b'District of Massachusetts Cases to Watch in 2021Afinowicz v. LogicBio Therapeutics, Inc., etstatements concerning the LB 001 developmental., Case No. 1:20-cv-11158 (WGY) (D. Mass.)timeline that misleadingly failed to disclose:(1) that LogicBios IND application for LB-001 was Timeline of FDA Submissions behind-schedule and rushed and did not answer LogicBio Therapeutics, Inc. (LogicBio) is a Cambridge,pertinent clinical and nonclinical questions, and that Massachusetts-based genome editing company fo- (2) as a result, FDA was likely to delay or deny the IND cused on developing medicines to treat rare diseasesapplication. On June 18, 2020, the case was transferred using its GeneRide technology platform. LogicBiosto the District of Massachusetts. The court has not yet primary product candidate is LB-001 for the treat-appointed a lead plaintiff. Once appointment is made, ment of Methylmalonic Acidemia (MMA), a life-an amended complaint is expected to be filed withinthreatening genetic condition manifesting at birth.45 days. Between December 2018 and January 2020, Logic- Bio and certain of its officers made a series of state- Jevons v. Boston Scientific Corporation, ments regarding the companys timeline for filing anCase No. 1:21-cv-10033 (NMG) (D. Mass.) Investigational New Drug Application (IND) for LB-001. For example, LogicBio disclosed in its April 2019 FormMedical Device Global Recall10-K and in press releases throughout 2019 that theBoston Scientific Corporation (Boston Scientific) is a application was expected to be submitted this year.Massachusetts-based company that develops, man-LogicBio also made a series of statements in 2019ufactures, and markets medical devices. One of its regarding its intent to initiate a Phase 1/2 trial of LB-001products is the LOTUS Edge Aortic Valve System (the in pediatric MMA patients in the first half of 2020.LOTUS Edge), a transcatheter aortic valve replace-On January 10, 2020, LogicBio issued a press releasement system for patients with severe aortic stenosis announcing submission of an IND for LB-001 to FDA.who are at a high risk for surgical valve replacement via In the following days, LogicBio several times publiclyopen heart surgery.reaffirmed its timeline for LB-001, including noting that the Phase 1/2 trial would be initiated in the first half ofOn April 23, 2019, Boston Scientific announced FDAs 2020, with preliminary data expected in the second halfapproval of the LOTUS Edge and described the LOTUS of 2020. However, in February 2020, LogicBio issued aEdges strengths. In its quarterly financial press releas-press release disclosing that FDA had placed a clinicales over the next year, Boston Scientific disclosed that hold on its IND application pending the resolution ofLotus Edge had demonstrated significant, sustained certain clinical and nonclinical questions, includingimprovement in patient outcomes, with minimal ad-questions related to LogicBios studies of LB-001. Theverse effects, and that the product had been approved press release disclosed that LogicBio expected FDA toin Japan. In its 2019 10-K, Boston Scientific reported provide written questions within 30 days, and that thethat its Interventional Cardiology subsegment, includ-company would work with FDA to resolve the questionsing the Lotus Edge, had over $2.8 billion in net sales as quickly as possible. LogicBios share price droppedduring 2019, representing 26% of the companys overall approximately 32% on the announcement.net sales. However, on November 17, 2020, Boston Investors filed a putative class action complaint origi- Scientific issued a press release announcing a global nally in the District of New Jersey on March 18, 2020,recall of all unused inventory of the LOTUS Edge due to asserting claims under Sections 10(b) and 20(a) of thecomplexities associated with the product delivery sys-1934 Act and Rule 10b-5 promulgated thereunder.tem. The press release also announced that, because The complaint alleges that defendants issued publicdeveloping and reintroducing an enhanced delivery 20'