Hemispherx BioPharma (HEB)

[NickPar]

Look how many times the FDA was in contact about Savella (as shown in the Savella NDA Approval letter).

August had the most with 11 times and from Aug - Oct there were 24 contacts:

Complete letter found here:
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022256ltr.pdf


NDA 22-256
NDA APPROVAL
Cypress Bioscience, Inc.
c/o Forest Laboratories, Inc.
Harborside Financial Center
Plaza III, Suite 602
Jersey City, NJ 07311

Attention: Michael K. Olchaskey, PharmD
Director, Regulatory Affairs

Dear Dr. Olchaskey:

Please refer to your new drug application (NDA) dated and received December 18, 2007, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Savella (milnacipran HCl) 12.5 mg, 25 mg, 50 mg, and 100 mg Tablets.

We acknowledge receipt of your submissions dated January 18 and 30, February 8, 11, 13, 15, and 28, March 17 and 31, April 10, 17, 22, 28, and 30, May 30, June 2, 9, 10, 11, and 26, July 3, 15, 28, and 30, August 6, 7, 8, 11, 12, 13, 19, 20, 25, 26, and 27, September 2, 5, 16, 17, and 23, and October 8, 9, 10, 14, 15, 16, 17, and 24, 2008, and January 2 and 8, 2009.

This new drug application provides for the use of Savella (milnacipran HCl) Tablets for the management of fibromyalgia.

We have completed our review of this application, as amended, and it is approved, effective on the date of this letter, for use as recommended in the enclosed agreed-upon labeling text.

Your application was not referred to an advisory committee because, although Savella is a new molecular entity, it is not the first drug in the class of norepinephrine-serotonin reuptake inhibitors (NSRIs) indicated for the management of fibromyalgia, the clinical study design was acceptable, and the product did not pose unique concerns beyond those applicable to other members of this class.

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Notice the last paragraph, Savella was not the first drug in the class, whereas Ampligen is. Just an observation that probably has some bearing. IMO, end of October is more likely. But I'd rather believe before Labor Day.

HEB long

GLTA