There are a few reasons BTD is so important. Many time a small biotech that has a single indication will need investors to make a big jump from where they are prior to p3 trials to approved drug, which is a huge risk. Investors know the chances of success is very slim and the information is basically coming from the company who wants the investor to believe them at there work, because that is all there is. Is the trials for that indexation don’t go well, the company tends to find some positives from the trials and spin off other indications or specific uses for there drug, which likely is less valuable than the original indexation.

BTD is a way to show that it is not just the company doing a pitch for there drug, the FDA agrees that there is some strong potential. This is a huge risk reduction. Only about half the drugs that get BTD actually get approved, but this is better than drugs that do not have BTD, which is only 9%. Also, drugs that have BTD get to approval faster than not having it so to investors they can see the finish line much clearly.

In the case of leronlimab, the ever expanding list of indications are bigger than the original indexation and the MOA is very supportive that these indications are not just pipe dreams that cytodyn is creating to lure in investors. We have enough data to suggest not pursuing Nash, cancer and other indications would be stupid. This is such a rare situation, it is impossible to find examples like this in the drug development world. BTD is so important to show this is not just us investors and the company, it is the very regulator that ultimately decides if a drug is getting approved feels this is the real stuff.