> I felt good! The next step was in sight: a test of the drug in humans, to see if we actually saw the blood levels of cyclosporine that I expected we would. We had contracted with a CRO in the Netherlands and were raising the $1+ million needed to actually carry out the test when – pop! – the biotech markets imploded. Suddenly, investors literally stopped returning my (and everyone else’s) emails.<p>That sounds like a Phase 1 trial for safety in human volunteers. If the plan was to sell the IP to or partner with a major Pharma, maybe this could work. But the IP situation may not be that clear-cut with a drug repurposing, especially given this:<p>> This is still a tall order for a guy whose background was, again, science blogger. But things went surprisingly ok, all things considered. I linked up with an excellent corporate attorney and patent attorney, both of whom agreed to let me use their services on a pay later basis. ...<p>You really can't do this on the cheap.<p>People in tech (or even science broadly) trying to get into the drug industry frankly have no clue about what it actually takes to get a drug approved for humans in the US. Hundreds of millions are table stakes. The bar is higher than just about any other industry for new product introduction, even for a repurposing.<p>Even if the bear market had stayed in hibernation for another year or two, the fundamental problem is that human drug approval is a massive resource drain that requires very deep pockets and an ironclad IP position.<p>Failure (after massive expenditure) should be considered the base case.