Wednesday, May 29, 2013 8:25:05 PM
PDUFA - May 31, 2013 - Conservative estimates are approximately 25 - 35 million revenue!!! 
Press release from CEO from last month!!!
"First, as we mentioned on prior calls, our first NDA submission for a new hospital based product is at the FDA, and we continue to feel that we have brought our best resources in clinical and regulatory affairs to bear in the preparation of the submission. The FDA’s PDUFA target action date for our NDA is May 31, 2013.
We’re actively preparing for product launch, while we await the FDA’s action. We expect to have the product available to providers and patients as quickly as possible after an approval. If the product is approved on time, we expect the product to generate meaningful sales in 2013, and to have a positive impact on our financial results by the end of the year. The product is targeted for the hospital setting, and it could contribute from $25 million to $35 million in peak annual revenues for Flamel."
LOAD UP THE TRUCK!!!
Press release from CEO from last month!!!
"First, as we mentioned on prior calls, our first NDA submission for a new hospital based product is at the FDA, and we continue to feel that we have brought our best resources in clinical and regulatory affairs to bear in the preparation of the submission. The FDA’s PDUFA target action date for our NDA is May 31, 2013.
We’re actively preparing for product launch, while we await the FDA’s action. We expect to have the product available to providers and patients as quickly as possible after an approval. If the product is approved on time, we expect the product to generate meaningful sales in 2013, and to have a positive impact on our financial results by the end of the year. The product is targeted for the hospital setting, and it could contribute from $25 million to $35 million in peak annual revenues for Flamel."
LOAD UP THE TRUCK!!!
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