great follow on news....
After looking back at the Nov 2014 Vanderbuilt animal model data, and Decembers initial human trial data....I really really like the story that today's trial data tells.
In the Vanderbuilt Animal models , the most compelling takeaways were the significant reduction of Fibrosis, and the resulting partial restoration of the mice's pancreatic function. Both of which were proven post mortem thru autopsy. Fortunately non of the Human trial patients died! ....so there was no post mortem organ exams... but the animal model end game results were preceeded by statistically signficant reductions in the stated novel bio markers.
The fact that the HUMAN trial data is paralleling the reductions seen in the animal model, which ultimately led to the extraordinarilly good anti fibrotic and organ restoration in mice... is extremely compelling. It just is. It clearly proves pharmacoligical activity in humans. The fact that they have observed statistically significant decreases in an 11 patient sample, and done it with a sub-optimal dose is phenomenal.
Looking back at the initial Human trial data, and realizing the average 1% HbA1c reductions from 4050 were achieved in patients that were already on a stable dose of existing anti diabetic drugs is impressive. If I understand correctly, had PLI used the same enrollment criteria as the other pharmas did for their diabetes drugs... where they only enrolled patients with HbA1c value at screen of > 7.5%, then the 4050 DECREASE would be approx %1.2 vs the .6% achieved by the industry drugs !! THAT GETS MY ATTENTION... and will get the industry's attention.
Yes PLI ran up big into this news for a variety of reasons. You can certainly argue that the broader market is running into overhead resistance, as is PLI approaching all time highs.... so no surprise the hot money is moving on.... but make no mistake. we are going higher.