No patients with Alström syndrome met the primary endpoint. Patient identification is a core focus of our cross-functional teams. We are studying Alström syndrome patients who are severely obese. This gives rise to a well-documented form of severe early-onset obesity and hyperphagia. Most often these symptoms were reported in the first week of treatment. IMCIVREE is approved in the US for patients 6 years of age and older. In this event, the NDA must be resubmitted with the additional information. The IVDR will become applicable on 26 May 2022. The purpose of the bill is to enable the existing UK regulatory frameworks to be updated. As a result, increasingly high barriers are being erected to the entry of new products. However, this consequence cannot be excluded. These changes will lead to additional costs and increase our overall risk exposure. The FDA may designate drugs for relatively small patient populations as orphan drugs. In addition, new products developed by others could emerge as competitors to IMCIVREE. Patents, if issued, may be challenged, deemed unenforceable, invalidated or circumvented. Patent litigation is costly and time consuming. We may not have sufficient resources to bring these actions to a successful conclusion. Such a loss of patent protection would have a material adverse impact on our business. We have licensed our rights to setmelanotide from Ipsen Pharma SAS, or Ipsen. The off-label promotion of medicinal products is prohibited in the EU. We may be subject to federal and state healthcare and privacy laws and regulations. Our quarterly operating results may fluctuate significantly. As of December 31, 2020, we had 44,235,903 shares of common stock outstanding.
