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Re: DewDiligence post# 292

Monday, 10/08/2018 10:01:36 AM

Monday, October 08, 2018 10:01:36 AM

Post# of 426
PDUFA date for NVS’ BAF312 in SPMS—>Mar 2019 (with priority review voucher):

https://globenewswire.com/news-release/2018/10/08/1617727/0/en/Novartis-announces-FDA-and-EMA-filing-acceptance-of-siponimod-the-first-and-only-drug-shown-to-meaningfully-delay-disability-progression-in-typical-SPMS-patients.html

In the EU, an MAA has been submitted, and regulatory action is expected in late 2019.

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