Ann: BIOTRON DRUG EFFECTIVE AGAINST COVID-19 IN ANIMALS, page-322

How do you know FDA will be funding the trial?

Chances of parternship - that's what you wish. Anything is possible but you simply don't know.

Do you have a proven or safe drug or both? Not proven for anything, as of now.

Very strong evidence is such studies may or may not mean anything. A number of new molecules were beneficial in such studies but came to nothing (either received no funding or failed in human trials). The literature is littered with such molecules. So you are not certain whether it will work or not.

Remdesivir has limited but arguably proven benefit and this molecule has no proven human benefit for this virus.

Now coming to what was reported:

1. For in vitro study, what dosage would you require to get to the EC50 that is enough to inhibit replication
2. In vivo study, the dosage was 100mg/kg and 300mg/kg. Try extrapolating this to a 80kg human. What is your take on extrapolating pharmacokinetics of this mice to humans (absorption, CL, Vd, elimination kinetics etc). Safety data from prior study was on 100-200mg (not mg/kg)
3. Figure 1. Use of T-test for data that does not appear to be normally distributed, skipped SD/SEM/CI altogether
4. CIs do come up in figure 2, but not reported in numerals, SD/SEM missing
5. Same for figure 3. Guess, with n=5, reporting CIs is not in their favour
6. Only WA1 for mice study

As far as the last RCT goes, perform a critical appraisal/check with RoB 2/CONSORT. You will know why there wasn't any taker.

I wish you luck with this molecule and hope that it will not add to growing worldwide frustration with research waste. I am of firm opinion that optimism from vaccines should not deter research funding of therapeutic molecules.

Best, G