TScan Therapeutics Inc (TCRX)

[FACT-MASTER]

"We plan to seek a Breakthrough Therapy designation for our current
or future product candidates and may seek Breakthrough Therapy
designation for some or all of our future product candidates. A
breakthrough therapy is defined as a drug or biologic that is
intended, alone or in combination with one or more other drugs or
biologics, to treat a serious or life-threatening disease or
condition and preliminary clinical evidence indicates that the
drug, or biologic, may demonstrate substantial improvement over
existing therapies on one or more clinically significant endpoints,
such as substantial treatment effects observed early in clinical
development. For product candidates that have been designated as
breakthrough therapies, interaction and communication between the
FDA and the sponsor of the trial can help to identify the most
efficient path for clinical development while minimizing the number
of patients placed in ineffective control regimens. Biologics
designated as breakthrough therapies by the FDA may also be
eligible for other expedited approval programs, including
Accelerated Approval.




Designation as a breakthrough therapy is within the discretion of
the FDA. Accordingly, even if we believe one of our product
candidates meets the criteria for designation as a breakthrough
therapy, the FDA may disagree and instead determine not to make
such designation. In any event, the receipt of a Breakthrough
Therapy designation for a product candidate may not result in a
faster development process,review or licensure compared to candidate products considered for
licensure under non-expedited FDA review procedures and does not
assure ultimate approval by the FDA. In addition, even if one or
more of our product candidates qualify as breakthrough therapies,
the FDA may later decide that the product no longer meets the
conditions for qualification. Thus, even though we intend to seek
Breakthrough Therapy designation for some or all of our current or
future product candidates for the treatment of various cancers,
there can be no assurance that we will receive breakthrough therapy
designation."

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