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…
This content is reserved for subscribers. For a limited time only you can use Coupon Code NEWYEAR to receive $395 off an annual subscription. Click here to subscribe.