Provention Bio, Inc. (PRVB)

[north40000]

“..the next big one...”? There is plenty to think about on that question, including a shortened meeting agenda and a majority vote of AdCom recommending approval. A further lengthy clinical trial with more patients is possible, perhaps a Phase 4 confirmation trial after approval. Death of 3 patients in the treatment arm is worrisome. I haven’t read the briefing documents yet, nor have I seen a transcript of the AdCom proceedings.

Anent T1-D, you may find interesting some data and literature that was posted in message # 117234 on the AMRN message board. The Reduce-It trial did not include enough T1-D patients to enable a firm conclusion whether EPA in FDA-approved Vascepa is useful in preventing or treating T1-D.