Multiple Sclerosis Research Repository

Dear FDA:

Please see my analysis of “Center for Drug Evaluation and Research, Application Number: 761053Orig1s000, Medical Review(s)” (Ocrevus/ocrelizumab), and please advise as to how WA25046 (the clinical trial of Ocrevus for PPMS which led to the FDA approving it) was both simultaneously “adequate and well-controlled” and “not adequate and well-controlled.”

Instances where this document says the PPMS trial WAS “adequate and well-controlled” and WAS NOT “adequate and well-controlled” (contradictory!!!)

-From: “Center for Drug Evaluation and Research, Application Number: 761053Orig1s000, Medical Review(s)” (Ocrevus/ocrelizumab)

1. “Trial WA25046 is not well-controlled…” (Cross Discipline Team Leader Review, Benefit-Risk Analysis, p 4)

2. “Dr. Rodichok agrees that it (PPMS trial WA25046) is adequate and well-controlled” (Cross Discipline Team Leader Review, Clinical and Statistical Reviews of Efficacy, 44)

3. “This review concludes that it would be reasonable to decide that the WA25046 trial is not adequate or well-controlled” (Cross Discipline Team Leader Review, Clinical and Statistical Reviews of Efficacy, 45)

4. “-The trial is adequate and well-controlled” (Cross Discipline Team Leader Review, Clinical and Statistical Reviews of Efficacy, 54)

5. Primary progressive MS: A single adequate and well-controlled trial…” (Clinical Review, Benefit-RIsk Summary and Assessment, 18)

6. “In a single adequate and well controlled trial [WA25046]…” (Clinical Review, Benefit-RIsk Summary and Assessment, 22)

1. “…in an adequate and well controlled trial [WA25046]…” ((Clinical Review, Benefit-RIsk Summary and Assessment, 22)

I look forward to your explanation of this impossibility.