Item 7.01. Regulation FD Disclosure.
On
While Company officers and other members of management have responded to many inquiries from analysts and investors since the announcement, to further address this confusion and provide clarity, the Company wishes to reiterate the following:
· The Company has paused enrollment of new patients in clinical trials with
BCX9930; however, patients currently enrolled in the trials continue to receive BCX9930 at this time. Patients currently enrolled are primarily PNH patients.
· Until the Company completes its recently initiated investigation and consults
its medical experts and appropriate regulatory authorities, the Company cannot predict the likelihood of any potential outcomes, including, but not limited to, the potential resumption of trial enrollments, or a potential decision not to continue the trials. The Company is working to complete the investigation as quickly as possible.
· As the Company has explained in response to investor inquiries, because the
situation is fluid and information can change quickly, the Company is focused on completing the investigation in order to have the full picture of the situation before providing additional details surrounding the pause in trial enrollments.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements, including
statements regarding BioCryst's plans for its BCX9930 program. These statements
involve known and unknown risks, uncertainties and other factors which may cause
actual results, performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by the
forward-looking statements. These statements reflect our current views with
respect to future events and are based on assumptions and are subject to risks
and uncertainties. Given these uncertainties, you should not place undue
reliance on these forward-looking statements. Some of the factors that could
affect the forward-looking statements contained herein include: the timing and
results of the investigation described in this Current Report on Form 8-K
regarding BCX9930; ongoing and future preclinical and clinical development of
BCX9930 may not have positive results; BioCryst may not be able to enroll the
required number of subjects in planned clinical trials of product candidates;
BioCryst may not advance human clinical trials with product candidates as
expected; and the FDA or other applicable regulatory agency may require
additional studies beyond the studies planned for product candidates, may not
provide regulatory clearances which may result in delay of planned clinical
trials, may impose certain restrictions, warnings, or other requirements on
product candidates, or may impose a clinical hold with respect to product
candidates. Please refer to the all documents BioCryst files periodically with
the
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