Copied from Yahoo Board. Has this been discussed h
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Posted On: 03/13/2021 11:05:12 PM
Copied from Yahoo Board. Has this been discussed here?
The FDA has a big problem. By continuing EIND and OLE even after the CD12 data is released, they are admitting that the safety and effectiveness of LL appears to be there. Otherwise, it is the FDA's duty to stop this immediately to save patient lives. The longer the FDA allow OLE and EIND, the harder it will be to stop both again. On what grounds did they run or end OLE and EIND after CD12? Probably can't terminate OLE either if the data is needed for MHRA?
If CD16 starts now, then the problem, which will also be an ethical one, becomes even bigger. With what justification do you let patients get a placebo and meanwhile terminate EIND and OLE to get patients at all? You let patients get LL for a while and now you take it away from them?
Another problem: If CD16 is successful in 2 months, how will the FDA justify their behavior after the fact? How are they going to justify not saving 30% of patients under 65 from death just to get the matching p-value? After the other data of EIND April 2020, CD12 and CD10 also showed improvements of patients and prove the MOA of LL, surely no one believes that CD16 will come out with a worse result?
So the best thing to do is to immediately request an EUA from Cytodyn so that the FDA has to own up to their decisions. Maybe this will also help the FDA to solve their problems
The FDA has a big problem. By continuing EIND and OLE even after the CD12 data is released, they are admitting that the safety and effectiveness of LL appears to be there. Otherwise, it is the FDA's duty to stop this immediately to save patient lives. The longer the FDA allow OLE and EIND, the harder it will be to stop both again. On what grounds did they run or end OLE and EIND after CD12? Probably can't terminate OLE either if the data is needed for MHRA?
If CD16 starts now, then the problem, which will also be an ethical one, becomes even bigger. With what justification do you let patients get a placebo and meanwhile terminate EIND and OLE to get patients at all? You let patients get LL for a while and now you take it away from them?
Another problem: If CD16 is successful in 2 months, how will the FDA justify their behavior after the fact? How are they going to justify not saving 30% of patients under 65 from death just to get the matching p-value? After the other data of EIND April 2020, CD12 and CD10 also showed improvements of patients and prove the MOA of LL, surely no one believes that CD16 will come out with a worse result?
So the best thing to do is to immediately request an EUA from Cytodyn so that the FDA has to own up to their decisions. Maybe this will also help the FDA to solve their problems
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