Missling didn’t seem frustrated at all. I actually don’t believe the fda or its guidances were a part of the delay. He said that he took a step back when several BPs began to fail/fold up their trials last year, causing him to hire Illumina. That explains the delay for all the trials.
He couldn’t start without the new Illumina data. If he came out and said that at the end of last year, he would have been criticized for more data mining. The share price would have taken a hit as a result. And if the Illumina data came up short, it would have been devastating. They did say they were adding the extra testing but didn’t give the reason why. The street speculated it as data mining anyway and took his continued silence along with it as uncertainty. Which it was at that time.
He said, (paraphrasing) when he saw the Illumina data it was a relief. Like something was lifted off his shoulder. At this point, I believe it was a confidence booster, reassuring him of increased chances of success. In hindsight, I can understand the silence. Us speculating is much better than the CEO coming out and saying. “Listen guys, we are delaying our trials to get some more data.” That would have sounded terrible.
So after they got the data, the back and forth began with the FDA. This back and forth is good and will pay off. Everyone wants to get this DONE RIGHT and the FDA is not an obstacle to our success. Probably quite the opposite. Being dynamic and being able to change as things change around you is a quality everyone wants in a CEO. Causing a delay and knowing you will most likely frustrate shareholders for the greater good takes courage. Much better than a stubborn CEO who wants to march forward and meet timelines regardless of what is happening around him. Spending an extra couple of months to do it the smart way is better without a doubt.
So here we are and this time it’s for real. I for one am happy we delayed the trials. When you rush, you get sloppy and no one wins.
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