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Message: Re: so what happens if dm fumbles the ball??

The purpose of the Comprehensive Multidisciplinary Initial Breakthrough Therapy Designation (BTD) meeting held between the FDA and Resverlogix on June 2, 2020 was to discuss the ongoing development program for apabetalone following receipt of the company’s Breakthrough Therapy Designation announced on February 3, 2020.

“I am extremely pleased with the very constructive BTD discussions with the FDA to-date and look forward to our ongoing work and future progress,” stated Donald McCaffrey, President & CEO of Resverlogix. “Several customary topics were discussed during our recent meeting with regards to the ongoing development requirements for apabetalone and the eventual filing of a NDA. Significantly, the Company’s overall study design for BETonMACE2 – the planned clinical study subsequent to BETonMACE – was accepted by the FDA and we expect this will greatly enhance our current and ongoing partnership discussions.”

I still dont see the additional breakthroiugh designation. The only BTD talked about is the one previously anounced.

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