his work for NASH. Recknor was in the heart of that. He was determining the findings and the interpretation of the 350 NASH and 700mg NASH data. 350 was looking great and it still does. 700HM looks great, but not 700mg. Ohm thinks CRO botched the laboratory analysis. Could be.
Recknor was looking into it further. But his time was consumed with Amarex past 6 months.
EASL was quite a deal according to Kelly. Noureddin will be stating to what extent hopefully on 12/7.
I believe Recknor was onto something with 700mg NASH, but not sure if his findings were communicated to Noureddin.
What you are hinting towards, a Buy Out or a partnership is possible which means that the company doing the buy out feels they have already what Recknor has and they can take his data and work out the answer for them selves.
In any event, we have Cyrus Arman who is doing the decision making. At a time when CytoDyn is at nearly its wits end, are you going to cut one of your top guys and cut your knowledge base of the molecule and how it works if that information would also be sacrificed. I think if this decision was made to let Recknor go, it would have meant that everything Recknor provided for the company would remain, and that it would only mean that Chris needed to leave for what ever reason, personal or business related.
Cyrus made the decision if in fact a decision was made and because of the person making the decision, I respect it as the way forward.
---
Now if I had to guess as to a reason why Recknor may have left, it would have to do with a disagreement he could have made with Arman about not submitting the BLA. I'm definitely not saying that Recknor did that, I just venturing up a hypothetical guess as to what may have led to this given how hard he worked on aggregating the raw data and determining first hand that leronlimab was safe and effective regardless of how pitiful the quality of the trials were conducted.
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