Purchase Summary

In order to access content on the FENIX Marketplace, you must have an account. You will also have access to FENIX Free updates.

The price for access is $599.00.

Account Information Already have an account? Log in here

LEAVE THIS BLANK

Payment Information We accept all major credit cards

By selecting this, I agree to receive emails from fenix.group.

You will be redirected to view the full article after purchasing. You will receive your account and payment information in a confirmation email, and can be viewed at any time in your Account.
RETURN TO HOME
$599
Other

Teplizumab Adcom: 10-7 Split Vote; Questions Raised on Teplizumab's Approvability

Here is a brief preview of this blast: Today, FDA held an advisory committee meeting to discuss the proposed teplizumab indication to delay the onset of T1DM based on results from the TN-10 study. The panel narrowly voted in favor (10-7) that the teplizumab benefits outweigh the risks. Recall, ahead of the adcom, FENIX correctly predicted a 10-7 vote favoring teplizumab. Below, FENIX provides a summary of key adcom panelist commentary as well as thoughts on the vote and next steps for Provention Bio and teplizumab.

About The Author

Matthew Maryniak

|
President of Fenix Group International
Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.