InvestorsHub Logo
Followers 325
Posts 19225
Boards Moderated 1
Alias Born 02/08/2002

Re: spatelspd post# 82226

Monday, 07/28/2014 7:41:01 AM

Monday, July 28, 2014 7:41:01 AM

Post# of 97237
ACRX CRL info http://finance.yahoo.com/news/inplay-briefing-com-055139997.html
1:35 am AcelRx receives Complete Response Letter from FDA for New Drug Application for Zalviso (ACRX) : Co announces that has issued a Complete Response Letter (CRL) for the Company's new drug application for Zalviso (sufentanil sublingual tablet system). The Company is currently reviewing the FDA's comments and requests contained in the CRL and plans to discuss these requests with the FDA.

The CRL contains requests for additional information on the Zalviso System to ensure proper use of the device.
The requests include provision of bench data demonstrating a reduction in the incidence of optical system errors which require premature drug cartridge change, changes to the Instructions for Use for the device, and additional data to support the shelf life of the product.
Co believes some of the requests have been addressed in amendments to the NDA that have been submitted prior to the receipt of the CRL but, as acknowledged by the FDA, have not been reviewed.
There is no guarantee that the information previously provided to the FDA will be adequate to address the issues in the CRL.
Additional bench testing will be required and human factors testing may be required to address certain items in the CRL.
There were no requests to conduct additional human clinical studies.

Co's Commentary:
"We believe we can satisfy all of FDA's requests in the CRL and resubmit the NDA by the end of 2014, although we will have more clarity on the process and timing after our conversation with FDA.."

1:34 am Aspen Insurance shareholders overwhelmingly reject endurance authorization proposals (AHL) : Aspen Insurance Holdings (AHL) announces that, based on preliminary voting results as of the close of business on July 25, 2014 -- the target date for receiving consents set by Endurance Specialty Holdings (ENH) -- the overwhelming majority of Aspen shareholders participating in the consent solicitation have rejected both of Endurance's proposals.

Based on these preliminary results, as provided by the Company's proxy solicitor, Aspen believes that shareholders owning at least 76% of Aspen's outstanding shares did not support Endurance's proposal to call a special meeting at which shareholders would vote on a proposal to increase the size of Aspen's Board to 19 directors, and shareholders holding at least 81% of Aspen's outstanding shares did not support Endurance petitioning the Supreme Court of Bermuda as part of a legal maneuver called an involuntary scheme of arrangement.
Of these amounts, shareholders holding more than 60% of Aspen's outstanding shares took action to affirmatively reject both proposals on Aspen's blue revocation card. Thus, Aspen estimates that the number of shares affirmatively rejecting both Endurance proposals was at least two-and-a-half times as many as the number that consented.

Join the InvestorsHub Community

Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.