Yesterday, Provention Bio (PRVB) provided an update from the FDA on its drug application for teplizumab.
As I told you to expect, as did management, the approval decision was delayed while the company resolves a drug comparability issue.
Then, a fresh update to the company’s investor presentation in the last 24 hours provided some additional and pertinent information on the topic.
In the end, I remain convinced the drug is on track to ultimately be approved. It’s not a matter of if, just when. As you’ll see in a moment, I believe we now have better clarity on exactly “when” it will happen.
So let’s get to it and the three key takeaways from the FDA delay…