Seelos intends to rely upon third-party CROs, medical institutions, clinical investigators and contract laboratories to monitor and manage data for Seelos'
ongoing preclinical and clinical programs. Nevertheless, Seelos maintains responsibility for ensuring that each of Seelos' clinical trials and preclinical studies is conducted in accordance with
the applicable protocol, legal, regulatory, and scientific standards and Seelos' reliance on these third parties does not relieve Seelos of its regulatory responsibilities. Seelos and its CROs and
other vendors are required to comply with current requirements on good manufacturing practices ("cGMP") good clinical practices ("GCP") and good laboratory practice
("GLP") which are a collection of laws and regulations enforced by the FDA, the EMA and comparable foreign authorities for all of Seelos' product candidates in clinical
development. Regulatory authorities enforce these regulations through periodic inspections of preclinical study and clinical trial sponsors, principal investigators, preclinical study and clinical
trial sites, and other contractors. If Seelos or any of its CROs or vendors fails to comply with applicable regulations, the data generated in Seelos' preclinical studies and clinical trials may be
deemed unreliable and the FDA, the EMA or comparable foreign authorities may require Seelos to perform additional preclinical studies and clinical trials before approving Seelos' marketing
applications. Seelos cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of Seelos' clinical trials comply with GCP
regulations. In addition, Seelos' clinical trials must be conducted with products produced consistent with cGMP regulations. Seelos' failure to comply with these regulations may require it to
repeat clinical trials, which would delay the development and regulatory approval processes.
Seelos may not be able to enter into arrangements with CROs on commercially reasonable terms, or at all. In addition, Seelos' CROs will not be Seelos' employees, and
except for remedies available to Seelos under its agreements with such CROs, Seelos will not be able to control whether or not they devote sufficient time and resources to Seelos' ongoing
preclinical and clinical programs. If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy
of the data they obtain is compromised due to the failure to adhere to Seelos' protocols, regulatory requirements, or for other reasons, Seelos' clinical trials may be extended, delayed or
terminated and Seelos may not be able to obtain regulatory approval for or successfully commercialize Seelos' product candidates. CROs may also generate higher costs than anticipated. As a
result, Seelos' business, financial condition and results of operations and the commercial prospects for Seelos' product candidates could be materially and adversely affected, its costs could
increase, and its ability to generate revenue could be delayed.
Switching or adding additional CROs, medical institutions, clinical investigators or contract laboratories involves additional cost and requires management time and
focus. In addition, there is a natural transition period when a new CRO commences work replacing a previous CRO. As a result, delays occur, which can materially impact Seelos' ability to
meet its desired clinical development timelines. There can be no assurance that Seelos will not encounter similar challenges or delays in the future or that these delays or challenges will not
have a material adverse effect on Seelos' business, financial condition or results of operations.
Seelos' product candidates are subject to extensive regulation under the FDA, the EMA or comparable foreign authorities, which can be costly and time
consuming, cause unanticipated delays or prevent the receipt of the required approvals to commercialize Seelos' product candidates.
The clinical development, manufacturing, labeling, storage, record-keeping, advertising, promotion, export, marketing and distribution of Seelos' product
candidates are subject to extensive regulation by the FDA and other U.S. regulatory agencies, the EMA or comparable authorities in foreign markets. In the U.S., neither Seelos nor Seelos'
collaborators are permitted to market Seelos' product candidates until Seelos or Seelos' collaborators receive approval of a new drug application ("NDA") from the FDA or receive
similar approvals abroad. The process of obtaining these approvals is expensive, often takes many years, and can vary substantially based upon the type, complexity and novelty of the product
candidates involved. Approval policies or regulations may change and may be influenced by the results of other similar or competitive products, making it more difficult for Seelos to achieve
such approval in a timely manner or at all. Any guidance that may result from recent FDA advisory panel discussions may make it more expensive to develop and commercialize such product
candidates. In addition, as a company, Seelos has not previously filed NDAs with the FDA or filed similar applications with other foreign regulatory agencies. This lack of experience may
impede Seelos' ability to obtain FDA or other foreign regulatory agency approval in a timely manner, if at all, for Seelos' product candidates for which development and commercialization is
Despite the time and expense invested, regulatory approval is never guaranteed. The FDA, the EMA or comparable foreign authorities can delay, limit or deny approval
of a product candidate for many reasons, including:
- a product candidate may not be deemed safe or effective;
- agency officials of the FDA, the EMA or comparable foreign authorities may not find the data from non-clinical or preclinical studies and clinical trials generated
during development to be sufficient;
- the FDA, the EMA or comparable foreign authorities may not approve Seelos' third-party manufacturers' processes or facilities; or
- the FDA, the EMA or a comparable foreign authority may change its approval policies or adopt new regulations.
- Seelos' inability to obtain these approvals would prevent Seelos from commercializing its product candidates.