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Posted On: 06/17/2023 9:56:07 AM
Post# of 148899
Re: craigakess #135120
Either you misinterpreted my question or you re-phrased it.
I asked whether the decision made by the Arbiter in the current BINDING ARBITRATION is dependent on the result made by the FDA on the current lifting of the hold.
But somehow that got construed to say that the clinical hold is in some manner based on the result of the Amarex Arbitration. So if you thought I asked that, I apologize.
Here is what I wrote:
Your answer:
After the process which Cyrus headed over the past year, in obtaining the RAW data from Amarex, then setting up the internal audit committee, with FDA auditors and regulators, then hiring the 4 External FDA Type GCP Auditors, writing and submitting the Investigational Brochure, the 4 other documents which were submitted monthly, then the results of prior trials were validated against the audited data and posted to complete the prior trials. FDA had questions on benefits / risk analysis and now on hiv trial protocol.
Don't you think SA has access to the external auditor's findings and to all the submissions CytoDyn made to the FDA? All of that went to the FDA for the sake of lifting the hold, not for the sake of winning an arbitration.
Back up Arbiters?
Arbiter's decision?
Is their decision Binding even to them?
I asked whether the decision made by the Arbiter in the current BINDING ARBITRATION is dependent on the result made by the FDA on the current lifting of the hold.
But somehow that got construed to say that the clinical hold is in some manner based on the result of the Amarex Arbitration. So if you thought I asked that, I apologize.
Here is what I wrote:
Quote:
Do you feel the decision of this BINDING ARBITRATION waits for the result to lift the clinical hold? Do you feel / believe / know that the Arbiter's decision and size of the award is tied to whether the hold is lifted or not? This Arbiter's decision is BINDING and whatever he/she says goes. It is one and done, therefore, it had better be right.
Your answer:
Quote:
... because the FDA did not have any data from the Amarex trials from which to draw conclusions, thus the holds are based on something entirely different in nature than whether or not Amarex was guilty, negligent, at fault, or any other kind of words one wants to use here.
After the process which Cyrus headed over the past year, in obtaining the RAW data from Amarex, then setting up the internal audit committee, with FDA auditors and regulators, then hiring the 4 External FDA Type GCP Auditors, writing and submitting the Investigational Brochure, the 4 other documents which were submitted monthly, then the results of prior trials were validated against the audited data and posted to complete the prior trials. FDA had questions on benefits / risk analysis and now on hiv trial protocol.
Don't you think SA has access to the external auditor's findings and to all the submissions CytoDyn made to the FDA? All of that went to the FDA for the sake of lifting the hold, not for the sake of winning an arbitration.
Back up Arbiters?
Arbiter's decision?
Is their decision Binding even to them?
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