Team IPLEX - We Need Your Help

Dear friends, family, & supporters,

I am once again, requesting help from any and all family, friends, & supporters . Please Review the above attachments we (Team IPLEX) have provided...

You can... cut and paste certain talking points from the attachments, or... you can just cut and paste the entire document - as is. (of course don't forget to, change the address, name, and salutation's.) then double-click each Web link below, (which will open up that particular FDA officer's e-mail voicing your support for this (PALS) cause.

All We Are Asking ... is that they (the FDA hierarchy), provide us (PALS) a more data-driven reason/argument, for denying American PALS a drug/therapeutic, that the Italian government are paying Millions of Dollars annually (on behalf of their citizenry), for the specific Treatment of ALS. Is That Really Too Much to Ask ?... Just show us the proof, that -- IPLEX Is Dangerous, and we'll all go away and shut up.

What's with all the secrecy ? What ever happened to openness and transparency? - What's with the... MY WAY OR HIGHWAY attitude of Dr. Katz? ... Finally, why haven't the Italian government, refused to stop paying, the Millions of Dollars (annually), for reasons that, IPLEX Is Dangerous and or Ineffective.?


Yes, roadblocks (FDA ) exist that prevent immediate access to Iplex ,but just like the last time we went up against Goliath, we are making progress. Last week, Stephen Byer (Team IPLEX Capt.) & his nonprofit organization - ALS worldwide, met with two Illinois legislators, who have promised, and are already showing, their support, of our effort to secure Iplex.



Therefore, we (Team IPLEX) are attaching documents in both PDF format and Microsoft Word format for your immediate use:





Please Take 10-15 minutes and Help, because for myself & other PALS, it truly is - A Race against Time.


Either of these documents can be copied and pasted into either media or congressional websites by using the Microsoft Word versions attached. Or, they can be sent, as is, to those for whom you have an email address by using the PDF files as attachments.




At the latter part of 2008, we (Team IPLEX & supporters) were collectively successful in doing what some said, was impossible - we can do it again but not without your help.




Immediately below are FDA contacts beginning with Dr. Russell Katz, the individual who appears responsible for the current FDA decision to deny Iplex to the ALS community. We urge that you send a copy of both the Congressional letter and the press release to each and every one of the following FDA personnel.



Please... contact Drs Katz, Temple, Jenkins, Woodcock, Torti and Ms. Behr -- Today. Together we can change the FDA decision and gain access to Iplex immediately.





Dr Russell Katz

Division Director, Neurology Products

301-796-2250 Tel

301-796-9842 Fax

russell.katz@fda.hhs.gov



His Superior:

Dr Robert Temple

Office of Medical Policy

301-796-2270 Tel

301-796-9840 Fax

robert.temple@fda.hhs.gov



His Superior:

Dr John Jenkins

Office of New Drugs

301-796-0700 Tel

301-796-9856 Fax

john.jenkins@fda.hhs.gov



His Superior:

Dr Janet Woodcock

Office of the Center Director

301-796-5400 Tel

301-847-8752 Fax

janet.woodcock@fda.hhs.gov



Her Superior:

Dr Frank M Torti

Acting Commissioner, FDA

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

Frank.torti@fda.hhs.gov



FDA Ombudsman:

Virginia L. Behr
Office of the Chief of Staff
FDA Center for Drug Evaluation and Research

301-796-3436 Tel

301-847-8452 Fax
Email: CDERombudsman@fda.hhs.gov


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If You Are Interested in joining our efforts please contact me and I will send you The Attachment's

Edward W. Esparza
Schiller Park, IL 60176

e.esparza@Comcast.net



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