CARISMA THERAPEUTICS, INC. Item 8.01 - Other Events
On the morning of
The FDA Warning Letter indicates that the study investigator did not comply with
applicable statutory requirements and applicable regulations regarding conduct
of clinical investigations. The study investigator operated a clinical site that
was previously part of the VISTA trial, which was closed by the Company on
When the clinical site was closed, five patients had completed treatment and were in post-treatment follow-up. There was no evidence found that patients were harmed by the study investigator's actions. The Company included the corresponding patient data from the clinical site in its BLA submission to the FDA, which were thoroughly analyzed and discussed during the BLA review.
The Company did not receive any Warning Letters or Discipline Review Letters
during the
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS:
This Current Report on Form 8-K contains forward-looking statements, including,
but not limited to, statements regarding the Company's plans to continuing to
work collaboratively with regulators to determine the appropriate path forward
for Vicineum, which are based on the Company's current expectations and
inherently involve significant risks and uncertainties. The Company's actual
results and the timing of events could differ materially from those anticipated
in such forward-looking statements as a result of these risks and uncertainties,
including the risk that the Company may not be able to determine a path forward
for Vicineum for the treatment of BCG-unresponsive NMIBC, the risk that the
Company may not resume its plans to pursue regulatory approval for Vicineum for
the treatment of BCG-unresponsive NMIBC in the US, the risk that the FDA may not
approve the BLA for Vicineum for the treatment of BCG-unresponsive NMIBC if the
Company resubmits the BLA at a future time, the risk that clinical trials of
Vicineum for the treatment of BCG-unresponsive NMIBC may fail to demonstrate
safety and efficacy to the satisfaction of the FDA, or otherwise produce
favorable results, and the risk that Vicineum for the treatment of
BCG-unresponsive NMIBC may cause undesirable side effects, serious adverse
events or have other properties that could delay or halt clinical trials, delay
or prevent its regulatory approval by the FDA, or limit the commercial profile
of its labeling, if approved, or result in significant negative consequences
following any marketing approval, among other risks and uncertainties. A further
description of the risks and uncertainties relating to the business of the
Company is contained in the Company's most recent annual report on Form 10-K and
the Company's quarterly reports on Form 10-Q, as well as any amendments thereto
reflected in subsequent filings with the
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