Interim data from this expansion cohort is anticipated by the end of 2021. & & 8226; Conventional Manufacturing. We will be responsible for developing HPN217 through a Phase 1/2 clinical trial. 3) Expedite commercial presence and distribution of our products, if approved. Interim data from this expansion cohort is anticipated by the end of 2021.& & In 2018, we completed an IND-enabling, multi-dose GLP toxicology study in animals. One CRS grade 3 occurred in the absence of dexamethasone premedication treatment. Effective treatment options for patients with mesothelioma are very limited. Royalties on net sales will be recognized when the underlying sales occur. For more information, see "Item 3. Below is a summary of how we view our protections and ongoing prosecution efforts.& & An IND must become effective before human clinical trials may begin. These so-called Phase 4 studies may be made a condition to approval of the BLA. The BPCIA is complex and continues to be interpreted and implemented by the FDA. As of February 28, 2021, we had 78 full-time employees. Further, new studies may change the estimated incidence or prevalence of these cancers. We may not be able to build an effective sales and marketing organization. In addition, there is a natural transition period when a new CRO commences work. We may not be able to negotiate collaborations on acceptable terms, or at all. We rely on third-party manufacturers to produce our product candidates. We may license our trademarks and trade names to third parties, such as distributors. Such an outcome could have a material adverse effect on our business. This applies to all of our U.S. patents, even those issued before March 16, 2013. Cyber threats may be generic, or they may be targeted against our information systems. Item 1B. Unresolved Staff Comments Not applicable.