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Posted On: 10/17/2020 1:34:49 PM
Post# of 149265
If Cytodyn gets an EUA Leronlimab becomes the new SOC, right? That fact should carry Leronlimab and Cytodyn wherever they want to go. But if for some reason we don't get EUA, why can't Cytodyn demand help with accelerated enrollment in Phase 3 trials?
As soon as full enrollment occurs, the end of the trial would be just 28 days out. Of course it would take time to collect the data and submit the top line report to the FDA but all the games and half-measures would stop.
Our research is done, in my opinion, and now we are just jumping through hoops. We don't need to relate to anything like the ACTIV trials - we just need to send them our data and ask them why we aren't approved yet!
Help with full enrollment in Phase 3 is the least we should get from the gov't at this point. Can't we even get that if they balk at giving us EUA? This would be a huge ethical failure and there should be consequences!
As soon as full enrollment occurs, the end of the trial would be just 28 days out. Of course it would take time to collect the data and submit the top line report to the FDA but all the games and half-measures would stop.
Our research is done, in my opinion, and now we are just jumping through hoops. We don't need to relate to anything like the ACTIV trials - we just need to send them our data and ask them why we aren't approved yet!
Help with full enrollment in Phase 3 is the least we should get from the gov't at this point. Can't we even get that if they balk at giving us EUA? This would be a huge ethical failure and there should be consequences!
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