We refer to our collaboration with Neurocrine as the Neurocrine Collaboration. All such activities were completed on or prior to September 30, 2020. We have a deep pipeline of AAV gene therapy programs in various stages of development. 9679;Retain commercialization rights to our programs. We believe the existing process is scalable to substantially higher volumes. Parkinson's disease is characterized by a loss of dopamine and its function. We have completed enrollment and the three-year follow-up for PD-1101. The designation was based on our Phase 1b clinical data with VY-AADC (NBIb-1817)). No signs of toxicity were reported. The project commenced in January 2015 and completed during 2016. We presently contract with third parties for the manufacturing of our program materials. In some cases, these rights may need to be enforced by third-party licensors. Patents have been granted in the United States, Europe and Japan. The FDA may grant deferrals for submission of data or full or partial waivers. After a BLA is approved, the product also may be subject to official lot release. Thereafter, the U.S. Supreme Court agreed to hear this case. On February 10, 2021, the Biden Administration withdrew DOJ's support for this lawsuit. We cannot predict, however, how changes in these laws may affect our future operations. Only two AAV gene therapy products have been approved in the United States. There are risks associated with direct delivery of AAV gene therapy into the brain. Limited clinical data are available for this route of administration. We may seek such a designation for our 71 Table of Contentsother product candidates. In connection with the amendment, we received a $5.0 million payment from Neurocrine. Given the nature of biologics manufacturing, there is a risk of contamination. The insurance coverage and reimbursement status of newly-approved products is uncertain. A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Some countries require approval of the sale price of a drug before it can be marketed. Similar challenges exist in other jurisdictions. Litigation may be necessary to defend against these claims. We may not be able to obtain such exclusivity for our products. The price of our common stock is likely to be volatile and may fluctuate substantially.
