Replies to post #124150 on Biotech Values

[oldberkeley]

vin- As it turns out, I couldn't resist the MNTA PPS and bought more of it. PGNX still on my radar.

Best of luck.

[mcbio]

PGNX/SLXP - FDA accepts Relistor sNDA filing

[Any PDUFA tea leaf readers in here? The Action Date is about 8 months away. Is this about an average timeframe for an sNDA filing such as this? If longer than normal, anything bearish to read into that? I'm not really reading anything into it but would love to hear opinions.]

http://finance.yahoo.com/news/Progenics-and-Salix-Announce-bw-1411579576.html?x=0&.v=1

Progenics and Salix Announce FDA Acceptance of sNDA Filing for RELISTOR® in Patients with Non-Cancer Pain
– PDUFA Action Date is April 27, 2012 –

TARRYTOWN, N.Y. & RALEIGH, N.C.--(BUSINESS WIRE)-- Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX - News) and Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP - News) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental New Drug Application (sNDA) for RELISTOR (methylnaltrexone bromide) Subcutaneous Injection to treat opioid-induced constipation (OIC) in patients with non-cancer pain. The FDA has issued an action date of April 27, 2012 under the Prescription Drug User Fee Act (PDUFA).

RELISTOR is a peripherally acting mu-opioid receptor antagonist that counteracts the constipating effects of opioid pain medications in the gastrointestinal tract without affecting their ability to relieve pain. RELISTOR Subcutaneous Injection has been FDA approved since 2008 to treat OIC in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of RELISTOR beyond four months has not been studied.

Bill Forbes, Pharm.D., executive vice president, research and development, and chief development officer at Salix said, “Acceptance of this filing for FDA review is a significant step toward gaining approval for RELISTOR to treat the underlying cause of OIC experienced by the millions of patients taking opioids for non-cancer pain.”

Robert J. Israel, senior vice president of medical affairs for Progenics, added, “This sNDA includes results from 31 studies involving more than 4,000 patients. We are pleased to have the FDA review these data in support of RELISTOR’s safety and efficacy in a new indication.”