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Posted On: 10/01/2022 9:20:20 PM
Post# of 148892
Re: Buddyboy20 #129175
Thank you Buddyboy. Yes, this topic is interesting.
I don't see how the current data set could be negligent as it is currently being aggregated into the appropriate FDA approved format. That was the document that was prepared in September, with the remaining series of document to be prepared and sent to the FDA as quickly as they can as per Cyrus.
In previous conference call, Scott Kelly said, I want you to be clear, we have the data, it is just not in the right format.
So for 6 months, Recknor and company have been going through the Amarex trials and aggregating the data into the FDA approved format, on excel sheets instead of paper, etc...
Once the FDA receives all the documents in the series, they will go through the complete aggregation of all the safety data on leronlimab across all the trials that Amarex did and then a determination as to how safe leronlimab will be made based on this work and then the hold will be lifted. I'm thinking Thanksgiving and I believe Emmitt was thinking the same, but I could be wrong.
Certainly, if leronlimab is not shown to be safe by the re-aggregated data, the hold won't be lifted and the BLA would subsequently not be re-submitted, but that won't happen.
The GCP Audit will show that had Amarex done what they were contracted to do, to prepare and submit an acceptable BLA to the FDA, then the FDA would have accepted the BLA and subsequently, leronlimab would have likely been approved by the FDA.
With this positive result, CytoDyn will decide to re-assemble the BLA and re-submit the BLA for HIV by end of year.
I'm not sure how Rantes is getting dollar values from any of this though.
I don't see how the current data set could be negligent as it is currently being aggregated into the appropriate FDA approved format. That was the document that was prepared in September, with the remaining series of document to be prepared and sent to the FDA as quickly as they can as per Cyrus.
In previous conference call, Scott Kelly said, I want you to be clear, we have the data, it is just not in the right format.
So for 6 months, Recknor and company have been going through the Amarex trials and aggregating the data into the FDA approved format, on excel sheets instead of paper, etc...
Once the FDA receives all the documents in the series, they will go through the complete aggregation of all the safety data on leronlimab across all the trials that Amarex did and then a determination as to how safe leronlimab will be made based on this work and then the hold will be lifted. I'm thinking Thanksgiving and I believe Emmitt was thinking the same, but I could be wrong.
Certainly, if leronlimab is not shown to be safe by the re-aggregated data, the hold won't be lifted and the BLA would subsequently not be re-submitted, but that won't happen.
The GCP Audit will show that had Amarex done what they were contracted to do, to prepare and submit an acceptable BLA to the FDA, then the FDA would have accepted the BLA and subsequently, leronlimab would have likely been approved by the FDA.
With this positive result, CytoDyn will decide to re-assemble the BLA and re-submit the BLA for HIV by end of year.
I'm not sure how Rantes is getting dollar values from any of this though.
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