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add2it

02/14/11 9:03 PM

#101 RE: oldberkeley #100

Help: Question for all...
According to this article the FDA has up to 60 days to provide notice of the NDA once the waiver is received. Does this mean our 2/22/11 date is off and it is now 3/14/11 ...60 days after Jan. 14, 2011?
Any help???
Trying to figure out todays drop when we should of been up on news.

Thanks in advance, add2it

Antares Pharma, Inc. (NYSE Amex: AIS) today announced the receipt from the U.S. Food and Drug Administration (FDA) of a waiver, on February 8, 2011, for the $1,500,000 New Drug Application (NDA) filing fee for Anturol ® Gel for overactive bladder (OAB).
More on Press Releases
Antares Pharma Inc.| AIS The waiver, requested by Antares in accordance with section 736(d)(1)(D) of the Federal Food, Drug and Cosmetic Act, is granted to a small business for the first human drug application that it submits to the FDA for review. To be considered for the waiver, a company must demonstrate it meets the size restrictions established by the Small Business Administration (SBA), which the SBA confirmed for Antares on January 14, 2011. The FDA will typically provide notice of acceptance of the NDA within 60 days of receipt of the waiver.