Thoughts from another board on down price?? Muc
Post# of 148341
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Posted On: 08/12/2020 8:59:22 AM
Thoughts from another board on down price??
Much as I hate to admit, some of the naysayers below are not very wrong...as in the past, the company's write up doesn't appear to be up to snuff...unless what was left out was left out intentionally.
Per the Clinicaltrials.gov site, the primary endpoint is as follows:
“Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) [ Time Frame: Day 14 ]”. But the released results do not reflect this endpoint text verbatim. That strikes me, a medical writer with 20 years of regulatory writing experience, as a bit strange; their language seems to dance around the endpoint text (Day 14 vs. 3 days in results). However, I think the naysayers are wrong in asking for a P-value for this endpoint. The endpoint is CLINICAL IMPROVEMENT; such goals and outcomes need not be statistically significant. If one acheives significance, that's fine and dandy, but they are not expected to. Having said that, what the company did put out is phenomenal - seeing a clinically meaningful difference at Day 3 in MM patients! Man, that is really some achievement! I am hoping that these Day 3 results extend all the way to Day 14. Also, I also didn’t like it very much that they squeezed in subgroup analyses into the paragraph summarizing the primary endpoint...even if these are topline results. One expects some order in presentation.
As far as the key secondary endpoints are concerned, they seem to have left out the very first one - “Time to clinical resolution (TTCR) [ Time Frame: Day 14 ]. This omission also intrigues me.”
Much as I hate to admit, some of the naysayers below are not very wrong...as in the past, the company's write up doesn't appear to be up to snuff...unless what was left out was left out intentionally.
Per the Clinicaltrials.gov site, the primary endpoint is as follows:
“Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) [ Time Frame: Day 14 ]”. But the released results do not reflect this endpoint text verbatim. That strikes me, a medical writer with 20 years of regulatory writing experience, as a bit strange; their language seems to dance around the endpoint text (Day 14 vs. 3 days in results). However, I think the naysayers are wrong in asking for a P-value for this endpoint. The endpoint is CLINICAL IMPROVEMENT; such goals and outcomes need not be statistically significant. If one acheives significance, that's fine and dandy, but they are not expected to. Having said that, what the company did put out is phenomenal - seeing a clinically meaningful difference at Day 3 in MM patients! Man, that is really some achievement! I am hoping that these Day 3 results extend all the way to Day 14. Also, I also didn’t like it very much that they squeezed in subgroup analyses into the paragraph summarizing the primary endpoint...even if these are topline results. One expects some order in presentation.
As far as the key secondary endpoints are concerned, they seem to have left out the very first one - “Time to clinical resolution (TTCR) [ Time Frame: Day 14 ]. This omission also intrigues me.”
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