KURVE COMPASSIONATE USE

Site Enrollment & Form 3926

Single submission. Dropdowns wherever possible. Your e-signature at the end binds all of it together.

1. Physician & practice information

Corresponds to Form 3926 Section 1 (contact information). These fields will be embedded verbatim into the form we file with FDA.

1b. Physician qualification statement

Form 3926 Item 8 — FDA requires either a structured qualification statement (medical school, year of graduation, specialty, state license, current employment, job title) or the first few pages of your CV. Provide either or both.

Max 10 MB. Your CV will be attached to the filled FDA Form 3926 as a PDF file attachment so FDA sees it in one submission.

2. Patient profile

Form 3926 Section 2 — de-identified patient description. Use initials only; full patient details are collected separately through the patient's own enrollment link (step 5 below).

3. Proposed treatment

Form 3926 Section 3 — investigational product and administration plan. Kurve ViaNase device is pre-selected.

4. Sponsor Letter of Authorization

Form 3926 Section 4 — reference to the sponsor's IND. Auto-populated from Kurve Therapeutics for this program. You do not need to provide this.

Pre-populated: Beacon will attach the Kurve Therapeutics Letter of Authorization permitting cross-reference to IND #[KURVE-IND-####] for this application. You do not need to obtain the LOA yourself.
5. IRB concurrence

Form 3926 Section 6 — IRB oversight statement. Beacon provides umbrella coverage through our partner IRB; no action required from you.

Pre-populated: This site will be added as a participating site under the Healing Hope International / Beacon Clinical Registry central IRB for the applicable observational protocol. IRB concurrence letter will be attached to the Form 3926 package before FDA submission.
6. Informed consent commitment
7. Observational studies you want to join

Select one or both. Enrolled patients whose therapy matches a study's inclusion criteria will be offered registry participation.

8. Electronic signature

By typing your full legal name and checking the attestation, you apply a legally binding electronic signature under the ESIGN Act. Your submission timestamp and IP address will be recorded as part of the audit trail.

Electronic signature block

Your submission is encrypted and stored on U.S.-based servers. Beacon will not share your information with any party outside the regulatory submission workflow (FDA, IRB, Kurve Therapeutics) without your written consent.