While this is certainly up to Novartis as far as official releases go, I'm encouraged by the fact that it's an open trial. Patients in the trial aren't prevented from discussing the treatment.
The Doctor running the trial has no doubt either worked with, or for, GNVC, as he's been involved for many years. Novartis partnered the drug just a few years ago.
As for the first patient seeing benefits, remember, he's getting the lowest dosage in an escalating dose trial. I believe a few patients will get each dosage level, so it could be awhile before the dose is high enough to see, or maximize the benefit. Of course no one knows, it may be that even at the lowest dose some benefit is found to exist. Time will tell.
Remember, this already is stated to be a Phase I/II Trial. That designation should mean that first they'll escalate the dosage. Then, when they've determined the most effective dose, several patients will be dosed at that level. I believe we'll know what progress they're making as they escalate if they have patients that clearly see a benefit.
The question in the future may be, could the FDA approve the drug early in development because the benefit is clear, and because no patients in the trial have seen unacceptable side effects. This is doubtful, but not impossible. Approval, subject to a Phase IV, where virtually all patient outcomes are reported for a period of time, is one possibility the FDA could explore.
Gary
