As a result of the
COVID-19
pandemic, various aspects of our business operations have been, and could continue to be, disrupted. In response to the pandemic, we implemented a work from home policy, with our administrative and certain other employees continuing their work outside of our offices, and restricted
on-site
staff to only a limited number of employees who have critical needs to be in the facility. The increase in working remotely could increase our cyber security risk, create data accessibility concerns, and make us more susceptible to communication disruptions, any of which could adversely impact our business operations or delay necessary interactions with local and federal regulators, ethics committees, manufacturing sites and clinical trial sites. In addition, as a result of
orders or other mandated travel restrictions, staff conducting
on-site
research and development may have limited access to our laboratory space, and these core activities may be significantly limited or curtailed, possibly for an extended period of time.
The
COVID-19
pandemic has also reduced the ability to engage with the medical and investor communities, including due to the cancellation or reformatting of conferences scheduled throughout the year. For example, in light of the
COVID-19
pandemic, we temporarily suspended our field team from most
in-person
interactions, including visits to physician offices, clinics and hospitals as well as
in-person
meetings with payors. These and other measures may significantly impact our ability to commercialize Oxbryta, such as by impacting new patient enrollments.
In addition, our ongoing and planned clinical trials have been and will likely continue to be affected by the
COVID-19
pandemic. For example, in light of the
COVID-19
pandemic, we temporarily paused screening and enrollment in all
GBT-sponsored
clinical studies (other than, where feasible, certain contracting and other administrative study
start-up
activities). Activities on our clinical trials have now resumed, with measures in place that we believe are appropriate. Assessment of the long-term impact of
COVID-19
on our clinical trials is ongoing, and it is unknown whether we will be required to pause or delay such activities again in the future. Any prolongation or
de-prioritization
of our clinical trials or delay in regulatory review resulting from such disruptions could materially affect the development and study of Oxbryta or our product candidates. Study procedures (particularly any procedures that may be deemed
non-essential),
site initiation, participant recruitment and enrollment, participant dosing, shipment of our study compound, distribution of clinical trial materials, study monitoring, site inspections and data analysis may be delayed or paused due to changes in hospital or research institution policies, federal, state or local regulations, prioritization of hospital and other medical resources toward pandemic efforts, or other reasons related to the pandemic. If
COVID-19
continues to spread, some participants and clinical investigators may not be able to comply with clinical trial protocols and we may experience increased patient study withdrawals or protocol deviations. For example, this may occur if quarantines or other travel limitations (whether voluntary or required) may impede participant movement, affect access to study sites, or interrupt healthcare services for a prolonged period of time. As a result, we may be unable to conduct our clinical trials.
Furthermore, the
COVID-19
pandemic has resulted in, and could continue to cause, interruptions or delays in the operations of the FDA and other domestic or foreign regulatory agencies, which could impact the conduct of our clinical trials, the ability to seek agency input on our regulatory strategies and potential filings or interactions with regulatory agencies that oversee our research, development and promotional activities. For example, the
COVID-19
pandemic has led the FDA to place some foreign and domestic inspections on hold. Should the FDA determine that an inspection is necessary for approval of a marketing application and an inspection cannot be completed during the review cycle due to restrictions on travel, FDA has stated that it generally intends to issue a complete response letter. Additionally, if there is inadequate information to make a determination on the acceptability of a facility, FDA may defer action on the application until an inspection can be completed. Regulatory authorities outside the United States may adopt similar restrictions or other policy measures in response to the
COVID-19
pandemic and may also experience delays in their regulatory activities. The extent and impact of such any such disruptions or delays are currently unpredictable.
Our and our vendors’ and collaborators’ research, preclinical development, and manufacturing operations also may be adversely impacted by the
COVID-19
pandemic. We currently utilize third parties to, among other