2 unchanged sentences
In March 2020, the World Health Organization declared COVID-19 a global pandemic and the United States declared a national emergency with respect to COVID-19.
−Removed: The COVID-19 pandemic continues affect the U.S.
+Added: The COVID-19 pandemic continues to affect the U.S.
and global economies and may affect our operations and certain other third parties on which we rely, including by causing disruptions in the supply of our product candidates and the conduct of future clinical trials.
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• interruption of key clinical trial activities, such as clinical trial site data monitoring and efficacy, safety and translational data collection, processing and analyses, due to limitations on travel imposed or recommended by federal, state or local governments, employers and others or interruption of clinical trial subject visits, which may impact the collection and integrity of subject data and clinical study endpoints;
−Removed: • delays or disruptions in preclinical experiments and IND-enabling studies due to restrictions of on-site staff and unforeseen circumstances at CROs and vendors, including any delays caused by the COVID-19 outbreak;
+Added: • delays or disruptions in preclinical experiments and IND-enabling studies due to restrictions of on-site staff and unforeseen circumstances at CROs and vendors, including any delays caused by the COVID-19 pandemic;
• interruption or delays in the operations of the FDA and comparable foreign regulatory agencies;
1 unchanged sentence
• delays in receiving approval from local regulatory authorities to initiate our planned clinical trials;
−Removed: • limitations on employee or other resources that would otherwise be focused on the conduct of our clinical trials and pre-clinical work, including because of sickness of employees or their families, the desire of employees to avoid travel or contact with large groups of people, an increased reliance on working from home, school closures or mass transit disruptions;
+Added: • limitations on employee or other resources that would otherwise be focused on the conduct of our clinical trials and pre-clinical work, including because of sickness of employees or their families, the desire of employees to avoid travel or contact
+Added: with large groups of people, an increased reliance on working from home, school closures or mass transit disruptions or the refusal of employees to comply with COVID-19 vaccine mandates;
• changes in regulations as part of a response to the COVID-19 pandemic which may require us to change the ways in which our clinical trials are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether;
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The COVID-19 global pandemic remains a public health threat and its ultimate impact on our business and the global economy is uncertain.
−Removed: The extent to which the outbreak may affect our clinical trials, business, financial condition and results of operations will depend on future developments, which are highly uncertain and cannot be predicted at this time, such as the ultimate geographic spread of the disease, the duration of the outbreak, travel restrictions, actions to contain the outbreak or treat its impact, such as social distancing and quarantines or lock-downs in the United States, and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease, and the ongoing worldwide vaccine rollout.
+Added: The extent to which the pandemic may affect our clinical trials, business, financial condition and results of operations will depend on future developments, which are highly uncertain and cannot be predicted at this time, such as the ultimate geographic spread of the disease, the duration of the pandemic, travel restrictions, actions to contain the pandemic or treat its impact, such as social distancing and quarantines or lock-downs in the United States, and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease, and the ongoing worldwide vaccine rollout and implementation of vaccine mandates.
Future developments in these and other areas present material uncertainty and risk with respect to our clinical trials, business, financial condition and results of operations.
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3.2 Amended and Restated Bylaws of Vallon Pharmaceuticals, Inc.
−Removed: (incorporated by reference to Exhibit 3.3 to the Current Report on form 8-K, filed with the SEC on February 16, 2021).
+Added: (incorporated by reference to Exhibit 3.3 to the Current Report on F orm 8-K, filed with the SEC on February 16, 2021).
3.3 Certificate of Amendment to Amended and Restated Certificate of Incorporation of Vallon Pharmaceuticals, Inc.
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101.PRE iXBRL Taxonomy Extension Presentation Linkbase Document
−Removed: 104 Cover Page Interactive Date File (formatted as Inline XBRL and contained in Exhibit 101)
+Added: 104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
____________________________________
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VALLON PHARMACEUTICALS, INC.
−Removed: August 10, 2021 By:
+Added: November 12, 2021 By:
/s/ Leanne M.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.