$heff's $tation of $tocks & $olid DD

[$$$eeker]

$CERS $7.51

Catalysts

The company is now attempting to receive approval for the product in the United States. Cerus has already completed Phase III trials for the Intercept System for the platelet and plasma indications. On December 4, 2013, the company submitted a Pre-market Approval (PMA) application to the FDA for the plasma indication. Using the FDA's 90-day guideline for review, Cerus should expect to hear about approval by the end of February or very early March for that indication. The company also stated that it is planning to submit the last module of the PMA for platelets by March 2014. Using the same timeline, that would put potential partial approval of the product by May 2014.

Since the company has extensive data from the European Union, the FDA has allowed the company to submit without undergoing more trials. Approval for this product in the United States would increase sales and better position the company to further its trials for the use on red blood cells. Cerus expects both products to be approved and marketed by the second half of 2014. The company seems confident in receiving approval because they just announced additions to a North American sales team. If all things go as planned, 2014 could be an inflection point for the company.

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