We're almost 60 days since we hit 195 and just got
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Posted On: 10/22/2020 5:28:11 PM
Re: Riztheinvestor #62760
We're almost 60 days since we hit 195 and just got the recommendation of the DSMC. This time we have to add an additional 14 days from the enrollment goal to present data on 42 day survival, so that puts you at 74 days . Seventy-four days from today is January 6, 2021. So the question becomes, how quickly can we enroll another 63. We know that we have some new sites coming online (good), but there is also a belief that another therapy is going to get approval (not good for us), which Dr. J talked about being a problem (noted by fosalex). We have enrolled 35 in the last 60 days (WTF?), so it's anyone's guess, but we have been behind timelines in every endeavor that has been on Cytodyn's board forever. Two months from today would be an improvement, and that puts us into March.
The DSMC request for another interim look is EXTREMELY COMPELLING, but I just don't have any confidence that we can even reach that point before multiple therapeutics are out there, even though it is quite likely that LL is more effective.
The idea of unblinding is one I really wrestle with. We don't have much to take to these other countries right now without it. As one fellow investor- very long- said to me yesterday, "I think we'll get approved to treat COVID at some point, but the dream of immediate approval and having Leronlimab come in and save the world is effectively gone." If we're the 5th one to the market with a vaccine out there, COVID revenue won't amount to much.
The DSMC request for another interim look is EXTREMELY COMPELLING, but I just don't have any confidence that we can even reach that point before multiple therapeutics are out there, even though it is quite likely that LL is more effective.
The idea of unblinding is one I really wrestle with. We don't have much to take to these other countries right now without it. As one fellow investor- very long- said to me yesterday, "I think we'll get approved to treat COVID at some point, but the dream of immediate approval and having Leronlimab come in and save the world is effectively gone." If we're the 5th one to the market with a vaccine out there, COVID revenue won't amount to much.
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