37 • the approval policies or regulations of the FDA, EMA or comparable foreign regulatory r authorities may significantly change in a manner rendering our clinical data insuffic f ient for approval. This lengthy approval process, as well as the unpredictabi a lity of the results of clinical trials, may result in our failing to obtain regulatory r approval to market any of our product candidates, which would significantly harm our business, results of operations, and prospects. We have conducted clin l ical trials for our product candid d at d es t outside d the United t Stat t es t (or the respectiv t e jurisd i ic d tions of othe t r regu e latory authorities), and the FDA D (or EMA M and applic l ablel foreign g regu e latory authoritie t s) may a not accept e datat from such trials. We have conducted one or more of our clinical trials outside the United States, including Europe and other foreign countries. The acceptance of study t data from global clinical trials by the FDA, EMA or applicable foreign regulatory r authority may be subj u ect to certain conditions. In cases where data from foreign clinical trials are intended to serve as the basis for marketing approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless (1) the data are applicable to the U.S. population and U.S. medical practice and (2) the trials were performed by clinical investigators of recognized competence and pursuant to GCP regulations. Additionally, the FDA’s clinical trial requirements, including sufficient size of patient populations and statistical powering, must be met. Many foreign regulatory r bodies have similar approval requirements. In addition, such foreign trials would be subj u ect to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA, EMA or any applicable foreign regulatory r authority will accept data from trials conducted outside of their respective jurisdiction. If the FDA, EMA or any applicable foreign regulatory r authority does not accept such data, it would result in the need for additional trials, which would be costly and time-consuming, would delay aspects of our business plan and which may result in our product candidates not receiving approval or clearance for commercialization in the applicable jurisdiction. Obtaining and maintaining regu e latory approval of our product candid d at d es t in one jurisd i ic d tion does not mean that we will i be successful f in obtai t ni i ng i regu e latory approval of our product candid d at d es t in othe t r jurisd i ic d tions. Obtaining and maintaining regulatory r approval of our product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any other jurisdiction, but a failure or delay in obtaining regulatory r approval in one jurisdiction may have a negative effe f ct on the regulatory r approval process in others. For example, even if the FDA, EMA or grants marketing approval of a product candidate, we would not be permitted to manufact f ur t e, market or promote the product candidate in other countries unless and until comparable regulatory r authorities in foreign jurisdictions had approved the candidate for use in their countries. Approval procedur d es vary among jurisdictions and can involve requirements and administrative review periods different from those in the United States, including additional preclinical studi t es or clinical trials. There can be no assurance that any clinical trials conducted in one jurisdiction will be accepted by regulatory r authorities in other jurisdictions. Obtaining foreign regulatory approvals and compliance with foreign regulatory r requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our products in certain countries. If we or any collaborator we work with fail to comply with the regulatory r requirements in international markets or fail to receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of our product candidates will be harmed. Even if we obtai t n i regu e latory approval for a product candid d at d e, t our productst will i remain subject to extensive regu e latory scrutiny. n If any of our product candidates are approved, they will be subj u ect to on-going regulatory r requirements for manufac f turing, labe a ling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studi t es and subm u ission of safety, effi f cacy and other post-market information, including both federal and state requirements in the United States and requirements of comparable foreign regulatory r authorities. Manufact f ur t ers and manufact f ur t ers’ facilities are required to comply with extensive requirements imposed by the FDA, EMA and comparable foreign regulatory r authorities, including ensuring that quality control and manufact f ur t ing procedur d es confor f m to cGMP regulations. As such, we and our contract manufact f ur t ers will be subj u ect to continual review and inspections to assess compliance with cGMP and adherence to commitments made in any BLA or marketing authorization application, or MAA. Accordingly, we and others with whom we work must continue to expend time, money and effo f rt in all areas of regulatory r compliance, including manufactur t ing, production and quality control.