San Diego, CA -- (SBWIRE) -- 10/29/2020 -- An investor, who purchased OTC: MEOBF shares, filed a lawsuit against Mesoblast Limited over alleged violations of Federal Securities Laws.

Investors who purchased shares of Mesoblast Limited (OTC: MEOBF) have certain options and for certain investors are short and strict deadlines running. Deadline: December 7, 2020. OTC: MEOBF investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

In early 2020, Mesoblast Limited completed its rolling submission of its Biologics License Application ("BLA") with the U.S. Food and Drug Administration ("FDA") to secure marketing authorization to commercialize remestemcel-L for children with steroid refractory aGVHD.

On August 11, 2020, the FDA released briefing materials for the August 13, 2020 meeting of the FDA's Oncologic Drugs Advisory Committee, at which the FDA will review and discuss Mesoblast's marketing application for Ryoncil (remestemcel-L) for the treatment of steroid-refractory acute graft-versus-host disease in pediatric patients. The FDA briefing documents stated that it is "unclear" whether the study results supporting Mesoblast's application are "relevant" to the proposed indication for use.

On October 1, 2020, Mesoblast Limited disclosed that it had received a Complete Response Letter ("CRL") from the FDA regarding its marketing application for remestemcel-L for treatment of SR-aGVHD in pediatric patients. According to the CRL, the FDA recommended that the Company "conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD." The CRL also "identified a need for further scientific rationale to demonstrate the relationship of potency measurements to the product's biologic activity."

The plaintiff claims that between April 16, 2019 and October 1, 2020, the Defendants failed to disclose to investors, that comparative analyses between Mesoblast's Phase 3 trial and three historical studies did not support the effectiveness of remestemcel-L for steroid refractory aGVHD due to design differences between the four studies, that, as a result, the FDA was reasonably likely to require further clinical studies, that, as a result, the commercialization of remestemcel-L in the U.S. was likely to be delayed, and that, as a result of the foregoing, Defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

Those who purchased shares of Mesoblast Limited (OTC: MEOBF) have certain options and should contact the Shareholders Foundation.

Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North - Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com

About Shareholders Foundation, Inc.
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