Correct me if I’m remembering wrong, but one cli
Post# of 153888
(Total Views: 584)
Posted On: 06/20/2023 7:37:50 AM
Correct me if I’m remembering wrong, but one clinical hold was for the USA hiv combo trial, the other was self inflicted for the trial in Brazil. Either way, the safety arm of the hiv combo trial was already filed with the fda, it used not just data from the combo trial, but also data from the investigational trial.
I think, I don’t know, that he reason for the hold was because the integrity of that data was not supported in the clinical submissions so the fda wanted the safety data to be verified before any further trials would continue. I think it horrible that Cytodyn already had the approval of the safety arm and screwed it up in with poor reporting and formatting of the clinical. I don’t think leronlimab is not safe, it was just sloppy work by Amarex that pulled away a section that was approved already.
I don’t think the fda was involved with a conspiracy to suppress the progress, they just want the data to support the results. You can’t just do a trail, have no side effects and call the drug safe. They have to show why and a ton of data about the trial participants to show they represented a good cross section. Amarex did not collect the depth of data to support the initial safety data when it was necessary for the clinical. The fda by far wants to know the labeling of an approved drug has all the side effects listed. Just because a drug has virtually no side effects does not make it easier to approve.
The clinical hold is only on hiv combo and the Brazil hold is on Covid. These are only important because this safety data was to be used for all future indication trial protocols. You could not ask for a bigger CRO screw up than to have this happen. I only hope the data exits enough to get a safe approval good enough for new trials and to restore the integrity of past trials. I can only assume the request from the fda for a new hiv protocol is to see how this safety data will be used ina trial to make sure the data i sufficient. Just having safety data is not enough when they don’t show what will be built on it. The safety data must be complete and all details documented.
I think Cytodyn did try and fill in the blanks previously to make it good enough, but the need for the future is to know it can be used to form new protocols. You can’t write a protocol with assumptions that are not supported.
A future parter is not going to partner if they don’t know what the big new trial will be, if it needs a safety arm, that is a big different animal. I don’t think it will but until the fda says so, we wait for all the future plans.
I think, I don’t know, that he reason for the hold was because the integrity of that data was not supported in the clinical submissions so the fda wanted the safety data to be verified before any further trials would continue. I think it horrible that Cytodyn already had the approval of the safety arm and screwed it up in with poor reporting and formatting of the clinical. I don’t think leronlimab is not safe, it was just sloppy work by Amarex that pulled away a section that was approved already.
I don’t think the fda was involved with a conspiracy to suppress the progress, they just want the data to support the results. You can’t just do a trail, have no side effects and call the drug safe. They have to show why and a ton of data about the trial participants to show they represented a good cross section. Amarex did not collect the depth of data to support the initial safety data when it was necessary for the clinical. The fda by far wants to know the labeling of an approved drug has all the side effects listed. Just because a drug has virtually no side effects does not make it easier to approve.
The clinical hold is only on hiv combo and the Brazil hold is on Covid. These are only important because this safety data was to be used for all future indication trial protocols. You could not ask for a bigger CRO screw up than to have this happen. I only hope the data exits enough to get a safe approval good enough for new trials and to restore the integrity of past trials. I can only assume the request from the fda for a new hiv protocol is to see how this safety data will be used ina trial to make sure the data i sufficient. Just having safety data is not enough when they don’t show what will be built on it. The safety data must be complete and all details documented.
I think Cytodyn did try and fill in the blanks previously to make it good enough, but the need for the future is to know it can be used to form new protocols. You can’t write a protocol with assumptions that are not supported.
A future parter is not going to partner if they don’t know what the big new trial will be, if it needs a safety arm, that is a big different animal. I don’t think it will but until the fda says so, we wait for all the future plans.
(14)
(0)