An investor in HeartWare International Inc (NASDAQ:HTWR) filed a lawsuit over alleged violations of Federal Securities Laws by HeartWare International Inc.
Investors who purchased shares of HeartWare International Inc (NASDAQ:HTWR) have certain options and for certain investors are short and strict deadlines running. Deadline: March 22, 2016. NASDAQ:HTWR investors should contact the Shareholders Foundation at email@example.com or call +1(858) 779 – 1554.
The plaintiff claims that after the U.S. Food and Drug Administration (“FDA”) issued a Warning Letter identifying numerous manufacturing and other regulatory failures at the Company’s sole manufacturing facility, Defendants falsely assured investors that the Company had addressed those problems, and that they therefore posed no risk to the clinical trials or timely approval of MVAD, a pump that HeartWare International Inc is presently developing. The plaintiff says that the truth concerning the Company’s failure to remediate the regulatory failures identified by the FDA and its impact on the viability of MVAD was revealed through a series of disclosures.
On September 1, 2015, HeartWare International Inc announced the acquisition of Valtech Cardio, Ltd., a manufacturer of medical devices used to treat heart disease. The Complaint alleges that this disclosure revealed significant obstacles to the timely approval of MVAD.
On September 9, 2015, HeartWare International Inc disclosed that it had paused its MVAD clinical trial to address an MVAD controller manufacturing process issue.
On October 13, 2015, HeartWare International Inc announced that following the company’s investigation of causes of reported adverse effects in certain clinical trial patients, HeartWare might not re-initiate enrollment in the MVAD clinical trial in November as it had previously planned.
On January 11, 2016, HeartWare International Inc provided corporate updates and announced preliminary revenue expectations for the fourth quarter of 2015.
The plaintiff says that the announcement revealed that problems with MVAD had resulted in serious adverse events in nearly half of the patients so far implanted with the device, and that the trial would be delayed indefinitely.
Shares of HeartWare International Inc (NASDAQ:HTWR) declined from $90.71 per share in late July 2015 to as low as $25.02 per share on January 12, 2016.
On February 2, 2016, NASDAQ:HTWR shares closed at $39.96 per share.
Those who purchased shares of HeartWare International Inc (NASDAQ:HTWR) have certain options and should contact the Shareholders Foundation.
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