10 unchanged sentences
that has been placed on our IND by the FDA, it may take considerable time and expense to respond to the FDA and no assurance can
−Removed: be given that the FDA will remove the clinical hold in which case our business and prospects may suffer material adverse consequences.
+Added: be given that the FDA will remove the clinical hold in which case our business and prospects will likely suffer material adverse
+Added: consequences.
On October 1, 2020, we received notice
3 unchanged sentences
It may take a considerable
−Removed: period of time, the length of which is unknown at this time, for us to conduct such tasks and preclinical studies and to prepare
−Removed: such requested information.
−Removed: In addition, the significant expense of such work is likely to require us to raise additional capital.
−Removed: It is possible that the service providers that we will utilize for such work may have considerable backlogs and/or are suffering
−Removed: from slowdowns as a result of COVID-19 and may not be able to perform such work for an extended period of time.
−Removed: Even if we are
−Removed: able to fully respond to the FDA’s request, they may subsequently make additional requests that we would need to fulfill
−Removed: prior to the lifting of the clinical hold and we may never be able to begin clinical trials, obtain regulatory approval or obtain
−Removed: commercialization for our product candidates.
−Removed: An inability to conduct clinical trials as a result of the clinical hold or otherwise,
−Removed: would likely force us to terminate our clinical development plans.
−Removed: It is possible that we will be unable to fully respond to the
−Removed: FDA in a satisfactory manner, and as a result the clinical hold may never be lifted.
−Removed: If the clinical hold is not lifted or if the
−Removed: lifting takes an extended period of time, our business and prospects may suffer material adverse consequences.
+Added: period of time, the length of which is unknown at this time, for us to conduct such tasks and preclinical studies and to generate
+Added: and prepare the requested information.
+Added: In addition, the significant expense of such work is likely to require us to raise additional
+Added: It is possible that the service providers that we will utilize for such work may have considerable backlogs and/or are
+Added: suffering from slowdowns as a result of COVID-19 and may not be able to perform such work for an extended period of time.
+Added: if we are able to fully respond to the FDA’s requests, they may subsequently make additional requests that we would need
+Added: to fulfill prior to the lifting of the clinical hold and we may never be able to begin our clinical trial in LAPC, obtain regulatory
+Added: approval or obtain commercialization for our product candidates.
+Added: An inability to conduct clinical trial in LAPC as a result of
+Added: the clinical hold or otherwise, would likely force us to terminate our clinical development plans.
+Added: It is possible that we will
+Added: be unable to fully respond to the FDA in a satisfactory manner, and as a result the clinical hold may never be lifted.
+Added: If the clinical
+Added: hold is not lifted or if the lifting takes an extended period of time, our business and prospects will likely suffer material adverse
+Added: consequences.
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.