The Complete Response Letter received by AcelRx in July 2014 in response to the Zalviso NDA contained requests for additional information on the Zalviso System to ensure proper use of the device. The requests included provision of data demonstrating a reduction in the incidence of system errors, changes to the Instructions for Use for the device, and additional data to support the shelf life of the product. In the CRL, there were no requests to conduct additional human clinical studies. The CRL specifically identified Human Factors studies as appropriate to assess the changes to the instructions for use for the device.
Found this coment on seekingalpha makes sense. The only explanation for no conference call after approval is a pending buy out by Baxter. They could not answer question about roll out and price since Baxter would be making those decisions