...We Welcome You To The Resverlogix HUB withIn The AGORACOM COMMUNITY!

Free
Message: EMA

Hey friends, I've been lurking on this board for a couple years mostly without an account and I really appreciate the insights and perspectives shared here over time. Many thanks!

Back when the webcasts came out with BoM data, I understood RVX was applying for accelerated approval programs from the FDA and the EMA, which I believed would be BTS and PRIME respectively. This morning I watched the corporate update and they mentioned the EMA in a bullet point but as far as I can tell we should have heard about PRIME status long ago based on the timeline given by the EMA (https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/prime-eligibility-requests-2020-deadlines-submission-timetable-assessment_en.pdf) and when DM said they were applying for FDA/EMA accelerated approval programs (within 90 days at the end of last year IIRC). Did I miss something or is it safe to assume apabetalone was rejected for PRIME?

If true, bonus points if anybody has opinions on how much that matters...

3
Jun 10, 2020 05:27PM

Jun 11, 2020 04:21PM
Share
New Message
Please login to post a reply