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Thursday, December 31, 2020 10:38:46 AM
I am seeing caution by the CEO. Some can call it hiding, however after we heard about the failed premature grant submitted in collaboration with GMU, I think that was a sign to be prepared. Just cause you have what might be a Covid miracle drug doesn't mean the FDA/NIH/Barda are going to support you
I think Leo was prepared, and have heard supporting comments to this effect, to start trials this Q. It seems every blue moon someone on this board has info about delays. Recently I read about RBL internal delays that were unknown to me (and I am sure most everyone else here). It could be a lie, but it could also be true. We just don't know
I assume someone will come out after the trial starts and say the company had to overcome logistical delays... whether it was wrong paperwork or just blame it on the holiday schedule (which some of us were cautious about in Oct/Nov to begin with)
There will be a trial. There will be interim results. I believe we need to have greater results then Remdesivir first displayed
https://www.nih.gov/news-events/news-releases/nih-clinical-trial-shows-remdesivir-accelerates-recovery-advanced-covid-19
Preliminary results indicate that patients who received remdesivir had a 31% faster time to recovery than those who received placebo (p<0.001). Specifically, the median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo. Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group (p=0.059)....Recovery in this study was defined as being well enough for hospital discharge or returning to normal activity level....
and our primary endpoint:
The trial’s primary endpoint is time to sustained recovery through Day 29 based on the National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial (ACTT) clinical status ordinal scale.
http://www.ipharminc.com/press-release/2020/12/21/fda-grants-ind-approval-for-phase-2-clinical-trial-of-innovation-pharmaceuticals-brilacidin-for-treating-covid-19
the above is all IMHO (consider this my safe harbor statement)
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