33 • the lack of complementary r products to be offe f red by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and • unfor f eseen costs and expenses associated with creating an independent commercialization organization. If we enter into arrangements with third parties to perform sales, marketing, commercial suppor u t and distribution services, our product revenue or the profit f ability of product revenue may be lower than if we were to market and sell any products we may develop ourselves. In addition, we may not be successful f in entering into arrangements with third parties to commercialize our product candidates or may be unabl a e to do so on terms that are favorable to us. We may have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our products effe f ctively. If we do not establ a ish commercialization capabilities successful f ly, either on our own or in collaboration with third parties, we will not be successful f in commercializing our product candidates if approved. Even if any n product candid d at d es t we develop l receive marketin t g approval,l they may a fail to achieve the degr e ee of market acceptance by phys h icians,s patie t nts, t health l care payorsr and othe t rs in the medical community i necessary for commercial success. The commercial success of any of our product candidates will depend upon its degree of market acceptance by physicians, patients, third-party payors and others in the medical community. Even if any product candidates we may develop receive marketing approval, they may nonetheless fail to gain suffic f ient market acceptance by physicians, patients, healthcare payors, and others in the medical community. The degree of market acceptance of any product candidates we may develop, if approved for commercial sale, will depend on a number of factors, including: • the effi f cacy and safety of such product candidates as demonstrated in pivotal clinical trials and published in peer- reviewed journals; • the potential and perceived advantages of our product labe a l as compared to alternative treatments; • the ability to offe f r our products for sale at competitive prices; • the ability to offe f r appropriate patient access programs, such as co-pay assistance; • the extent to which physicians recommend our products to their patients; • convenience and ease of dosing and administration compared to alternative treatments; • the clinical indications for which the product candidate is approved by FDA, EMA or other regulatory r agencies; • product labe a ling or product insert requirements of the FDA, EMA or other comparable foreign regulatory r authorities, including any limitations, contraindications or warnings contained in a product’s approved labe a ling; • restrictions on how the product is distributed; • the timing of market introduc d tion of competitive products; • publicity concerning our products or competing products and treatments; • the strength of marketing and distribution suppor u t; • sufficient third-party coverage or reimbursement; and • the prevalence and severity of any side effe f cts. If any product candidates we develop do not achieve an adequate level of acceptance, we may not generate signific f ant product revenue, and we may not become profita f bl a e.