In the Word of the Marathon man Is it Safe?

If you have seen Marathon Man (the film) you will know the scene of "Is it safe". So on the way to emergeny dentist this morning it sprang to mind.

Cladribine failed with the regulators based on safety issues
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                                                 MS Drug                     Cladribine
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PML                                     Natalizumab :1:50-100  Not reported
                                             Fingolimod       Yes
                                             Tecfidera          Yes
                                             anti-CD20         Yes

Secondary Autoimmunities Alemtuzumab  50%        Not Reported
                                             HSCT              10%

Grade 3/4 Lymphopaenia    Alemtuzumab  >95%            25%

Malignancies in Trials         Ocrelizumab 8 verses 0      3 verses 0
 (verse placebo)                   Not different compared to other DMT
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Given their recent track records of approvals, would the regulators be accused of bias if they continue to reject access



CoI: None. ProfG PI on CLARITY study.

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