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SEC Filings

10-Q
PROTEON THERAPEUTICS INC filed this Form 10-Q on 11/07/2017
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  · the results of later-stage clinical trials may not meet the level of statistical or clinical significance required by the FDA or comparable foreign regulatory authorities for approval;
  · the results of later-stage clinical trials may not confirm the positive results from earlier preclinical studies or clinical trials;
  · we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;
  · the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;
  · the data collected from clinical trials of vonapanitase or any additional product candidate may not be sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a BLA, or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere;
  · our manufacturing processes or facilities may not be adequate to support approval of our product candidates; or
  · regulatory agencies may change their approval policies or adopt new regulations in a manner rendering our clinical data insufficient for approval.

 

It is possible that neither vonapanitase nor any product candidates we may seek to develop in the future will ever obtain the appropriate regulatory approvals necessary for us or any future collaborators to commence product sales. We do not know whether any clinical trials will begin as planned, or will be revised prior to or during the conduct of the study, completed on time or conducted at all. Any delay in obtaining, or failure to obtain, required approvals would materially adversely affect our ability to generate revenue from the particular product candidate, which likely would result in significant harm to our financial position and adversely impact our stock price.

 

We may face difficulty in enrolling patients for clinical trials.

 

We may find it difficult to enroll patients in our clinical trials, which could delay or prevent completion of clinical trials of vonapanitase or any additional product candidates. Identifying and qualifying patients to participate in clinical trials of vonapanitase or any additional product candidates are critical to our success. The timing of our clinical trials depends on the speed at which we can recruit patients to participate in testing product candidates. The enrollment timeline for radiocephalic fistula patients is lengthy and there are a limited number of sites from which we can enroll pre-hemodialysis or hemodialysis patients. If patients are unwilling to participate in our trials because of negative publicity from adverse events or for other reasons, including the results of completed or competitive clinical trials for similar patient populations, the timeline for recruiting patients, conducting trials and obtaining regulatory approval of potential products may be delayed or prevented. These delays could result in increased costs, delays in advancing our product development, delays in testing the effectiveness of our technology or termination of the clinical trials altogether. We may not be able to identify, recruit and enroll a sufficient number of patients, or those with required or desired characteristics to achieve diversity in a trial, to complete our clinical trials in a timely manner. Patient enrollment is affected by numerous factors including:

 

  · severity of the disease under investigation;
  · design of the trial protocol;
  · size and nature of the patient population;
  · eligibility criteria for the trial in question;
  · perceived risks and benefits of the product candidate under study;
  · proximity and availability of clinical trial sites for prospective patients;
  · availability of competing therapies and clinical trials;
  · efforts to facilitate timely enrollment in clinical trials;
  · our ability to obtain and maintain subject consents;
  · the risk that enrolled subjects will drop out or be withdrawn from our studies;
  · patient referral practices of physicians;
  · ability to monitor patients adequately during and after treatment; and
  · the ability of subjects to comply with the clinical trial visit schedule and procedures.

 

We may not be able to initiate or continue clinical trials if we cannot enroll a sufficient number of eligible patients to participate in the clinical trials required by regulatory agencies. If we have difficulty enrolling a sufficient number of patients to conduct our clinical trials as planned, we may need to delay, limit or terminate ongoing or planned clinical trials, any of which would have an adverse effect on our business.

 

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