Friday, June 29, 2018

Porphyria POST regarding Letters & Trial Info

You can be a medical hero! A new investigational drug for EPP is ready for clinical trial. All we need to begin is YOU! The trial spots will fill up fast…join now! Contact the APF on 1-866-APF-2635 or email
porphyrus@porphyriafoundation.org to be connected to a study site. Don’t wait! Remember…Research is the
Key to Your Cure!


An oral investigational drug has been developed with the potential to increase sunlight duration and tolerance in
individuals with EPP. This phase II clinical trial is needed to understand if the investigational drug works and to
ensure that it is safe. The study duration is 24 weeks including follow-up. You must be age 18-70 to participate
and have a confirmed diagnosis of EPP. All travel is included and will be arranged by a concierge service.


"Remember...Research is the key to YOUR cure!"


Each Step Toward Finding an Effective Treatment is Important!


Porphyria Post
Request
The New Drug Application for Scenesse has been submitted to the FDA.
Now is the time to work hard as patient advocates.
The APF is launching a new campaign to request Priority Review
Now is the time to send your letter requesting priority review for Scenesse. We need to move Scenesse, a long-awaited treatment for EPP, through the regulatory process as quickly as possible. Now that a complete new drug application has been submitted to the FDA - they have the option of granting priority review which moves the process faster. Please share with the FDA...
* That there is no treatment for EPP
* That there is an unmet medical need for a treatment for EPP
* That living with EPP is a tremendous burden
* How living with EPP affects your quality of life
It is important that you send your signed letter to the APF immediately.
Begin your letter:
Scott Gottlieb, M.D.
FDA Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Dear FDA Commissioner:
Mail your letter to:
American Porphyria Foundation
4915 St. Elmo Avenue, Suite 105
Bethesda, Maryland 20814
Alternatively you can scan your signed letter and email it to porphyrus@porphyriafoundation.com.
All letters must be signed.

We will present all of the letters at once to the FDA!
Please send letters today or ASAP! Time is of the Essence!

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