(Total Views: 521)
Posted On: 10/20/2020 1:04:27 PM
Post# of 153903
I know you are an optimist 
I have seen your posts for quite some time and appreciate them greatly.
I only mentioned it as my first reaction to the last two PRs (excluding the revised time one) has been for my heart to sink and to immediately start stressing about how much effort it will take to get to full enrollment (I appreciated blafarm's post but it didn't paint the rosiest picture with enrollment rates).
But I have had to catch myself both times and remind myself that the DSMC is not the FDA. CytoDyn may still have options open with the FDA especially if they have good data to share with them from the interim analysis. Similar to what happened with the m2m trial, they are likely asking the FDA right now if they will consider certain paths. We have not heard the result of those discussions.
Second, as you point out, there are other paths with other regulatory agencies as well.
Let's hope we get some good news this afternoon. I want to know if they have what they need to give all these entities that have been waiting on these interim results. If so, we will hopefully have some catalysts in the short term.
I have seen your posts for quite some time and appreciate them greatly. I only mentioned it as my first reaction to the last two PRs (excluding the revised time one) has been for my heart to sink and to immediately start stressing about how much effort it will take to get to full enrollment (I appreciated blafarm's post but it didn't paint the rosiest picture with enrollment rates).
But I have had to catch myself both times and remind myself that the DSMC is not the FDA. CytoDyn may still have options open with the FDA especially if they have good data to share with them from the interim analysis. Similar to what happened with the m2m trial, they are likely asking the FDA right now if they will consider certain paths. We have not heard the result of those discussions.
Second, as you point out, there are other paths with other regulatory agencies as well.
Let's hope we get some good news this afternoon. I want to know if they have what they need to give all these entities that have been waiting on these interim results. If so, we will hopefully have some catalysts in the short term.
(4)
(0)
