ARCA Biopharma Inc (ABIO)

[RNsidersbuying]

The Proposed Gencaro Phase 3 Clinical Trial

The PRECISION-AF Phase 3 clinical trial is designed as a double-blind, active-controlled, multicenter, international, adaptive study comparing Gencaro with TOPROL-XL for the prevention of recurrent AF/atrial flutter, or AF/AFL, or all-cause mortality, or ACM, in HF patients. The study will enroll approximately 400 patients at investigative sites in the United States, Europe and Australia. Eligible patients will have LVEF ≥ 0.40 and ≤ 0.55, a recent AF event, and the beta-1 389 arginine homozygous genotype which we believe responds most favorably to Gencaro. The planned trial will use standard significance criteria (p < 0.01 with adjustment for interim analysis) for the primary endpoint and will include an interim analysis after a portion of total patients have been enrolled. The interim analysis is designed to assess safety, validate initial study assumptions and maintain adequate statistical power for the primary endpoint. Subject to securing additional financing, we anticipate initiating PRECISION-AF in the first quarter of 2020. Any future development of Gencaro, including initiating any Phase 3 clinical trial, is dependent on obtaining significant additional financing, even if we enter into a strategic collaboration around the development of Gencaro.

https://secfilings.nasdaq.com/filingFrameset.asp?FilingID=13723541&RcvdDate=11/6/2019&CoName=ARCA%20BIOPHARMA%2C%20INC.&FormType=10-Q&View=html

Sure sounds like the insiders are telling the outsiders to wait???