(EMAILWIRE.COM, April 23, 2012 ) New York, NY -- VFC's Stock House, an information and research outlet that brings ideas and opens discussions to a broad spectrum of investors, believes that an extended FDA approval decision time frame for a competitor will allow Synergy Pharmaceuticals (SGYP) to play catch up in the race to full commercialization.
Ironwood Pharmaceuticals (IRWD) and partner Forest Laboratories, Inc. (FRX) informed investors on Monday that the FDA will take an additional three months to review data for Linaclotide, which is before the FDA for review in the indications of chronic idiopathic constipation (CIC) and constipation-predominant irritable bowel syndrome (IBS-C).
The fact that now Synergy has a full quarter's worth of time to play catch up is key.
Results from the ongoing Phase II/III Plecanatide trial are due later this year, and as mentioned, thus far the product has not been known to cause the side effect of severe diarrhea, as has Linaclotide. With a new lease on time and the favorable side effect data, Plecanatide's early market potential has become consequentially strengthened with Monday's announcement of an extended FDA review period.
The news also comes at a time when big pharma is on the prowl to purchase smaller companies, making Synergy that much more of an attractive story.
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