Ann: PARADIGM RECEIVES FEEDBACK FROM US FDA ON IND SUBMISSION, page-188

Investors also need to remember that the extension study 006 that will treat 750 patients is also

“designed to provide additional information to enhance our label. Such as demonstrating the duration of treatment effect, the responses to retreat meant with PPS and evaluate for BIOMARKER assessments either by Radiograph or Chemicalbiomarkers to determine whether or not disease modifying effects can be demonstrated.” DonnaSkerrett.

So while the 60 patients enrolled in 008 with 50% placebo seems small we need to remember that from a labelling point of view, post phase 3 approval, there will be other supporting data to present to the FDA regarding Zilosul being labelled DMOAD.

008 is a smaller and more nimble study to allow for TGA provisional approval and may also be sufficient to apply for Fast Track designation towards the end of next year.

DYOR and Not advice.