the FDA is completely making stuff up here. VERU g
Post# of 154067
(Total Views: 688)
Posted On: 03/05/2023 9:03:54 PM
the FDA is completely making stuff up here. VERU got hosed for one reason only...it works. SOUNDS FAMILIAR.
why does the FDA go along and say a trial is moving perfectly and millions of dollars are spent, the safety review halts the trial because the efficacy is stellar and its unfair to the placebio patients who are dying, only to come back and say no to EUA or approval based solely on the fact that the trial is inadequate in some way?
THEY APPROVED THE TRIAL
its a set up from the getgo.
how long will they get away with this? not only here but worldwide control? very little happens in other countries that dont get the green light here first. there is nowhere on the planet that can escape the heavy hand of the FDA, or leronlimab would be available in belize or hahahaha phillipines
one of the VERU complaints by the FDA is the trials were in other countries, which i guess cant be trusted.
WHY APPROVE THE TRIALS THEN? - to bankrupt small companies with good drugs
why does the FDA go along and say a trial is moving perfectly and millions of dollars are spent, the safety review halts the trial because the efficacy is stellar and its unfair to the placebio patients who are dying, only to come back and say no to EUA or approval based solely on the fact that the trial is inadequate in some way?
THEY APPROVED THE TRIAL
its a set up from the getgo.
how long will they get away with this? not only here but worldwide control? very little happens in other countries that dont get the green light here first. there is nowhere on the planet that can escape the heavy hand of the FDA, or leronlimab would be available in belize or hahahaha phillipines
one of the VERU complaints by the FDA is the trials were in other countries, which i guess cant be trusted.
WHY APPROVE THE TRIALS THEN? - to bankrupt small companies with good drugs
Quote:
According to the article at link below, the mortality rate was 20.2% (19 of 94) for sabizabulin versus 45.1% (23 of 51) for placebo (SOC). 45% for SOC is high.
The following is from the FDA Briefing Document which is linked in the article:
The FDA Review team acknowledges that Study 902 met its prespecified primary endpoint of all-cause mortality at Day 60. We also note that the VERU-111 program is quite small in size compared to other therapeutic programs for patients hospitalized with COVID-19. As detailed in the briefing document, our review has identified a number of uncertainties with the data, which we raise in the context of this small trial in critically ill patients. These include:
•High placebo group mortality rate
•Potential for unblinding events with enteral tube administration
•Baseline imbalances in standard of care therapies
•Differences in hospitalization duration prior to trial enrollment
•Uncertain effects of goals of care decisions on all-cause mortality
Read More: https://investorshangout.com/post/view?id=654...z7v8elonyF
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