RE:RE:RE:RE:RE:History RepeatsQuentin history does repeat itself!!! Let's talk phase 3 experience.
It begins with ONC's head and neck failure. ONC failed the Head and Neck Trial on two counts. First a large group of patients dropped out with flu like symptoms. You know the best responders. Sound familiar. The second reason is in the last 6 months of a 6 year trial they changed design within a dynamic protocol. They broke up the population into sub groups and lost statistical significance. The trial would have succeeded without the protocol change. Per Matt's words.
Then there was the intent to do a phase 3 in bladder cancer. A quick entry to market. But they got scooped on that one.
Then they were close to filing for phase 3 with colorectal. And that got pulled after release of findings on IND213 breast cancer surprised them.
They then hired a top notch chief med officer who put together a phase 3 filing for Breast Cancer. Two years later he was ready to file. ONC then changed coarse and the chief med officer resigned. ONC decided to waist 4 more years on an AWARE study that would help develop predictive markers. And they also wanted an ICI arm.
Bracelet trial was launched and look how that turned out. The ICI arm failed and the predictive marker failed. Note the marker failed because people dropped out of the trial with flu like symptoms...hmmm.
ONCs delays to breast cancer trials allowed entry of competitive ADC technology. Which has caused ONC additional delays and reduced the market potential.
It's a gong show. This companies share price would go to the moon if directors fired Matt and most the staff and brought in a divestiture guy. Matt is incompetent and allergic to running a phase 3.