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SUBSEQUENT EVENTS
3 Months Ended
Mar. 31, 2020
SUBSEQUENT EVENTS  
SUBSEQUENT EVENTS

NOTE 11 SUBSEQUENT EVENTS

On January 3, 2020, we paid $2.9 million to the FDA as an NDA User Fee for umbralisib. Subsequently, on January 10, 2020, we submitted a letter to the FDA requesting a refund of the NDA User Fee under the small business waiver provision, section 736(d)(1)(C)2 of the Federal Food, Drug, and Cosmetic Act. On April 24, 2020, we received a reply from the FDA notifying us that they granted our request for the refund. The $2.9 million should be received within 45 days of the letter.

On March 11, 2020, the World Health Organization declared that the rapidly spreading strain of coronavirus, which causes a disease referred to as COVID-19, had evolved into a pandemic. In response to the pandemic, many governments around the world are implementing a variety of measures to reduce the spread of COVID-19, including travel restrictions and bans, instructions to residents to practice social distancing, quarantine advisories, shelter-in-place orders and required closures of non-essential businesses.  The pandemic and associated measures to contain it have impacted the global economy, disrupted global supply chains, affected healthcare systems, and created significant volatility in the financial markets.

COVID-19 has not had a material adverse effect on our business to date.   However, there remain many uncertainties regarding the pandemic.  As a result, the extent to which COVID-19 may impact our business in the future cannot be accurately predicted and depends on factors including the duration and severity of the pandemic and the actions taken to contain it (See Item 1A: “Risk Factors” for additional details).