Northern,WI  2/11/2013 (BasicsMedia) – As the East Coasts Dig out, these companies are also looking to turn things around and dig out of the hole morning trading has seen them fall into.

Taking a 13% dip in morning trading we find Novo Nordisk (NVO). The fall from grace started today after the Danish drugmaker said U.S. regulators wanted more data before they can finish their review of two long-acting insulin drugs to treat diabetes. The company said Sunday that the Food and Drug Administrationrequested information from a study that looks at cardiovascular health before it can finish reviewing Tresiba and Ryzodeg.

Novo Nordisk said it was surprised and disappointed by the decision. The company plans to provide the requested data, but it probably will not be able to do that this year. The F.D.A. also told the drugmaker it could not approve the drugs until the company resolved some manufacturing violations the agency outlined in a recent warning letter. The Dec. 12 letter said an inspection of the company’s drug-making factory in Denmark found significant violations of good manufacturing practices.

The letter accused the company of not establishing or following appropriate written procedures for preventing contamination of sterile drug products.

The Heckmann Corporation (HEK) is down over 7% in trading so far today while trading well above their daily average.

The Heckmann Corporation operates as a services-based company focused on total water and wastewater solutions for shale or unconventional oil and gas exploration and production. The company offers water delivery and disposal, trucking, fluids handling, treatment, temporary and permanent pipeline facilities, and water infrastructure services for oil and gas exploration and production companies. It operates multi-modal water disposal, treatment, trucking, and pipeline transportation operations in select shale areas in the United States, including the Eagle Ford, Haynesville, Marcellus, Utica, Barnett, and Tuscaloosa Marine Shale areas. The company also transports fresh water for production; and provides services for site preparation, water pit excavations, and remediation. It serves customers seeking fresh water acquisition, temporary water transmission and storage, transportation, treatment or disposal of fresh water, and complex water flows, such as flowback and produced brine water in connection with shale oil and gas hydraulic fracturing drilling operations.

Our last downward mover of the morning is ImmunoCellular Therapeutics, Ltd. (IMUC)  which is off just over 6% today. The company recently announced that the US Food and Drug Administration (FDA) has allowed the investigational new drug (IND) application for ICT-140, paving the way for conducting a clinical trial. ICT-140 is a dendritic cell vaccine targeting seven antigens that are over-expressed in ovarian cancer, as well as cancer stem cells. ImmunoCellular filed the IND application with the FDA in the fourth quarter of 2012, as planned.

The clinical trial of ICT-140 will be a Phase IIa open-label safety study, and is anticipated to enroll approximately 20 patients with ovarian cancer who have been previously treated with standard chemotherapeutic agents, in 3-4 clinical sites in the US. ImmunoCellular anticipates initiating the trial in the second half of 2013.

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