https://s28.q4cdn.com/781576035/files/doc_financials/2021/q4/Q4-2021-Earnings-Conference-Call-Prepared-Remarks-FINAL.pdf
In der Bleiwüste ab Seite 21 verortet.
Risks Related to Our Business, Industry and Operations, and Business Development:
• the outcome of research and development (R&D) activities, including, the ability to meet anticipated
pre-clinical or clinical endpoints, commencement and/or completion dates for our pre-clinical or
clinical trials, regulatory submission dates, and/or regulatory approval and/or launch dates; the
possibility of unfavorable pre-clinical and clinical trial results, including the possibility of unfavorable
new pre-clinical or clinical data and further analyses of existing pre-clinical or clinical data; the risk
that pre-clinical and clinical trial data are subject to differing interpretations and assessments,
including during the peer review/publication process, in the scientific community generally, and by
regulatory authorities; and whether and when additional data from our pipeline programs will be
published in scientific journal publications and, if so, when and with what modifications and
interpretations;
• our ability to successfully address comments received from regulatory authorities such as the U.S.
Food and Drug Administration or the European Medicines Agency, or obtain approval for new
products or indications from regulators on a timely basis or at all; regulatory decisions impacting
labeling, including the scope of indicated patient populations, product dosage, manufacturing
processes, safety and/or other matters, including decisions relating to emerging developments
regarding potential product impurities;
Man muss ja nach dem Richterspruch mehr als 50 Seiten pro Monat der Zulassungsunterlagen veröffentlichen...