I have read this class file action. I can't remember at any time the discussions about the (old) trails or why this would need to be disclosed to shareholders. Can any one remember an Ann. that gave us the details of their meeting with ODAC before the meeting? No! Perhaps I am reading this wrong.
The complaint, filed on October 8, 2020, alleges that throughout the Class Period defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, defendants failed to disclose to investors: (1) 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; (2) that, as a result, the FDA was reasonably likely to require further clinical studies; (3) that, as a result, the commercialization of remestemcel-L in the U.S. was likely to be delayed; and (4) 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.
However, I do believe that it was a full discloser on MSB part to discuss such results (to ODAC) if only to demonstrate the improvements to the new and improved product. If this is to be used against them, I feel that this will be proven to be ethical and responsible on MSB part. FDA have pushed back with need of more trial info. So be it. They(MSB) have the results and that speaks volumes.
Lawyers being lawyers and sad investors that need to pass blame for thinking anything on disallowed is a sure thing. Notice this is for only US exchange. Ugh! So stupid like the 'fly on Pence head' Air time
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