GD: Can you send me my calculator with your assumptions that generate 10% OAS using the 37% OS for year-5? I have a feeling that you will end up needing a "lightrock resurrection" and I'm not good at conjuring miracles.
You whatever assumptions you employ they MUST result in 63 months-to-endpoint (+/- three months, I'll give you that) in the Kaplan-Meier tab of our calculator. Anything else is imaginary, like the lift generated from a wing in outer space.
Why is there almost year delay reporting results? Is this your concern?
Recall that the trial was stopped for safety concerns in November of 2016. The company wanted to increase the enrollees but after about a year they decided not to. In late 2015 and 2016 the bulk of the trial was enrolled. What was happening? The injections of MK are made adjacent to the tumor(s). Multiple shots. Does anyone know how many? Is there a clinician on this board who is describe this? ...well, potentially scores of shots. AND repeated five times per week for three weeks. This drug is known to cause a significant immune response. So swelling, pain, and potential immune responses far from the injection site. It scared the IDMC enough to stop the trial for almost a year. Think about it. They had very little indication at that time how efficacious MK might be. What they did know looked scary. A year went by. During that period it became apparent that the trial shouldn't be stopped. Why? Probably because the test arm was not dying of the cure. But were they being saved? Saved enough to warrant the pain and risk? Even a superior OAS would not be a good reason to stop this trial. There was no control group sitting in a waiting room taking with the OBVIOUSLY cured test arm while they were dying. No ethical reason to stop. HOWEVER, if this works, and the response isn't related to some obscure and rare biomarker, this drug will go off-label faster than Novartis' Gleevec in 2000. So the IDMC is going to be EXTRA careful before releasing the results AND the FDA is going to do the same. Why? Because everyone is going to try this therapy for everything, even the common cold (OK, maybe not that).
So, GD, If you are genuinely afraid that MK has failed, I'd sure like to understand how you got there. I don't want to ski off that cliff either.
Cheers from a cold clear evening in the Oregon rain forest,
News 
Market Data 
Discover 
