Keep hearing how infections are killing many every day worldwide.
Obviously the current crop of antibiotics can't prevent the really nasty infections from occurring or spreading.
Then here sits B-ABSSSI with a successful P2 and no side effects waiting for $30MM to be able to conduct a P3, a VERY large P3. Why so large?
So maybe USA and Europe are off the grid for current use for infections.
But there are other parts of the world where people are needlessly dying when B may be a solution that could end quite a bit of the suffering and loss.
Why not let those countries that are seeing massive losses be able to buy B at slightly above production costs to try on patients looking for a last gasp remedy for their problem? IPIX doesn't lose money (though they also don't make much), the FDA/EMA get to see if the antibiotic works and if it does they could require a MUCH smaller trial population, some patients will still be living that would not be the case should B not be available, and if B doesn't work in most cases the patients should not be any worse off due to bad side effects as if they never took the antibiotic. If some discernible bad side effect pops up, stop the treatments immediately.
Seems like a very good win to risk ratio to me.
But then what seems logical to me doesn't float in many cases. Are there some risks in this idea, yes, but not taking any risks puts so many patients at VERY HIGH risk of dying from infection. I know this will never fly, but IMO it should be the patients right to determine what risk is acceptable to them.
I know if I had cancer that was terminal I would take any possible treatment as there is nothing to lose.
Obviously the current crop of antibiotics can't prevent the really nasty infections from occurring or spreading.
Then here sits B-ABSSSI with a successful P2 and no side effects waiting for $30MM to be able to conduct a P3, a VERY large P3. Why so large?
So maybe USA and Europe are off the grid for current use for infections.
But there are other parts of the world where people are needlessly dying when B may be a solution that could end quite a bit of the suffering and loss.
Why not let those countries that are seeing massive losses be able to buy B at slightly above production costs to try on patients looking for a last gasp remedy for their problem? IPIX doesn't lose money (though they also don't make much), the FDA/EMA get to see if the antibiotic works and if it does they could require a MUCH smaller trial population, some patients will still be living that would not be the case should B not be available, and if B doesn't work in most cases the patients should not be any worse off due to bad side effects as if they never took the antibiotic. If some discernible bad side effect pops up, stop the treatments immediately.
Seems like a very good win to risk ratio to me.
But then what seems logical to me doesn't float in many cases. Are there some risks in this idea, yes, but not taking any risks puts so many patients at VERY HIGH risk of dying from infection. I know this will never fly, but IMO it should be the patients right to determine what risk is acceptable to them.
I know if I had cancer that was terminal I would take any possible treatment as there is nothing to lose.
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