Jan. 24 at 1:16 AM
$GOSS
I’ve done a deep dive myself. I tend to agree this has a strong chance of stat sig on primary and secondary endpoints.
The lessons learned from the Torrey study ie 1.
1. increase the proportion of functional class 3 patients over FC 2,
2. use a sicker population in a part of the world with less access to health care and stabilizing meds (Latin America predominant instead of US)
3. Standardizing the walking test (wear shorts no flip flops etc)
These changes along with earlier studies showcasing ascending dosage studies to find
5. best dosage with fewest AE and overall minimal adverse events already shown, with additional 72 month open label data showing
6. durable NT-proBNP improvement and Functional Class stabilization (and some improvement).
All this makes a very compelling case for stat sig primary endpoint (I actually think it will be 30 m plus)
TA perspective: broke out, retested 9 EMA, and ready to run
