Article preview from "The Gray Sheet" - December 1, 2010
Oceana Therapeutics is hoping to set the stage for FDA approval of its Solesta injectable bulking agent for fecal incontinence with a positive panel recommendation Dec. 2, but first it will have to answer questions about potential data gaps and other issues that the agency has pinpointed in its review of the PMA so far.
Article preview from "The Gray Sheet" - December 1, 2010
Oceana Therapeutics is hoping to set the stage for FDA approval of its Solesta injectable bulking agent for fecal incontinence with a positive panel recommendation Dec. 2, but first it will have to answer questions about potential data gaps and other issues that the agency has pinpointed in its review of the PMA so far.
In materials released Nov. 30 in the lead up to Thursday's meeting of the Gastroenterology and Urology Devices Panel to consider Oceana's PMA, FDA notes that Oceana's treatment claims for the device have "clinical and statistical merit."
But, after extensive analysis, agency reviewers have "a number of concerns which bring into question some of the sponsor's conclusions."
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