Can you describe your experience treating patients with both active and not-active PPMS, and what your typical plan for treatment looks like?

How does your course of treatment differ for patients who have active PPMS versus those with not-active PPMS? What drugs are currently used and how effective are they? What is done outside of treatment with drugs and how effective are these methods?

Can you discuss the design of the trails for each drug thus far, and what the results are suggesting? 

There are no currently approved treatments for PPMS, but there are several disease-modifying therapies that work by reducing inflammation in the central nervous system. The problem with these treatments is that MS is characterized by nerve degeneration and not inflammation. Can you discuss the mechanism of action of MD1003 and ocrelizumab, and how they differ from current therapies? 

The primary endpoint of MedDay's MS-SPI study was the proportion of patients with either improvement of the Expanded Disability Scale (EDSS) or the timed 25-foot walk (TW25) after nine months and confirmed at 12 months. Can you discuss the validity of this endpoint and others used in this trial and Roche's trials?  

The primary endpoint was met with 12.6% of patients in the MD1003 arm demonstrating a confirmed reversion of progression, compared to zero patients in the placebo group. Is this number clinically relevant, and how does it compare to the results for ocrelizumab thus far? 

In their MS-on study MedDay wanted to see whether MD1003 could improve patients who are progressively becoming more disabled, or decrease recovery time after an incomplete remission of an acute relapse. They failed to meet their primary endpoint. Can you discuss the design and results of this trial, and how it compares to what you've seen from ocrelizumab?

Was there anything else noteworthy in MedDay's recent data release? Can you summarize the safety and efficacy results for both drugs? 

Given the current information, how do you view the chances of approval for MD1003 and for ocrelizumab? 

If MD1003 gets approved in not-active PPMS, will MedDay try to expand their indication into active PPMS? Would it be able to compete with ocrelizumab in active PPMS? 

Assuming both drugs get approved, what percentage of existing not-active PPMS patients will switch to MD1003 and how many will switch to ocrelizumab? What percentage of active PPMS patients would switch to MD1003 and how many would switch to ocrelizumab? What percentage of new PPMS patients do you expect would use each drug?

How safe and effective are current treatment options, and how do MD1003 and ocrelizumab compare?