I start this with the codicil that I do not have a
Post# of 81808
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Posted On: 02/23/2021 12:06:17 PM
I start this with the codicil that I do not have a true medical background although I was COO equivalent for an international medical service. I have participated in many many serious negotiations and have been a part of changes of administrations. I was unsettled a bit by the lack of specific data in the PR. So I opine this as a possible explanation.
Cytodyn gets the data from the trial a week to 10 days ago. Perhaps Not a grand slam but a good solid double/triple. eINDS and OLE can go on until decision is made.
They start to submit data to FDA and learn from their FDA liaison that the new administration is putting greater emphasis on therapeutics but is reviewing procedures so as not to duplicate the previous administration s remdesivir fiasco. (Turning around major policy in one month is lightning fast for a bureaucracy.)
So Cytodyn hears there is a new standard of therapeutics results after 60 days. Will they apply the new rules to us? Our protocol was approved. FDA says we are sorry but this is in the country’s interest. Negotiations ensue, can we submit 24 day info, how about 42 day info. Etc.
Then we have Canada and UK and others. What will they do? Will they approve based on 24 days. We know that those countries are informed of the change. Cytodyn has to negotiate with each entity. Not knowing what will apply Cydy gives us one tidbit of information, results are unblinded, but the rest of PR is bland with maybe a touch of frustration. since the ground rules may have changed Cydy says nothing more so as not to prejudice relations.
How many of you have heard spokespersons announce after bilateral talks that ‘negotiations were frank and candid with some progress being made’. Yeah that is a standard formula.
Cytodyn gets the data from the trial a week to 10 days ago. Perhaps Not a grand slam but a good solid double/triple. eINDS and OLE can go on until decision is made.
They start to submit data to FDA and learn from their FDA liaison that the new administration is putting greater emphasis on therapeutics but is reviewing procedures so as not to duplicate the previous administration s remdesivir fiasco. (Turning around major policy in one month is lightning fast for a bureaucracy.)
So Cytodyn hears there is a new standard of therapeutics results after 60 days. Will they apply the new rules to us? Our protocol was approved. FDA says we are sorry but this is in the country’s interest. Negotiations ensue, can we submit 24 day info, how about 42 day info. Etc.
Then we have Canada and UK and others. What will they do? Will they approve based on 24 days. We know that those countries are informed of the change. Cytodyn has to negotiate with each entity. Not knowing what will apply Cydy gives us one tidbit of information, results are unblinded, but the rest of PR is bland with maybe a touch of frustration. since the ground rules may have changed Cydy says nothing more so as not to prejudice relations.
How many of you have heard spokespersons announce after bilateral talks that ‘negotiations were frank and candid with some progress being made’. Yeah that is a standard formula.
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