Maybe your mad bashing of the company confused me as to why you would be complaining and bashing your own investment. As for you and Closetinvestor thinking that there is no point in the continuing of the open label of CD-12. You would be incorrect. Right from the end of the trial this information has been flowing to us through conference calls and webinars. I didn’t make this stuff up. How you missed it I don’t know. It’s not a secret.
As for the last CC. Grow didn’t quite grab all the information and to his/her credit it was stated that this is NOT a transcript. There was one important fact that was missed in the notes that I quoted and if you care enough you can go find and listen.
It was stated that the MHRA WOULD ACCEPT the results of the open label extension and he was not sure the USA FDA would but hoped they would because they extended the open label or something really close to that and I am paraphrasing. Nader has not danced around that comment before. That surprised me. It was stated when the open label was approved by the FDA that the extension could be added and most likely be used to extend the 62 person critical end of our CD-12 trial. It was stated this would be the quickest path to EUA not just once but on a few occasions. Clearly 62 people wasn’t good enough for immediate EUA for the FDA. We hoped but as you can tell by now that hasn’t happened.
I don’t know what to say to the both of you. All I can really say is you need to pay closer attention to what is said. I didn’t make up one fact and clearly only stated what was previously stated. As for you downing Nader speak... don’t even go there... I have been around for long enough to know that not everything pursued is going to happen. But when the CEO has continuously stated the same objective multiple times... I tend to listen a little closer to the updates of this information to see how it is panning out and if the possibility of a quick EUA is still possible. I don’t have any advice for you to grasp the information that has been clearly stated on every occasion since the unblinding of the CD-12 and the approved open label. Maybe turn the volume up?
You have to understand if your sitting in Cytodyn’s shoes... you would not want an open label unless it had benefit to the approval process. Helping people get Leronlimab is very important but any time missed on trials continuing with efficacy is detrimental to helping the world get Leronlimab. Quickly filling another trial would be the priority but that too has not happened. My thoughts on that are that this is way more important than everyone is thinking and the open label becomes our ace in the hole to EUA. That’s my hope and I have put this forward on a few posts. Yet nobody showed interest.
Hearing the updates to this open label process and hearing before we had patients in the open label extension. That not only the MHRA would accept the data but multiple countries would accept the open label data because it follows our trial protocol is something that opened my eyes to this possibility. I believe Canada was mentioned also as accepting the open label data. I guess the big wait is getting enough patients to analyze the data. It was predicted before the open label started that only 70 people would be needed to improve our numbers to get the EUA.
I am done trying to help those who choose not to pay attention to this and will not post another thing about the CD-12 open label extension. I will follow it and see where it goes. Hopefully that is our first EUA either here in the USA or in the UK. But the possibilities are very real somewhere will accept the open label data and our first EUA will happen from the data we analyze. Why? Because the 62 patients were clearly not enough data.
Go CYDY!!!
Let’s help the world!
As for the last CC. Grow didn’t quite grab all the information and to his/her credit it was stated that this is NOT a transcript. There was one important fact that was missed in the notes that I quoted and if you care enough you can go find and listen.
It was stated that the MHRA WOULD ACCEPT the results of the open label extension and he was not sure the USA FDA would but hoped they would because they extended the open label or something really close to that and I am paraphrasing. Nader has not danced around that comment before. That surprised me. It was stated when the open label was approved by the FDA that the extension could be added and most likely be used to extend the 62 person critical end of our CD-12 trial. It was stated this would be the quickest path to EUA not just once but on a few occasions. Clearly 62 people wasn’t good enough for immediate EUA for the FDA. We hoped but as you can tell by now that hasn’t happened.
I don’t know what to say to the both of you. All I can really say is you need to pay closer attention to what is said. I didn’t make up one fact and clearly only stated what was previously stated. As for you downing Nader speak... don’t even go there... I have been around for long enough to know that not everything pursued is going to happen. But when the CEO has continuously stated the same objective multiple times... I tend to listen a little closer to the updates of this information to see how it is panning out and if the possibility of a quick EUA is still possible. I don’t have any advice for you to grasp the information that has been clearly stated on every occasion since the unblinding of the CD-12 and the approved open label. Maybe turn the volume up?
You have to understand if your sitting in Cytodyn’s shoes... you would not want an open label unless it had benefit to the approval process. Helping people get Leronlimab is very important but any time missed on trials continuing with efficacy is detrimental to helping the world get Leronlimab. Quickly filling another trial would be the priority but that too has not happened. My thoughts on that are that this is way more important than everyone is thinking and the open label becomes our ace in the hole to EUA. That’s my hope and I have put this forward on a few posts. Yet nobody showed interest.
Hearing the updates to this open label process and hearing before we had patients in the open label extension. That not only the MHRA would accept the data but multiple countries would accept the open label data because it follows our trial protocol is something that opened my eyes to this possibility. I believe Canada was mentioned also as accepting the open label data. I guess the big wait is getting enough patients to analyze the data. It was predicted before the open label started that only 70 people would be needed to improve our numbers to get the EUA.
I am done trying to help those who choose not to pay attention to this and will not post another thing about the CD-12 open label extension. I will follow it and see where it goes. Hopefully that is our first EUA either here in the USA or in the UK. But the possibilities are very real somewhere will accept the open label data and our first EUA will happen from the data we analyze. Why? Because the 62 patients were clearly not enough data.
Go CYDY!!!
Let’s help the world!
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