Absolutely no chance. If results are bad we know how they get handled here.
If results are good Leo will not allow anything to compromise the integrity of the trial. Silent and steady right to EUA is the best policy. The FDA expressed their displeasure with CYDY's behavior.
I believe you are on the right path. The normal course would be to wait until all the data is completely reviewed,but these are not normal times, here or abroad.
According to the CDC 438 individuals died from Covid last week in the US. 50% of the population is vaccinated,but the vaccination rates are dropping sharply. Tens of thousands are dying abroad.
I think the Remdeivir model and timeline still applies since another Covid antiviral has not been approved and additional experience with Remdesivir has not confirmed the early enthusiasm.
Remdesivir was given on a compassionate use basis at the very beginning of the US infections in January 2020. This is before any of the clinical trials were finished, but based on studies done for Ebola, SARS and MERs.
In March of 2020 Gilead began an expanded compassionate use program. The first Redesivir Covid 19 trial was begun in China , but suspended. The adaptive phase 2-3 trial was begun on 2/21/2020 and first results posted on 9/25/2020 EUA was granted on May 1,2020 and approval by the FDA was given on 10/25/2020.
IMO that gives a timeline on how Brilacidin may progress.
If the phase 2 Brilacidin trial is very positive. I believe expanded compassionate use could be begin soon. To be quickly followed by an announcement of a phase 3 study with grants and possible partnership. If the phase 3 study shows promise at the first interim report we could see an EUA. Formal FDA approval would be given after the phase 3 trial is completed.
If the phase 2 trial shows modest results, ie better than Remdesivir, we could still see the course accelerated.
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