920465--3/17/2008--LA_JOLLA_PHARMACEUTICAL_CO

related topics
{product, candidate, development}
{stock, price, share}
{customer, product, revenue}
{product, liability, claim}
{product, market, service}
{property, intellectual, protect}
{interest, director, officer}
{regulation, government, change}
{personnel, key, retain}
{cost, regulation, environmental}
{control, financial, internal}
{operation, natural, condition}
{acquisition, growth, future}
{stock, price, operating}
Our independent registered public accounting firm has issued an unqualified opinion with an explanatory paragraph, to the effect that there is substantial doubt about our ability to continue as a going concern. In order to complete our current Phase 3 ASPEN study, we will need to accrue a sufficient number of renal flares by enrolling a sufficient number of patients who meet the trial criteria. If we are unable to successfully complete the trial, our business will be adversely affected and it may be difficult or impossible for us to continue to operate. Results from our clinical trials may not be sufficient to obtain regulatory approvals to market Riquent or our other drug candidates in the United States or other countries on a timely basis, if at all. We are currently devoting nearly all of our resources to the development and approval of Riquent. Accordingly, our efforts with respect to other drug candidates have significantly diminished. Current and future clinical trials may be delayed or halted. We may be required to design and conduct additional trials for Riquent. We may experience shortages of Riquent for use in our clinical studies. If we encounter delays or difficulties in establishing or maintaining relationships with manufacturing or distribution contractors, our ability to timely complete necessary clinical trials and potentially deliver commercial products may be negatively affected. Our limited manufacturing capabilities and experience could result in shortages of drugs for future sale, and our revenues and profit margin could be negatively affected. Our suppliers may not be able to provide us with sufficient quantities of materials that we need to manufacture our products. An interruption in the operation of our sole manufacturing facility could disrupt our operations. Retaining our current personnel and recruiting additional personnel will be critical to our success. We will need additional funds to support our operations. Our freedom to operate our business or profit fully from sales of our products may be limited if we enter into collaborative agreements. Any regulatory approvals that we may obtain for our product candidates may be limited and subsequent issues regarding safety or efficacy could cause us to remove products from the market. Even if we receive regulatory approval for our product candidates, we will be subject to ongoing regulatory obligations and review, including validation of our manufacturing facilities and processes. The size of the market for our potential products is uncertain. Our drugs may not achieve market acceptance. We lack experience in marketing products for commercial sale. We may not earn as much revenue as we hope due to possible changes in healthcare reimbursement policies. We have a history of losses and may not become profitable. Our success in developing and marketing our drug candidates depends significantly on our ability to obtain patent protection for Riquent and any other developed products. In addition, we will need to successfully preserve our trade secrets and operate without infringing on the rights of others. The technology underlying our products is uncertain and unproven. Because a number of companies compete with us, many of which have greater resources than we do, and because we face rapid changes in technology in our industry, we cannot be certain that our products will be accepted in the marketplace or capture market share. We may not be able to take advantage of the orphan drug designation for Riquent. The use of Riquent or other potential products in clinical trials, as well as the sale of any approved products, may expose us to lawsuits resulting from the use of these products. We face environmental liabilities related to certain hazardous materials used in our operations. II. RISK FACTORS RELATED SPECIFICALLY TO OUR STOCK. The ownership of our common stock is concentrated. Our common stock price is volatile and may decline even if our business is doing well. Future sales of our stock by our stockholders could negatively affect the market price of our stock. Our stock may be removed from listing on the Nasdaq Global Market and may not qualify for listing on any stock exchange, in which case it may be difficult to maintain a market in our stock.

Full 10-K form ▸

related documents
815508--1/29/2008--BIOPURE_CORP
1262104--9/1/2006--MARSHALL_EDWARDS_INC
855654--8/27/2010--IMMUNOGEN_INC
815508--1/29/2007--BIOPURE_CORP
1080014--2/27/2009--THERAVANCE_INC
855654--8/30/2007--IMMUNOGEN_INC
921114--3/31/2009--TARGETED_GENETICS_CORP_/WA/
1080709--3/5/2008--ARENA_PHARMACEUTICALS_INC
1140028--3/31/2008--Hana_Biosciences_Inc
880643--3/10/2006--GENTA_INC_DE/
1005201--3/6/2009--DEPOMED_INC
912183--3/1/2007--CUBIST_PHARMACEUTICALS_INC
1055726--3/26/2010--INOVIO_BIOMEDICAL_CORP
934473--3/17/2008--GENVEC_INC
1305409--2/22/2007--Valera_Pharmaceuticals_Inc
1097264--3/3/2009--ALLOS_THERAPEUTICS_INC
1068796--3/7/2008--MAXYGEN_INC
1161924--3/29/2006--ADVANCIS_PHARMACEUTICAL_CORP
1097264--2/27/2008--ALLOS_THERAPEUTICS_INC
920465--3/16/2007--LA_JOLLA_PHARMACEUTICAL_CO
1226616--3/17/2008--MEDICINOVA_INC
1123695--3/31/2008--IMARX_THERAPEUTICS_INC
1142380--3/28/2008--CALLISTO_PHARMACEUTICALS_INC
877902--3/10/2008--NEOSE_TECHNOLOGIES_INC
1142380--4/17/2007--CALLISTO_PHARMACEUTICALS_INC
1068796--3/12/2009--MAXYGEN_INC
1160308--3/17/2008--ADVENTRX_PHARMACEUTICALS_INC
1158223--3/12/2009--AFFYMAX_INC
1158223--3/4/2010--AFFYMAX_INC
877902--3/16/2007--NEOSE_TECHNOLOGIES_INC