The problem with this theory is if the pivotal tri
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Posted On: 11/22/2023 4:22:36 PM
Re: Cassandra X #139226
The problem with this theory is if the pivotal trial was ready for approval, why did Cyrus throw in the towel on finishing it up? Seems like what the FDA needed in the BLA was going to take more time and money.
I guess it could be that at the time when it was determined that we are stopping the HIV approval process, that now the discussions with the FDA have changed? Maybe when the FDA saw Cytodyn was giving up they decided to give some sign of light at the end of the tunnel? maybe the KOL meeting got the FDA to try and find a way to get this sorted out?
If that is true, based on the current history of total darkness in communication i doubt Cytodyn would announce a change in course and reverse the statement that they are not pursuing the HIV approval. My guess is that Cytodyn would stay quiet and see what pans out. If the FDA truly does not bend, then they never announced anything other than they gave up on it. If the FDA surprises us, then it is a great surprise.
We really have no idea what it was the independent audits found that made us stop trying at HIV. I don't think Cyrus would give up unless it was a fairly large obstacle that was in front of us. If now that obstacle has a good path around it, i guess it is possible?
I guess it could be that at the time when it was determined that we are stopping the HIV approval process, that now the discussions with the FDA have changed? Maybe when the FDA saw Cytodyn was giving up they decided to give some sign of light at the end of the tunnel? maybe the KOL meeting got the FDA to try and find a way to get this sorted out?
If that is true, based on the current history of total darkness in communication i doubt Cytodyn would announce a change in course and reverse the statement that they are not pursuing the HIV approval. My guess is that Cytodyn would stay quiet and see what pans out. If the FDA truly does not bend, then they never announced anything other than they gave up on it. If the FDA surprises us, then it is a great surprise.
We really have no idea what it was the independent audits found that made us stop trying at HIV. I don't think Cyrus would give up unless it was a fairly large obstacle that was in front of us. If now that obstacle has a good path around it, i guess it is possible?
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