The key sentence, to me, regarding our success, is as follows.
"Humanigen and SAHMRI are assessing regulatory pathways that may enable early results to support a regulatory submission and potential provisional registration or approval by the Therapeutic Goods Administration in Australia.
The reported results of that trial don't just support a favorable regulatory approval, they DEMAND it.
"Each parameter (blood monocytes, bone marrow blast percentage, platelet count, blood hemoglobin concentration, and spleen size) has exhibited a durable return to normal or near normal values, with statistical significance. Two of the ten participants have been in the trial for 18 months, the longest of any participants, and exhibit lasting improvement. No participants have relapsed. One participant is now a candidate for stem cell transplantation, which may lead to a potential cure in that patient."
Durrant has been telling us since last year that lenzilumab's performance in this trial could be the key that unlocks the door for us, and it's easy to see why he says that.
This isn't the first time I have seen clinical trial investigators express shock and joy at how quickly and effectively lenzilumab has caused patients to recover. I saw and heard the Mayo Clinic investigators express those same sentiments in our LIVE-AIR trial reviews.
A video of LIVE-AIR trial investigators Dr. Temsegen and Dr. Libertin, of Mayo Clinic, should be forwarded to The Therapeutic Goods Administration, as Dr. Thomas' comments regarding improved CMML results, echo the sentiments of the covid treatment doctors.