After the clinical team’s further analysis the Company will now be submitting to the FDA the Study’s amended protocol with a new primary efficacy endpoint, specifically, assessing the difference in the proportion of participants with improvement in at least two COVID-19 related clinical symptoms on or before Day 14 compared with baseline between Bucillamine versus placebo.
Totally understand bmt's take and he is correct imo, IF, this ep was developed sans fda input, in that the symptoms shown to be resolved by buccy are the least consequential in relation to disease progression and patient recovery.
However, if this was a jointly agreed upon proposal between revive and the fda, or was the path directed by the fda.....well my friends, "THE BAR", set by merck has just been eviscerated!!!
Meaning even if buccy shows clinical efficacy in two of the least detrimental covid symptoms, we are golden since it was the fda that proposed this standard.
Lets hope this is absolutely the case, but im still very confident there will be evidence of efficacy either way.
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