Non-inferiority means that the experimental treatment worked well enough.

‘We are very happy with this new analysis,’ says Dr. Bassam Damaj, President and CEO of Apricus Bio. ‘We believe it may allow us to go forward towards eventual approval of the drug. Scientific trials on the drug started after 2005, when NexMed signed an agreement with Novartis, under which Novartis assumed responsibility to develop and commercialize the drug. The first scientific trials did not show clear-cut efficacy, and in 2008, NexMed announced that the results were not strong enough to aid filing for new drug authorization with the U.S. Food & Medication Administration. Novartis declined to continue to build up the drug in 2009 2009, and NexMed acquired the worldwide rights to the drug, at the mercy of certain obligations to be produced to Novartis.Net product sales decreased primarily because of Cardica’s smaller direct selling force. Because the advancement of the patent foramen ovale closure device under the relationship with Make Medical was placed on temporary hold through the fiscal 2010 second one fourth, no development revenue was recorded during the fiscal 2010 third quarter. Development revenue was $728,000 for the fiscal 2009 third one fourth. Total net revenue was around $1.0 million for the fiscal 2010 third quarter compared to $2.8 million for the fiscal 2009 third quarter.

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