Neurocrine Biosciences ( NBIX) will meet next month with federal regulators on securing approval of its insomnia drug Indiplon as the company faces a massive cash burn and a possible decision on its sales force headcount. Neurocrine provided an update Monday as it tries to overcome regulatory setbacks that have caused its stock to fall and result in Pfizer ( PFE) canceling a marketing partnership for a drug that had appeared to be headed for the market this year. In mid-May, San Diego-based Neurocrine said the FDA delayed approval of an immediate-release version of Indiplon. The FDA also rejected an application for an extended-release version, which analysts have said offers greater sales potential. A month later, Neurocrine reported that discussions with the FDA indicated that the company might need to provide more clinical and/or preclinical safety data for the immediate-release version and would "likely" need to conduct more clinical trials for the long-acting version. "We continue to pursue activities to expedite successful registration and commercialization of Indiplon and look forward to meeting with the FDA to finalize development plans for the resubmission of each Indiplon application ," said Gary A. Lyons, the company's president and CEO. Lyons said he will need more information from the FDA before he considers talking to potential partners. In recent weeks, Neurocrine has been preparing to meet with the FDA "to seek clarity and direction from the agency necessary for resubmission" of applications for both versions of Indiplon, the company said. The meeting for the immediate-release capsules will be held in August. The company issued its Indiplon update as it announced second-quarter financial results. For the three months ended June 30, it lost $27.4 million, or 73 cents a share, compared with a net loss of $5.6 million, or 15 cents a share, for the same period last year. Second-quarter revenue was $9.2 million vs. $33.2 million for the same period last year.