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Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the timing of our submission of applications for regulatory approvals, EMA, FDA and other regulatory approvals for our product candidates, the occurrence of side effects or serious adverse events caused by or associated with our products and product candidates; our ability to procure adequate quantities of necessary supplies and raw materials for USAN: lutetium Lu 177 dotatate/INN: lutetium () and other chemical compounds acceptable for use in our manufacturing processes from our suppliers; our ability to organize timely and safe delivery of our products or product candidates by third parties; any problems with the manufacture, quality or performance of our products or product candidates; the rate and degree of market acceptance and the clinical utility of USAN: lutetium Lu 177 dotatate/INN: lutetium (), our other product candidates and our existing products; our anticipation that we will generate higher sales as we diversify our products; our ability to implement our growth strategy including expansion in the US; our ability to sustain and create additional sales, marketing and distribution capabilities; our intellectual property and licensing position; legislation or regulation in countries where we sell our products that affect product pricing, taxation, reimbursement, access or distribution channels; regulatory actions or litigation; and general economic, political, demographic and business conditions in Europe, the US and elsewhere.

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No additional clinical studies were requested in the CRL and there were no comments at that time on other sections of the NDA submission.to my website – and my relationship books – where you will find refreshingly different advice that bypasses the need for better communication!My spiritually-based relationships advice is different because it explains Most couples think, "We'd be happy if we could just solve our relationship problem," and they have the illusion that by discussing the problem, they will solve it. What is true instead, is that if you focus on feeling happy together (by using my 8 spiritually-based Loving Actions), you will develop a broader consciousness, and your problem will disappear.It is a similar distance to the bamboo-baked fish and chicken dishes served at Lepau Restaurant.A 15-minute walk takes the visitor to Tun Jugah Shopping Center and to the Sarawak Museum which is the oldest museum in Borneo.




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