Company: PRTA
Filing Date: 2025-11-06
Form Type: 10-Q
Source: 0001559053-25-000044
Chunk: 66

Company: PROTHENA CORP PUBLIC LTD CO
Filing Date: 2025-11-06
Form: 10-Q
Item: Part II, Item 1A
Chunk 66
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 interpretation of data from nonclinical studies or clinical trials;

• the data collected from clinical trials of our drug candidates may not be sufficient to support the submission of a Biologics License Application (“ BLA”) or a New Drug Application (“ NDA”) to the FDA, a Marketing Authorization Application (“ MAA”) to the EMA, or similar applications to comparable regulatory authorities;

• the FDA, the EMA, or comparable regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; or

• the approval policies or regulations of the FDA, the EMA, or comparable regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

Further, even after submission and acceptance of a BLA, NDA, MAA, or other similar application to an applicable regulatory authority, there is, for example, the potential for the regulatory authority to not act by, or delay, a target goal date due to internal resource constraints or other reasons. In the U. S., the FDA has agreed to specified performance goals in the review of applications under the Prescription Drug User Fee Act (“ PDUFA”). One such goal is to complete standard review of an application in ten months and priority review of an application in six months, whereupon a review decision is to be made. For a new molecular or new chemistry entity, this review period follows a 60-day period during which FDA determines whether to accept the application for review. FDA does not always meet its PDUFA goal dates for standard and priority review applications. The review process and the PDUFA goal date may be extended by three months if the FDA requests or the application sponsor otherwise submits additional information or clarification regarding information already provided in the submission within the last three months before the PDUFA goal date.

This lengthy, complex approval process, as well as the unpredictability of future clinical trial results, may result in our failing to obtain regulatory approval to market our drug candidates, which would significantly harm our business, results of operations, and/or growth prospects.

In addition, even if we were to obtain approval, regulatory authorities may approve any of our drug candidates for fewer or more limited indications than we request, may grant approval contingent on the performance of costly post-approval clinical trials or other post-approval commitments or requirements, or may approve our drug candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that drug candidate. Any of the foregoing scenarios could materially harm the commercial prospects for