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Message: Re: Opportunity Knocks
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Jul 19, 2019 10:27AM

Great post Paladin. Here is the post 2231042 that Paladin was referring to.

Yes, there are many ways this could play out. Also, there are many milestones/inflection points through 2020 and beyond that could continue to influence the share price and market cap after the intial announcements about the primary and secondary BETonMACE endpoints and the CKD/Cognition sub-studies: 

NDA and MAA filings with FDA and EMA, respectively

Decisions by FDA/EMA to grant priority or standard review

Need or no need for FDA Advisory Committee meeting

NDA and MAA approvals

Specifics about what the NDA/MAA label includes or doesn't include

Details of funding and timeline for already planned/announced trials: Fabry, Pulmonary Arterial Hypertension, Renal and Vascular Cognitive Dementia Trials

Details of other potential follow up trial(s) for cardiovascular, renal and cognitive diseases to expand label & patient population beyond the low-HDL, T2D with recent ACS patients in BETonMACE

 

 

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Jul 19, 2019 11:31PM
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Jul 20, 2019 08:18AM
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