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Dieselpro

03/04/21 2:09 PM

#149906 RE: portage1066 #149903

This doesn't add up at all. If CD12 failed on endpoints why is CD12 recruiting with OLE, and Leronlimab has eIND. So your saying the FDA knows it failed...but is still allowing it to be used??

And to answer your question most longs here are invested in Leronlimab not a reputation. If a person invests in a company because management makes them happy and their drug is questionable, as in needing to change the trial, like hgen for instance, they're setting themselves up for failure.

misiu143

03/04/21 2:11 PM

#149909 RE: portage1066 #149903

Lenzilumab needed to change 3 times primary endpoint during this study......

First they removed mortality , and use length of hospitalization.
At this time for Lenzilumab was about 6 days and otherwise 9,
but as SOC improved , length of hospitalization went down to 7 days , so company needed to change again , since they will not meet the endpoint ..
And of course during interim DSMC advise to add patients if any hope to accomplish positive results ..

Yes I am worry how this study will end up.

Leronlimab , stood with mortality as a primary endpoints , I bilieve the only company finishing study with mortality as a primary endpoint.
during interim , no changes were advise.

NEWS2 results were statistically significant , and first 65 EIND critical patients results were impressive.

I expect very good results from this study..And FDA never talk for few weeks about failing results , this I am sure about..

All IMO.


Emergcy

03/04/21 2:17 PM

#149913 RE: portage1066 #149903

Come on, why such a post? We all have seen in the last few weeks that FDA stopped several trials from well-known companies. Does anyone really believe that FDA would hesitate to send CYDY to hell if the results would be bad?

Pinseekr

03/04/21 2:19 PM

#149914 RE: portage1066 #149903

So a CEO goes into a hole to delay bad results....hmmmm so delaying bad results will help things?? How would he or the company be gaining by not getting the bad news out quickly and pivoting to BLA for HIV. I am thinking the exact opposite of your conclusion of the delay. I could be wrong.