To all the patients out there, and their families and significant others, I have some very good news. We have all been waiting, painfully I know, for the green light to go into clinical trials and today I just got word that the FDA has given us the go ahead to proceed to clinical trials. So, to all of you how have been wondering “how soon?” the answer is now more clearly “soon!”
Please bear in mind that this is just the beginning. Not the beginning of our labors, certainly (which go back decades), but the beginning of the clinical undertaking. The whole project remains experimental, yet all of our hopes are running high. So, while this does not translate immediately into a treatment for all concerned, it opens the door to that possibility. Our work is not done, and your waiting is not over, but this is a really wonderful day and I wanted very much to share it with all of you who have been hanging in there despite what must seem like a glacial, excruciatingly slow process. The reality is that things are moving quite rapidly for a process like this and for that I need to thank all those who have made this happen, in the laboratory, in the generous financial support and as consultants and intermediaries of all stripes.
A big thanks to everyone concerned at this momentous occasion: the completion of the preclinical phase and the beginning of clinical application for this ongoing project.
Henry Klassen, MD, PhD