Downs have been tough. Not being selected for the Priority Review Voucher for Chagas Disease. Initially denied relisting on NASDAQ (they didn't follow their own procedure). The constant share price manipulation. The virtually paused trial enrollment so that patients by the thousands could get enrolled in other Big Pharma-sponsored trials. And then NASDAQ struck again with such a long delay before deciding to list us again. Then, an inferior mAb gets EUA approval, even though the FDA had our superior efficacy results in hand. And another 104 day long delay before the FDA declined our approval.
But I have always been impressed by Dale's design and management of our share structure, as well as his design and management of our evolved adaptive trial design. And despite our currently unapproved EUA, I credit Durrant with all of his product validation experience with what will be our favorable regulatory decision. And I'm sure it has not been easy for Tim to manage our cash flow, yet keep us in CMC compliance and prepared for commercialization. Perhaps not as well prepared as we had hoped, but ready to start that all-important revenue stream, which I think is basically forcing the FDA's hand to approve us, or answer to HHS and DOD as to why all of our lenz is being sold overseas.
Plus, since before Covid supposedly struck, I watched my wife's disease progression, all the while reading what lenz was accomplishing in making improvements that I'm sure would have helped my wife at each step of the progression. So I firmly believe in lenzilumab's method of action, and that it is not likely that our science can be improved upon.
Look at how right management has been, and for how long they have been right. They have ALWAYS advocated for the concurrent use of remdesivir and dexamethasone, despite negative findings of those drugs, such as by the World Health Organization.
They knew we would likely not show stat sig on mortality with such a small trial, and took heat for adapting our trial to show a successful SWOV outcome.
Despite a longer than expected approval, the company has managed to keep our OS very close to the level they anticipated in 2018. It's really just incredible that a small, independent biotech could come this far with such respect for shareholder value.
This company is going to go into the history books for its success, despite US regulators if need be. I hope I will always have Humanigen shares.
