"And we know that survival has been correlated with vital capacity. It is a measure. And, unfortunately, unlike cardiology where they have the echocardiogram to look at heart function, as a neurologist treating ALS, we don’t really have objective measures. So we use the vital capacity as one of our objective measures in clinics to measure disease progression and help to give prognosis to our patients. It also is a measure that reflects diaphragm dysfunction, and of course in practice parameters that are published for ALS treatment, we use the vital capacity to make some vital clinical decisions for our patients."
Would you take an experimental drug to live a little longer? It would not surprise me to see Tira get FDA approval on fast track under the condition CYTK does a mortality trial post commercialization. Mortality benefits outweigh tolerability issues. Like a flush beats a pair. GLTA
And about Omecamtiv P3:
"Omecamtiv has been the subject of a study called ATOMIC, a Phase IIb study of this cardiac muscle activator in acutely ill decompensated hospitalized heart failure patients. That study read out results last year, 2013, that we believe support the progression to Phase III. We’ve also recently conducted an additional Phase I study and are now conducting an additional Phase II study, called COSMIC, each with oral forms of omecamtiv mecarbil.
We and Amgen have selected one oral form. We’re proceeding with that one oral form in an ongoing Phase II study called COSMIC, the goal to complete enrollment in that study this year and have that program be teed up to move into Phase III to occur next year. "
Michael. Ever breath through a real straw? Sometimes grasping for straws is realizing the secondary endpoint was exploratory. I see it a lot in CV trials. Mortality or MI's is too risky to have as a primary endpoint, so it is combined or listed as secondary or tertiary. To be studied later if good. it's too sky to have as a primary endpoint, but worth perusing if results are good. You are right OM is always still there.