Company: SRPT
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0000950170-25-029973
Chunk: 197

Company: Sarepta Therapeutics, Inc.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 197
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 to complete clinical trials within the expected timeframe. Patient enrollment can be impacted by factors including, but not limited to:

•design and complexity and/or commitment of participation required in the study protocol;

•size of the patient population;

•diagnostic capabilities within patient population;

•eligibility criteria for the study in question;

•clinical supply availability;

•delays in participating site identification, qualification and subsequent activation to enroll;

•perceived risks and benefits of the product candidate under study, including as a result of adverse effects observed in similar or competing therapies;

•proximity and availability of clinical trial sites for prospective patients;

•availability of competing therapies and clinical trials;

•competition of site efforts to facilitate timely enrollment in clinical trials;

•participating site motivation;

•patient referral practices of physicians; 

•activities of patient advocacy groups;

•ability to monitor patients adequately during and after treatment; and

•severity of the disease under investigation.

In particular, each of the conditions for which we plan to evaluate our product candidates are rare genetic diseases with limited patient pools from which to draw for clinical trials. Further, because newborn screening for these diseases is not widely adopted, and it can be difficult to diagnose these diseases in the absence of a genetic screen, we may have difficulty finding patients who are eligible to participate in our studies. The eligibility criteria of our clinical trials will further limit the pool of available study participants. Additionally, the process of finding and diagnosing patients may prove costly. The treating physicians in our clinical trials may also use their medical discretion in advising patients enrolled in our clinical trials to withdraw from our studies to try alternative therapies. In addition, pandemics and other national or regional health emergencies may impact patient ability and willingness to travel to clinical trial sites as a result of quarantines and other restrictions, which may negatively impact enrollment in our clinical trials.

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We may not be able to initiate or continue clinical trials if we cannot enroll the required eligible patients per protocol to participate in the clinical trials required by the FDA or the EMA or other regulatory agencies. Our ability to successfully initiate, enroll and complete a clinical trial in any foreign country is subject to numerous risks unique to conducting business in foreign countries, including:

•difficulty in establishing or managing relationships with contract research organizations (“CROs”) and physicians;

•different standards for the conduct of clinical trials;

•our inability to locate qualified local consultants, physicians and partners; 

•the potential burden of complying with a variety of foreign laws, medical standards and regulatory requirements, including the regulation of